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SURVEY ON USE OF EARLY KNEE PROTOCOL

Survey on the Use of the Early Knee Protocol when

Fitting Infants with Transfemoral Prostheses

Ashley N. Watkins, OPS-III

Mentor: Joshua B. Utay, CPO, M.Ed.

School of Allied Health Sciences, Baylor College of Medicine, Houston, TX


SURVEY ON THE USE OF THE EARLY KNEE PROTOCOL WHENFITTING INFANTS WITH TRANSFEMORAL PROSTHESES

Ashley Watkins, OPS-III

Abstract

Children with limb loss at or above the knee have traditionally been fit with a prosthesiswithout an articulating knee until they are able to walk independently on a locked kneeprosthesis. Recently, data have supported fitting these children with an articulating knee on theirfirst prosthesis. This new fitting protocol is referred to as the Early Knee Protocol. Since this newcollection of data, no study has been conducted determining the frequency with which the EarlyKnee Protocol is followed by prosthetists. It was hypothesized that the majority of prosthetistsfollow the Conventional Protocol, or fitting patients with a locked knee prosthesis until they areable to walk independently. A survey was created using Survey Monkey and was distributed toprosthetists across the United States via email. The survey was used to gauge the relativefrequency prosthetists follow the Early Knee Protocol versus the Conventional Protocol. Of the12 respondents, 63.64% (n=7) reported they follow the Early Knee Protocol indicating that moreprosthetists follow the newer method than was hypothesized. As this protocol gains even wideracceptance, further research should determine the risk-to-benefit ratio of fitting infants with anarticulating knee on their first prosthesis versus a locked knee.


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Introduction

Until 1999, no research had been conducted determining the appropriate time to fit infants with

limb loss at or above the knee with an articulating knee joint. There are currently two primary

protocols used in the treatment of this patient population. The Conventional Protocol is defined

as fitting the infant with either a locked knee joint or no knee joint at all while he or she is

learning to walk.1-3 The primary reason cited for following this protocol is to provide a stable

prosthesis for the child to learn to walk.3 Many practitioners still abide by this fitting protocol

when treating their young patients with limb loss at or above the knee.1-3 Typically, these

practitioners fit infants with a locked knee prosthesis when the child begins to pull to stand. Once

the child has mastered walking with a locked knee and has reached a level of intellectual

maturity at which they can be taught how to operate an articulating knee joint, they will then

begin gait training with an articulating knee. This is usually around the age of three to four years

old.1,3

Data have recently been gathered supporting the need for infants to be fit with an articulating

knee joint as soon as possible. This protocol is defined as the Early Knee Protocol.4 Research

supporting this protocol, however, is limited, and more research is needed to support it. Many

practitioners are still using the Conventional Protocol when fitting this population with

prostheses and have not yet adopted this new way of practice. The primary reasons cited for

following this protocol are the developmental and physical benefits it provides for the patients

due to the more normalized crawling patterns permitted.1,2,4-6 The developmental benefits of

crawling are well understood.7 When infants are fit with a locked knee prosthesis, they are forced

to crawl with a deviation. This deviation inhibits their crawling ability and can cause

developmental delays by limiting sufficient interaction with their environment.2,4-7 Studies have


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shown that infants fit with an articulating knee joint exhibit crawling patterns very similar to

their able-bodied peers. The earlier the patient is fit with an articulating knee joint, the more

likely it is the child will have normalized crawling patterns and normal cognitive

development.2,4,6,7 By fitting an infant with an articulating knee joint on his/her initial prosthesis,

the infant is able to develop at a normal rate and meet their developmental milestones as well as

their non-amputated peers. An articulating knee will also prevent the development of gait

deviations that could inhibit proper musculoskeletal development.1,2,4,7

Research on this topic is limited. There are no published studies examining the frequency with

which prosthetists follow the Early Knee Protocol versus the Conventional Protocol. While the

Early Knee Protocol is beginning to gain attention from prosthetists, it is assumed that many

prosthetists are unaware of this new protocol or believe there are too many disadvantages to

following it. This survey was designed to determine the frequency at which the Early Knee

Protocol is followed.

Hypotheses and Objectives

The Conventional Protocol for treating patients with limb loss at or above the knee involves

beginning with a non-articulating prosthesis and only fitting articulating knee joints when the

patient is able to walk independently with the locked knee joint. This survey studied whether

most prosthetists in the United States subscribe to the Conventional Protocol or apply the Early

Knee Protocol by supplying an articulating knee initially.

Secondary purposes of this study include determining reasons for following a particular protocol,

the age or developmental milestone at which patients are most commonly fit with an articulating


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prosthetic knee, brands and types of prosthetic knees most commonly fit by prosthetists for this

population, common problems faced by prosthetists when fitting them, and characteristics of

prosthetics knees preferred by prosthetists.

Methods

This study, protocol number H-36369, was approved by the Baylor College of Medicine’s

(BCM) Institutional Review Board (IRB) on July 16, 2015. See Appendix C for a copy of the

study protocol and application approved by the BCM IRB.

Participants included BOC- (Board of Certification in Orthotics and Prosthetics) and ABC-

(American Board for Certification in Prosthetics, Orthotics, and Pedorthics) certified prosthetists

in the United States who have fit one or more pediatric prosthetic patients with limb loss at or

above the knee under the age of five in their career. The survey was sent to prosthetists in all

regions of the United States.

The nine-question survey was designed on Survey Monkey (www.surveymonkey.com) to

address the primary objective of this study and to collect additional information concerning

fitting of this patient population. See Appendix A for a copy of the survey. A link to the online

survey was distributed to prosthetists around the United States in an email through the O&P List

Serve (www.oandp.com/oandp-l). See Appendix B for a copy of this email. The survey was open

for responses for one month. A follow-up email including the link to the survey was sent two

weeks after the initial email, and a third and final email including a link to the survey was sent

two weeks after the second email. Only prosthetists who had fit one or more pediatric patients

http://www.surveymonkey.com/

http://www.oandp.com/oandp-l


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under the age of five years with limb loss at or above the knee were included in the survey

results.

The responses to the survey were collected through Survey Monkey and were analyzed using

Excel. Due to the limited number of valid responses collected, the primary data analysis used

was percentage of total responses. Chi-squared tests were used to determine statistical

significance of relationships in the data collected. The alpha value used was 0.05.

Results

This study included survey responses from 15 practitioners. Three of the 15 respondents reported

never having fit a pediatric prosthetic patient under the age of five with limb loss or deficiency at

or above the knee. By protocol, these three participants were excluded in the analysis of data.

Twelve practitioners had valid survey responses that were used in tallying results.

The primary purpose of this study was to determine the relative frequency the Conventional

Protocol is followed versus the Early Knee Protocol. The hypothesis that the Conventional

Protocol is more commonly followed than the Early Knee Protocol was not supported. Nearly

two-thirds, or 63.64% (n=7), of practitioners responded that they follow the Early Knee Protocol,

with the remaining 36.36% of respondents ascribing to the Conventional Protocol (Figure 1).

Demographics

Of all respondents, 47% (n=7) practiced in Medicare region C (Table 1). The region in which the

respondents practiced was unrelated to which protocol was followed (p = 0.76).


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Of all respondents, 27% (n=4) reported treating 1-6 pediatric prosthetic patients under the age of

five years with limb loss or deficiency at or above the knee in their career, and an additional 27%

(n=4) have seen 7-15 patients in their career. One-fiftth (n=3) of reported seeing more than 26

patients of this type in their career (Table 2).

The Medicare region in which the respondents practiced was unrelated to the volume of pediatric

prosthetic patients treated under the age of five (p = 0.53). However, the protocol followed is

directly related to the number of patients seen by a practitioner (p = 0.038).

Protocol Choice Reasons

Respondents were asked to choose one or more reasons for following the Conventional Protocol

or Early Knee Protocol. Three of the four respondents who reported they follow the

Conventional Protocol cited safety of the patient as one of the two primary reasons for following

this protocol (Figure 2). Seventy-five percent (n=3) of respondents who follow the Conventional

Protocol also cited being able to teach the patient how to use an articulating knee as another

primary reason for following this protocol (Figure 2). Other reasons cited included the facility or

the referral source dictating the respondents use this particular protocol. A great majority of

respondents who stated they follow the Early Knee Protocol, 85.71% (n=6), cited physical

benefits as the reason for following this protocol (Figure 3), and slightly fewer respondents,

71.43% (n=5), cited developmental benefits as a reason for following this protocol (Figure 3).

No other reasons for were indicated.

Factors Considered in Choosing Time to fit Patient with Articulating Knee

Whether a practitioner followed the Conventional Protocol or the Early Knee Protocol, he/she

still must decide when to fit the patient with an articulating knee. Over a quarter, 28.57% (n=4),


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of all respondents chose the patient’s cognitive development as a factor to consider when

deciding the appropriate time to fit their patients with an articulating knee (Figure 4). Closer to

one-fifth of respondents, 21.43% (n=3), reported their patient’s ability to stand independently as

a factor they consider when deciding the appropriate time to fit him/her with an articulating knee

(Figure 4). The same number of respondents, 21.43% (n=3), reported their patient’s ability to

pull from sitting to standing as a factor they consider when deciding the appropriate time to fit

him/her with an articulating knee (Figure 4). The factors considered when choosing to fit an

infant with an articulating prosthetic knee were deemed statistically unrelated to the protocol the

prosthetist followed (p = 0.22).

Prosthetic Knees

The Össur Total Knee Jr. was the pediatric prosthetic knee fit most frequently by prosthetists

participating in this study, at a rate of over 90% (n=10; Figure 5). The Fillauer Mighty Mite was

the second knee most commonly fit by prosthetists (54.55%, or n=6; Figure 5). Other knees fit

by prosthetists that were not included in the original survey question included: Proteor 1M112,

DAW pneumatic polycentric pediatric knees, and the Seattle Child’s Play. Over half, or 54.5%

(n=6), of practitioners who chose the Össur Total Knee Jr. follow the Early Knee Protocol. The

knee unit chosen for a patient correlates to which protocol the practitioner follows (p = 0.047).

Problems Encountered with Pediatric Prosthetic Knees

Respondents following both protocols were combined in the analysis of problems encountered

with pediatric prosthetic knees. Respondents could choose multiple problems that they

encountered. A lack of pediatric hydraulic knees was listed as an additional problem faced by

practitioners. All respondents reported problems with the build height of pediatric prosthetic


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knees, the weight of the knees, limited adjustability, and poor durability of the knees available

(Figure 6). Most respondents, 83.33% (n=10), reported problems with the unlocking mechanism

of pediatric prosthetic knees (Figure 6), while two-thirds of respondents (n=8), reported

problems with the locking mechanism of pediatric knees (Figure 6).

Characteristics of Knees Considered

Respondents following both protocols were combined in the analysis of characteristics of

pediatric prosthetic knees most often considered when choosing a knee for a patient.

Respondents could choose multiple responses to this question. The most important

characteristics of pediatric prosthetic knees were: low build height, lightweight, polycentric, and

inclusion of an extension assist. Adjustable flexion resistance (i.e. constant friction), and

durability were other characteristics listed by respondents as important aspects of pediatric

prosthetic knees. All of the respondents consider lightweight and inclusion of an extension assist

important characteristics of pediatric prosthetic knees. Nearly all of respondents, 92% (n=12),

consider knees with low build heights when choosing a knee for their patient, while 85% (n=11)

of respondents try to choose polycentric knees for their pediatric patients. Remaining features

respondents deemed important when deciding which knee to fit on such a patient (Figure 7)

include: manual lock (69%; n=9), stance flexion feature (62%; n=5), and cost (54%; n=6).

Discussion

The primary purpose of this survey was to determine the relative frequency prosthetists follow

the Early Knee Protocol (fitting pediatric prosthetic patients with an articulating knee on their

first prosthesis) or the Conventional Protocol (fitting patients with a locked knee until they can


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be taught to use an articulating knee). Most prior research on the subject of fitting infants with

prosthetic knees has been done in order to determine if there are benefits to fitting infants with

articulating knees at an earlier age.1,2,4-6 Before this work, no study had either compared

prosthetists following the Early Knee Protocol with those who ascribe to the Conventional

Protocol, or even determined if there are appreciable numbers of prosthetists following the Early

Knee Protocol. Consequently, the data gathered in this study cannot be compared with other

literature. Data gathered suggest more prosthetists follow the Early Knee Protocol than was

hypothesized. The majority of participants in this study reported they follow the Early Knee

Protocol. Because of the small sample size, results cannot be safely generalized to the entire

population of prosthetists in the United States.

The primary reasons chosen for following the Early Knee Protocol included the physical and

developmental benefits of fitting an infant with an articulating knee on his/her first prosthesis.

Studies on this topic have found that patients with an articulating knee will utilize the knee in

crawling2,4,5 and benefit from the process. Because of the importance of crawling in a child’s

development, a prosthetic knee component allowing a patient to crawl without severe deviations

may consequently aid in more normal child development.2,4,7 Preventing crawling deviations in

patients with limb loss at or above the knee may also prevent abnormal musculoskeletal

development that could result from crawling with deviations during critical growth periods.2,4

By contrast, prosthetists following the Conventional Protocol do so primarily due to safety

concerns for the patient learning to ambulate on a knee that will flex. These practitioners fit their

patients with articulating knees once the patients are mature enough to be taught how to use a

knee that will flex. They tend to feel that the patient is in danger of injuring himself/herself if fit

with an articulating knee at too early an age.3 More research is needed to determine if the


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benefits of the Early Knee Protocol outweigh the safety concerns of fitting an articulating knee

on a patient’s first prosthesis. Studies could also determine whether safety is a viable concern

when choosing not to fit an infant with an articulating knee.

The factors considered in deciding the appropriate time to fit a patient with an articulating knee

were unrelated to the protocol employed. It was hypothesized that prosthetists following the

Early Knee Protocol would fit their patients at a certain developmental stage, probably at

independent sitting, while practitioners following the Conventional Protocol would fit their

patients at a different developmental stage, most likely at a cognitive level allowing them to learn

the operation of an articulating knee.1,3 The data collected in this survey actually demonstrate

that most prosthetists, regardless of the protocol they follow, wait until the patient can be taught

how the knee operates before they fit him/her with an articulating knee. It is unclear whether this

question was poorly worded causing the data to be skewed or if the respondents were possibly

uncertain about the definitions of the two different protocols.

Many difficulties of fitting infants with articulating knees at an earlier age than is conventional

stem from mechanical problems with pediatric prosthetic knees. Questions were included in this

survey addressing pediatric prosthetic knees to highlight the challenges most often encountered

in pediatric knees. Össur’s Total Knee Jr. was the knee most often fit by prosthetists leading to

the conclusion that this knee must have most characteristics that practitioners are looking for in

pediatric knees. The characteristics of knees most often considered by practitioners when

choosing a pediatric knee to fit included: low build height, lightweight materials, and inclusion

of an extension assist. Some respondents included prosthetic knees in their responses that were

not included in the survey question. The results may have been different if these additional knees

had been included in the answer choices. The problems encountered most often with pediatric


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prosthetic knees included a tall build height, limited adjustability of the knee, and poor

durability. A lack of pediatric hydraulic knees was listed as an additional problem faced by

practitioners. More prosthetists may follow the Early Knee Protocol if there were an appropriate

pediatric prosthetic knee available on the market. Such a device would need to include all

characteristics they felt were necessary for their patients to be fit with an articulating knee with

their first prostheses. Additional research needs to be conducted to possibly address these

problems in the design of future pediatric prosthetic knees.

Conclusion

Prosthetists following both the Early Knee Protocol and the Conventional Protocol reported they

typically fit patients with articulating prosthetic knee joints once the patients are able to be taught

how to use the knee joint. Additional research could determine the appropriate age or

developmental stage at which to fit an infant with limb loss at or above the knee with an

articulating knee joint.1,2,4,6

The most common knee fit by prosthetists on patients under five years of age with limb loss at or

above the knee was the Össur Total Knee Jr. The problems experienced when fitting pediatric

knees reported most frequently by the respondents were: overall build height, total weight,

limited adjustability, and durability. The characteristics of knees considered most frequently by

prosthetists when fitting infants with prosthetic knee joints included: overall build height,

lightweight, polycentric knee axis, and inclusion of an extension assist. Further research and

development is indicated in order to design more appropriate pediatric prosthetic knee joints.


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This survey demonstrated that many prosthetists are beginning to follow the Early Knee

Protocol. Developmental and physical benefits were the primary reasons for following the Early

Knee Protocol. Safety of the patient and being able to teach the patient how to make use of an

articulating knee joint properly were the primary reasons cited for following the Conventional

Protocol. It is yet to be determined whether the benefits of the Early Knee Protocol outweigh the

benefits of the Conventional Protocol. More research is needed to support the benefits of the

Early Knee Protocol and gain the attention of more prosthetists in the United States.


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References

1. Wilk BS, Karol L, Halliday S, et al. Transition to an articulating knee prosthesis in pediatricamputees. J Prosthet Orthot 1999;11(3):69-74. Available at www.oandp.org. Accessed October8, 2014.

2. Geil M, Coulter-O'Berry C. Temporal and spatial parameters of crawling in children with limbloss: implications on prosthetic knee prescription. J Prosthet Orthot 2010;22(1):21-25. Availableat: www.oandp.org. Accessed October 8, 2014.

3. Cummings D, Kapp S. Lower limb pediatric prosthetics: general considerations andphilosophy. J Prosthet Orthot 1992;4(4):196-206. Available at www.oandp.org. AccessedOctober 8, 2014.

4. Geil M, Coulter-O’Berry C, Schmitz M, Heriza C. Crawling kinematics in an early kneeprotocol for pediatric prosthetic prescription. J Prosthet Orthot 2013;25(1):22. Available atwww.oandp.org. Accessed October 8, 2014.

5. Geil M, Coulter-O’Berry C, Giavedoni B. Effectiveness of early prosthetic knee function ininfants and toddlers. Acad Today 2007;3(1):A10-A11. Available at: www.oandp.org. AccessedDecember 1, 2014.

6. Geil M, Coulter-O’Berry C. Biomechanical response to immobilization of the knee joint ininfant and toddler crawling. Am Acad Orthot Prosthet J Proc Available at www.oandp.org.Accessed December 1, 2014.

7. Adolph KE. Babies’ steps make giant strides toward a science of development. Infant BehavDev 2002;25:86-90.

http://www.oandp.org/






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Tables and Figures

Figure 1. Percentage of respondents who reported they follow the Conventional Protocol versus

those who reported they follow the Early Knee Protocol.

A B C D Unknown Total

Conventional Protocol 0 1 2 0 2 5

Early Knee Protocol 1 1 4 2 0 8

No Protocol Chosen 0 0 1 1 0 2

Total 1 (7%) 2 (13%) 7 (47%) 3 (20%) 2 (13%) 15

Table 1. Comparison of Medicare Region in which prosthetists following the Conventional

Protocol and prosthetists following the Early Knee Protocol practice.


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0 1-6 7-15 16-25 26+ Total

Conventional Protocol 1 1 2 1 0 5

Early Knee Protocol 0 3 2 0 3 8

No Protocol Chosen 2 0 0 0 0 2

Total3

(20%)

4

(27%)

4

(27%)

1

(7%)

3

(20%)

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Table 2. Comparison of the number of pediatric prosthetic patients under the age of five with

limb loss at or above the knee fit by practitioners following the Conventional Protocol and

practitioners following the Early Knee Protocol. Number of patients included patients fit over the

course of a practitioner’s career as a prosthetist.

Figure 2. Reasons for following the Conventional Protocol and the number of respondents who

chose each reason as justification for following this protocol.


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Figure 3. Reasons for following the Early Knee Protocol and the number of respondents who

chose each reason as justification for following this protocol.

Figure 4. Factors considered when deciding appropriate time to fit an infant with an articulating

knee and the number of respondents who consider each factor.


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Figure 5. Popular pediatric prosthetic knees and the number of respondents who commonly fit

their patients with each knee.

Figure 6. Problems commonly encountered with pediatric prosthetic knees and the percentage of

respondents who reported they encounter each problem.


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Figure 7. Characteristics of pediatric prosthetic knees considered when choosing a knee for a

pediatric patient and the percentage of respondents who reported they consider each

characteristic.


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Appendices

Appendix A – Survey

Prosthetic Knee Fitting Protocols for Pediatric AmputeesProsthetic Knee Fitting Prototcols for Pediatric Amputees

The purpose of this survey is to determine the most commonly used protocol in the UnitedStates for fitting pediatric amputees with prosthetic knees. The Early Knee protocol has beendefined in previous research as "children receiving an articulating prosthetic knee in their firstprosthesis (1)." The Conventional method for fitting this population is definedas "fitting children with an articulating prosthetic knee after they have learned to walkindependently with a nonarticulating knee and without the use of assistive devices." With thisprotocol, it is generally believed that children need to be 3 or 4 years of age before they canadapt to an unlocked knee condition (2); or young children should be fitted without knee jointsuntil 3 years of age (3). The secondary purposes of this survey are to determine the reasons forchoosing to follow one protocol versus the other and to determine common problems faced whentreating this population of amputees.Thank you for participating in our survey. Your feedback is very important. By completing thissurvey you will be assisting in accomplishing these purposes, which will aid in future research todetermine more effective treatment methods for infants and young toddlers. All responses willremain anonymous. If you do not wish to identify your region of practice you may skip thatquestion.

By completing the survey you are giving your consent to use your responses in this study. If forany reason during the survey, you wish to quit the survey, you may leave the survey unfinishedwithout prejudice, and your responses will be discarded from the results.

1. Geil, Crawling Kinematics in an Early Knee Protocol for Pediatric Prosthetic Prescription,JPO, Vol. 25, Num. 1, pp. 22-29, 20132. Cummings and Kapp, Lower limb Pediatric Prosthetics: General Considerations andPhilosophy, JPO, Vol. 4, Num. 4, pp. 196-206, 19923. Stanger, Orthopedic management. In: Tecklin JS, ed. Pediatric Physical Therapy, 3rd Ed., pp.387-394, 1998

1. In which Medicare region do you currently practice? A B C D

2. Approximately how many pediatric prosthetic patients requiring a prosthetic knee joint underthe age of five have you fit in your career? If your answer to this question is “0”, please exit thesurvey at this time.

0


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1-6 7-15 16-25 26 or more

3. Which fitting protocol, as defined in the cover page, do you currently follow in fittingpediatric prosthetic patients?

Conventional method (fitting children with an articulating prosthetic knee after they havelearned to walk independently with a nonarticulating knee and without the use ofassistive devices) (proceed to question 4, skip question 5)

Early Knee protocol (children receiving an articulating prosthetic knee in their first

prosthesis) (proceed to question 5, skip question 4)

I have not fit a pediatric prosthetic patient needing a prosthetic knee joint in 20 or more

years. Other (please specify)

4. Skip this question if you follow the Early Knee Protocol. What reason(s) do you have forfollowing the Conventional Protocol? Please choose one or more reason(s).

This is the way I was taught to treat this population. Increased safety for the patient. The facility I work for requires I follow this protocol. Other (please specify)

5. Skip this question if you follow the Conventional Protocol. What reason(s) do you have forfollowing the Early Knee Protocol? Please choose one or more reason(s).

Developmental benefits of an articulating knee for patients Physical benefits of an articulating knee for my patients The facility I work for requires I follow this protocol. Other (please specify)

6. Please choose the factor that most affects your decision in determining the appropriate timeto fit your patient with an articulating prosthetic knee. Please include additional factors youconsider in the blank following the choices below.

Patient can sit independently. Patient can stand independently. Patient can “sit to stand.” Patient is crawling. Patient is able to be taught how to operate the knee joint. Other (please specify)


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7. Please rate the following features of prosthetic knees that you consider when choosing a kneefor your patient from “I always consider.” to “I never consider this.” Please include additionalfeatures not listed in the “Other” box below.

Always Often Sometimes Rarely Never

Low build height Lightweight Stance flexion Manual locking Polycentric Extension assist Cost Other (please specify)

8. Please choose the prosthetic knee(s) you fit on greater than 25% of your pediatric patients.Include any knees not listed below that you fit on more than 25% of your pediatric patients in thespace provided below.

Ottobock single axis knee (3R38, 3R39) Ottobock hydraulic swing control (3R65) Ottobock polycentric with extension assist and stance flexion (3R66) Össur Total Knee Junior Fillauer Mighty Mite Fillauer MiniMac Other (please specify)

9. Please rate the following problems that you may have encountered with pediatric knees forpatients under five years old from “I always encounter this problem” to “I have neverencountered this problem.”

Always Often Sometimes Rarely Never

Poor locking mechanism Poor unlocking mechanism Build height too tall Too heavy Limited adjustability Durability Other (please specify)


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Appendix B – Email

I am a student in Baylor College of Medicine's O&P Master's Program, and I'm researching thefitting protocols of prosthetic knees on infants. If you are an ABC or BOC certified prosthetistand are willing to participate in this study, I've included a link to the survey on SurveyMonkeybelow.

Completing this survey is for research purposes only and is voluntary. You may choose at anytime during the survey to quit the survey with no consequences.

No response to this email is necessary. The researchers will have access to your responses to thesurvey through SurveyMonkey. If, however, you would like a copy of the results of this survey,you must reply to this email requesting the results. You will have until September 1 to completethis survey.

By completing this survey on Survey Monkey, you are consenting to the study. No personalinformation will be linked to your responses of this survey, and there will be no way to identifyyou through your participation in this study.

https://www.surveymonkey.com/r/V3HJ8CR

Thank you for your time,

Ashley Watkins

Baylor College of Medicine MSOP 2015

[email protected]

https://www.surveymonkey.com/r/V3HJ8CR

mailto:[email protected]


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Appendix C – IRB Protocol and Approval

Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals

Protocol Number: H-36369Status: ApprovedInitial Submit Date: 5/27/2015Approval Period: 7/16/2015 - 6/9/2016

Section Aa: Title & PI

A1. Protocol Title

A SURVEY OF PROSTHETIC KNEE FITTING PROTOCOLS FOR INFANTS IN THEUNITED STATES

A2. Principal InvestigatorName: JOSHUA B. UTAY Phone: 713-798-3098Id: 176889 Fax: 713-798-7694Department: ALLIED HEALTH Email: [email protected]

Center:MailStn:

BCM115

A3. Administrative ContactName: LIZ VETT HAECKER Phone: 713-798-3098Id: 159043 Fax: 713-798-7694

Email: [email protected]

A3a. Financial Conflict of Interest

Does the investigator have a financial interest in any non-Baylor sponsor or funding sourcefor this research?

No

Section Ab: General Information

A4. Co-Investigators

Name: ASHLEY NICOLE WATKINS Phone: 713-798-4600Id: 181862 Fax:Department: ALLIED HEALTH Email: [email protected]

Center:MailStn:

BCM368

A5. Funding Source:

Baylor College of Medicine (Internal Funding Only)


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A6a. Institutions where work will be performed:

BCM: Baylor College of Medicine

A6b. Research will be conducted outside of the United States:

Country:Facility/Institution:Contact/Investigator:Phone Number:

If documentation of assurances has not been sent to the Office of Research, please explain:

A7. Research Category:

A8. Therapeutic Intent

Does this trial have therapeutic intent?No

Section B: Exempt Request

B. Exempt From IRB Review

Not Applicable

Section C: Background

Until 1999, no research had been conducted on when to fit infants with either transfemoralamputations or congenital deficiencies with an articulating knee joint. The conventionalpractice is to fit the infant with a locked knee joint or no knee joint at all while he or shelearns to walk. There are a few reasons for this school of thought. First, the lack of anarticulating knee allows the child to learn to walk on a more stable prosthesis that will notbuckle under weight-bearing conditions. Second, there is a lack of articulating knees on themarket small enough to fit infants and small toddlers. Finally, most knees available that aresmall enough for this population are neither sufficiently durable nor do they have durablecovers. Many practitioners still abide by this conventional fitting protocol to determine whento fit their infant patients with an articulating knee. Typically, these practitioners fit infantswith a prosthesis with a locked knee joint or no knee joint when the child begins to pull to astand. Once the child has mastered walking and has reached a certain developmentalmaturity, they will then begin gait training with an articulating knee. This is usually aroundthe age of three to four years old. Research studies have since been performed supporting theneed for infants to be fit with an articulating prosthetic knee as soon as possible. The researchsupporting this fitting protocol, however, is limited, and more research is needed to supportthe early knee protocol. Many practitioners are still practicing using a traditional approach to


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fitting this unique population with prostheses and have yet to adopt this new way of practice.The earlier the patient is fit with an articulating knee joint, the more likely the child is to havenormalized gait and normal cognitive development. Also, studies have been conductedshowing the importance of crawling in the development of a child. When infants are fit with aprosthesis with either a locked knee joint or no joint at all, they are forced to crawl with adeviation that inhibits their crawling ability and can cause developmental delays byprohibiting sufficient interaction with their environment. By fitting an infant with anarticulating knee joint earlier, an infant is less hindered to develop at a normal rate and meetdevelopmental milestones than those fit with a non-articulating prosthesis.

Section D: Purpose and Objectives

The primary objective of this study is to determine the frequency at which the Early KneeProtocol is followed by prosthetists in the United States. I hypothesize that the majority ofprosthetists in the country follow a traditional protocol and do not fit infants with anarticulating knee on their first prosthesis. Secondary objectives include determining: 1) Theage or stage of development at which infants with knee disarticulations or transfemoralamputations are fit with articulating knee prostheses, 2) The reasoning behind the decision tofollow one protocol over the other, 3) Which prosthetic knee joints are most often fit, 4) Thefactors influencing the decision to fit a particular knee, and 5) Common challengesprosthetists face when fitting this population with articulating knee prostheses. Through thisstudy, I hope to find a common age at which prosthetists following the Early Knee Protocolfit their patients with an articulating knee and compare this to an age frequently cited byprosthetists as suitable when following the traditional protocol. I believe I will find there areonly a few knees that the majority of prosthetists use in the country, and these knees are mostlikely used due to a combination of durability, weight, and build height. I hope to findcommon problems faced by prosthetists fitting this patient population that have not beenaddressed through research studies or the designing of new components to solve theseproblems. This could lead to additional research to address problems that have not beenpreviously addressed by researchers.

Section E: Protocol Risks/Subjects

E1. Risk Category

Category 1: Research not involving greater than minimum risk.

E2. Subjects

Gender:Both

Age:Adult (18-64 yrs)

Ethnicity:


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All Ethnicities

Primary Language:English

Groups to be recruited will include:Healthy, non-patient, normals

Vulnerable populations to be recruited as subjects:

Vulnerable populations require special protections. How will you obtain informed consent,protect subject confidentiality, and prevent undue coercion?

E3. Pregnant woman/fetus

Will pregnant women be enrolled in the research?No

E4. Neonates

Will neonates be enrolled in the research?No

E5. Children

Will children be enrolled in the research?No

Section F: Design/Procedure

F1. Design

Select one category that most adequately describes your research:d) Questionnaire/survey/interview

Discuss the research design including but not limited to such issues as: probability of groupassignment, potential for subject to be randomized to placebo group, use of control subjects, etc.

This survey will be a convenience sample of respondents. Subjects will be recruited throughphone calls to individual facilities, and the survey will be distributed to willing subjectsthrough email. There will be no group assignments, placebo groups, or control subjects.

Inclusion Criteria:BOC or ABC certified prosthetists who have fit at least one pediatric patient under the age of5 with a transfemoral or knee-disarticulation amputation level prosthesis in their career,practice in the United States, and can communicate in English fluently.

Exclusion Criteria:


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Prosthetists who are not BOC or ABC certified, prosthetists who have not fit at least onepediatric patient under the age of 5 with a transfemoral or knee-disarticulation amputationlevel prosthesis in their career, prosthetists who do not practice in the United States, andprosthetists who cannot communicate in English fluently.

F2. Procedure

A survey has been developed by Ashley Watkins, with assistance from Joshua Utay, CPO,and Robert McLaughlin, PhD, to include questions addressing all objectives of this study.The survey will be validated through a pilot study. This will be performed by emailing a linkto the survey on Survey Monkey to prosthetists known by the investigators to be samples ofthe average prosthetist population in the United States. The survey will be distributed toprosthetists in the United States by emailing a link to the survey on Survey Monkey.Individual prosthetic facilities will be contacted by telephone and email addresses for theprosthetists in the facilities will be requested over the phone. A link to the survey on SurveyMonkey will then be sent to individual prosthetists via email. I will obtain the results of thesurveys through Survey Monkey so the answers will remain anonymous. Contact informationfor prosthetic facilities will be obtained through the ABC and ACPOC websites. Informedconsent will be addressed in the opening page of the survey. A consent form will be includedin the introduction to the survey. By completing the consent form and completing the survey,subjects will consent to their responses being used in this study. The consent procedure willbe made clear in the introduction of the survey. If respondents wish to be sent the results ofthe survey, they may request the results via a reply email to the investigator who would thenmake survey results available electronically when they have been compiled.

Section G: Sample Size/Data Analysis

G1. Sample Size

How many subjects (or specimens, or charts) will be used in this study?Local: 30 Worldwide: 30

Please indicate why you chose the sample size proposed:30 is the minimum number of respondents needed to conduct essential statistical analyses. Assuch, it is the goal to recruit at least that many, if not more. My recruitment effort will benational.

G2. Data Analysis

Provide a description of your plan for data analysis. State the types of comparisons you plan(e.g. comparison of means, comparison of proportions, regressions, analysis of variance). Whichis the PRIMARY comparison/analysis? How will the analyses proposed relate to the primarypurposes of your study?

I will perform data analysis to create visual representations, including graphs and charts, of


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the data collected. My primary comparison and analysis will be the treatment plans forinfants with knee disarticulations and transfemoral amputations by prosthetists following theEarly Knee Protocol versus prosthetists following a traditional protocol. I will also createvisual representations to show results for the most common problems faced by prosthetistswhen treating this population, and the most common factors effecting the decisionsprosthetists make when determining what age to fit these patients and which knees they fit onthis population. I will include additional visual representations of additional and unintendeddata collected. The primary analyses are descriptive. Sample Size Determination: Between 30and 100 complete and valid surveys are expected. Surveys in which the prosthetist has notseen a pediatric amputee under the age of 5 with a knee disarticulation or transfemoralamputation will be disregarded.

Section H: Potential Risks/Discomforts

H1. Potential Risks/Discomforts

Describe and assess any potential risks/discomforts and assess the likelihood and seriousness ofsuch risks:

No risks or discomforts are associated with this research.

H2. Data and safety monitoring plan

Do the study activities impart greater than minimal risk to subjects?No

H3. Coordination of information among sites for multi-site research

Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-siteresearch?

No or Not Applicable

Is BCM the COORDINATING CENTER for this multi-site research?No or Not Applicable

Section I: Potential Benefits

Describe potential benefits to be gained by the individual subject as a result of participating inthe planned work.

This study will not directly benefit the participants. Respondents who request a studysummary via email reply to the investigator sending the link to the survey results will be ableto see what practitioners across the country are doing for their patients and any problems theyare having in fitting and treating this population. They will have the opportunity to see thepros and cons of following one protocol over the other, and this may enable them to treattheir patients more effectively. If the individual completing the survey has not beenintroduced the Early Knee Protocol and the new research available, he/she will be aware of itand have a better understanding of different treatment plans for this population after


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completing the survey.

Describe potential benefits to society of the planned work.Inasmuch as participation in this survey raises awareness of novel techniques and allowsclinicians to benefit from the exchange of information, it becomes reasonable to assume thatthe average patient who could be fit under these protocols would benefit as members ofsociety.

Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.There is no risk greater than minimal associated with this research. This minimal riskinvolves recollection of difficult patients or clinical scenarios participation may bring about.Therefore, the risk-to-benefit ratio is deemed acceptable.

Section J: Consent Procedures

J1. Waiver of Consent

Will this research require a waiver of consent and authorization?No

Will additional pertinent information be provided to subjects after participation?Yes

Explain how subjects will be provided additional pertinent information after participation.Subjects who participate in the project by submitting a completed survey are given the optionof receiving the completed study by email. The respondents wishing to receive the results ofthe survey may do so by replying to the original email sent to them with the link to the surveyin Survey Monkey. No attempt will be made to associate a particular set of answers with anyrespondents.

J1a. Waiver of requirement for written documentation of Consent

Is this research subject to FDA regulations?No

Explain how the research involves no more than minimal risk to the participants, and thespecifics demonstrating that the research does not involve procedures for which written consentis normally required outside of the research context.

This research will not involve more than minimal risk to participants due to the nature of thestudy. Because this study is strictly a survey and the participants will be practitioners (novulnerable population is being studied) providing no identifying information, there will be nomore than minimal risk when participating in this study.

Explain how the only record linking the participant and the research would be the consentdocument, and how the principal risk would be potential harm resulting from a breach ofconfidentiality, and how each participant will be asked whether he or she wants documentationlinking the participant with the research and their wishes will govern.

Identifying information will not be linked with data, so the subject will be given no such


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option.

J2. Consent Procedures

Who will recruit subjects for this study?PIPI's staff

Describe how research population will be identified, recruitment procedures, and consentprocedures in detail.

The Association of Children's Prosthetic and Orthotic Clinics (or ACPOC) maintains anonline database of practices who have at least three members at the facility. With free accessto this database, practices advertised as having pediatric prosthetists will be contacted byphone. If subjects willingly agree to participate in the survey, the survey will be distributed tosubjects through email provided by subjects over the phone.

The American Board for Certification in Orthotics, Prosthetics, and Pedorthics maintains anonline database of ABC certified practitioners with credentials listed. With free access to thisdatabase, practitioners certified as prosthetists will be contacted by phone. If prosthetistswillingly agree to participate in the survey, the survey will be distributed to the subjectsthrough email provided by subjects over the phone.

A consent form will be included with the survey.

Are foreign language consent forms required for this protocol?No

J3. Privacy and Intrusiveness

Will the research involve observation or intrusion in situations where the subjects wouldnormally have an expectation of privacy?

No

J4. Children

Will children be enrolled in the research?No

J5. Neonates

Will non-viable neonates or neonates of uncertain viability be involved in research?No

J6. Consent Capacity - Adults who lack capacity

Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?No

J7. Prisoners

Will Prisoners be enrolled in the research?


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No

Section K: Confidentiality

Will research data include health information by which subjects can be identified?No

Where will research data be kept? How will such data be secured?No PHI is being collected. Data will be kept in password-protected computers on campus atBaylor College of Medicine. Respondents will provide consent through completion of thesurvey rather then signing a consent form. The data set containing the survey responses willbe destroyed once the data has been analyzed and the results of the survey are obtained.

Who, besides the PI, the study staff, the IRB and the sponsor, will have access to identifiableresearch data?

Nobody besides those listed above will have access to the data.

Will you obtain a Certificate of Confidentiality for this study?No

Please further discuss any potential confidentiality issues related to this study.NA

Section L: Cost/Payment

Delineate clinical procedures from research procedures. Will subject's insurance (or subject) beresponsible for research related costs? If so state for which items subject's insurance (or subject)will be responsible (surgery, device, drugs, etc). If appropriate, discuss the availability offinancial counseling.

There are no clinical procedures associated with this project. And, no costs or compensationare associated with this survey.

If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this researchproject, please note the total dollar amount (or dollar value amount) and distribution plan (onepayment, pro-rated payment, paid upon completion, etc) of the payment.

Dollar Amount:0

Distribution Plan:NA

Section M: Genetics


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How would you classify your genetic study?

Discuss the potential for psychological, social, and/or physical harm subsequent to participationin this research. Please discuss, considering the following areas: risks to privacy, confidentiality,insurability, employability, immigration status, paternity status, educational opportunities, orsocial stigma.

Will subjects be offered any type of genetic education or counseling, and if so, who will providethe education or counseling and under what conditions will it be provided? If there is thepossibility that a family's pedigree will be presented or published, please describe how you willprotect family member's confidentiality?

Section N: Sample Collection

None

Section O: Drug Studies

Does the research involve the use of ANY drug* or biologic? (*A drug is defined as anysubstance that is used to elicit a pharmacologic or physiologic response whether it is fortreatment or diagnostic purposes)

No

Does the research involve the use of ANY gene transfer agent for human gene transfer research?No

O1. Current Drugs

Is this study placebo-controlled?No

Will the research involve a radioactive drug that is not approved by the FDA?No

Section P: Device Studies

Does this research study involve the use of ANY device?No

Section Q. Consent Form(s)

None


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Section R: Advertisements

None

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