surgical protocol - united orthopedic corporation stem... · 1106-3212 1106-3213 1106-3214. 7...

22
Surgical Protocol UTF STEM reduced TM

Upload: others

Post on 01-Aug-2020

24 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Surgical Protocol

UTF STEMreduced

TM

Page 2: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526
Page 3: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Surgical Protocol

Device Description ....................................................................................

Preoperative Planning and Templating .......................................................

Femoral Osteotomy ......................................................................................

Femoral Canal Accessing ..............................................................................

Canal Reaming ..............................................................................................

Canal Broaching ............................................................................................

Lateralization .................................................................................................

Trial Reduction ..............................................................................................

Stem Insertion ...............................................................................................

Stem Impaction .............................................................................................

Femoral Head Impaction ...............................................................................

Ordering Information

Taper Fit Stem, Reduced ..............................................................................

Femoral Head ................................................................................................

Instruments .................................................................................................

Safety Statement .........................................................................................

Table of ContentsI

1

1

2

2

3

3

3

4

5

5

6

7

8

15

Page 4: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Device Description Procedure number of total hip arthroplasty (THA) is increasing annually. Recently,

younger in the age of patient underwent THA is raised as well. The UOC introduces a specifically

designed UTF reduced stem for whole populations, which has the advantages of metaphyseal

fitting, bone preservation and simple surgical technique. UTF reduced stem characterizes

refined proximal M/L width to maximize metaphyseal fitting. Also, a slim body and

broach-only technique benefits minimal bone removal. Furthermore, the reduced distal

M/L width accommodates all kinds of femora even the proximal/distal mismatched canal.

The resected lateral shoulder and distal tip facilitates stem insertion. Standard and high

offsets are supplied for reconstruction of joint biomechanics as well. In addition, offering

unique instrumentations benefits easy-to-use, time-saving and many surgical approaches.

UTF reduced stem design and corresponded surgical devices bring the surgeons

predictable clinical outcomes and simple operations.

I

Page 5: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Preoperative planning is essential for determining the optimized stem size, neck resected level and the appropriate neck length. Making an accurate femoral component selection begins with thorough radiographic evaluation of the involved femur: a full anteroposterior (A/P) view and lateral view. The A/P radiographic image should include bilateral hip joints to help the evaluation of the affected side. These radiographies provide the estimation of leg length inequality, femoral offset, and center of rotation to reconstruct hip biomechanics.

UTF templates with 15% magnification are offered in accordance with the common enlargement of x-ray image. UTF reduced stem is designed to obtain immediate geometrical stability depended on medial and lateral cortex contact. Templating the prosthesis size which best fits the metaphyseal canal is recommended. Standard and high offset options are available for all stem sizes. High offset provides femoral lateralization, increasing stem offset while maintains leg length. Also, multiple head offsets are offered for the adjustment of neck length. The final determination of implant options should be taken into account the acetabular cup position, cup size and center of rotation of the acetabulum.

Place the Neck Resection Guide aligned with the long axis of the femoral canal. Determine the neck resection level by measuring preoperatively determined distance above the lesser trochanter or by measuring the distance from the tip of the greater trochanter to the shoulder of the stem. The cutting line can be marked by using the electrocautery, then complete the femoral neck resection with a power saw.

Preoperative Planning and Templating

FemoralOsteotomy

1

Page 6: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Canal ReamingInitiate the opening of medullary canal by the Start Reamer. For the stem size #0 and #00, the bottom groove on the Start Reamer indicates the depth of insertion, whereas the medial and the upper groove are designed as references for #1-5 and #6-14, respectively. Ensure the correct reamer alignment within the femoral shaft axis.

Utilize the modular Femoral Cutting Chisel for adequate lateral/ posterior initial entry into femoral canal. Lateralization of the canal entry is important to prevent varus alignment of prosthetic stem during insertion.

Femoral CanalAccessing

2

#6 - #14

#1 - #5#00 - #0

Page 7: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

OffsetStraight Dual-offset , Left & Right

After the opening of femoral canal, proceed broach sequence for canal preparation. The UOC provides several broach handles that fulfill different hip replacement surgical approaches. A Start Broach can be a guideline for the direction of subsequent femoral broaching. Attach the smallest UTF Broach to the proper broach handle. Start broaching procedure along the axis of the femur and maintain the appropriate orientation of the broach.Gradually enlarge the broach size until the broach contacts the medial and lateral cortices or template size is achieved. Be sure the axial and rotational stability of the final broach such that a press-fit fixation of the implant will be predicted.

Note:During canal broaching, make sure the broach is fully advanced into the canal, the most proximal part of broach should be seated in line with the neck resection surface.

Utilize the Canal Finder Rasp manually to remove bone laterally beneath the greater trochanter. This step helps to guide the axis of femur for subsequent broaching and stem implantation procedures.

Canal Broaching

3

Lateralization

Page 8: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

After trial reduction, remove the broach and introduce the stem implant by using the stem holder. The UOC offers an easily used Quick Connect Holder for stem insertion. Use the holder to firmly attach the stem via the inserting hole on the stem shoulder. Gently tap the holder to achieve initial stem implantation into medullary canal. Care should be taken to orient the stem with proper alignment and version during implant impaction.

Note: Stop tapping the holder once the stem holder impinges with greater trochanter.

Stem Insertion

Trial ReductionOnce confirming a firmly seated broach, assemble the appropriate sized standard or high offset Neck Trial onto the broach. Perform the trial reduction using the femoral head trial with desired diameter and neck length. Five sets of neck trial are offered mating with corresponding sized broach, the size 0 and 00, the size 1-4, the size 5-8, the size 9-12, and the size 13-14. Any correction of selected implant size can be made during the reassessment of leg length and joint biomechanics if required.

4

Caution : Quick Connect Holder is designed to position the implant,not for final impaction. Please impact gently to avoid instrument breakage.

Page 9: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Straight Stem Impactor Curved Stem Impactor

Use a mallet and stem impactor to further advance the stem into endosteal canal. Offered Straight and Curved Stem Impactors enable different surgical approaches. The prosthesis should be seated until most proximal portion of the coating surface is in line with the neck resection face. The interference between implant and broach is 0.5 mm per side. Mild resistance is expected during implantation. If the prosthesis could not be advanced into canal properly, remove the prosthesis and repeat the canal broaching procedure is suggested.

Note:If the stem impactor impinges with greater trochanter, any impaction may lead to bone fracture.

A final trial reduction may be performed if desired to re-evaluate stability and leg length by using the femoral head trials. After the appropriate femoral head size has been determined, place it onto the cleaned and dried taper with manual twist. Using the head impactor, engage the head with several gentle taps until it is firmly set.

Femoral HeadImpaction

Stem Impaction

5

Page 10: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Taper Fit Stem, ReducedStandard Offset

High Offset

6

Catalog Number Description

1106-30991106-30001106-30011106-30021106-30031106-30041106-30051106-30061106-30071106-30081106-30091106-30101106-30111106-30121106-30131106-3014

#00#0#1#2#3#4#5#6#7#8#9#10#11#12#13#14

#0#1#2#3#4#5#6#7#8#9#10#11#12#13#14

Catalog Number Description

1106-32001106-32011106-32021106-32031106-32041106-32051106-32061106-32071106-32081106-32091106-32101106-32111106-32121106-32131106-3214

Page 11: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

7

Femoral Head1206-11221206-13221206-15221206-1722

1206-10261206-11261206-13261206-15261206-1726

1206-10281206-11281206-12281206-14281206-16281206-1828

1206-10321206-11321206-12321206-14321206-16321206-1832

1206-10361206-11361206-12361206-14361206-16361206-1836

1203-50281203-52281203-5428

1203-50321203-52321203-54321203-5632

1203-50361203-52361203-54361203-5636

1203-50401203-52401203-54401203-5640

Ø 28 Ø 28Ø 28

Ø 32 Ø 32Ø 32Ø 32

Ø 36Ø 36Ø 36Ø 36

Ø 40Ø 40Ø 40Ø 40

- 2.5+ 1+ 4

- 3+ 1+ 5+ 8

- 3+ 1+ 5+ 9

- 3+ 1+ 5+ 9

SML

SMLXL

SMLXL

SMLXL

Ø 22Ø 22Ø 22Ø 22

Ø 26 Ø 26 Ø 26 Ø 26Ø 26

Ø 28 Ø 28Ø 28Ø 28Ø 28Ø 28

Ø 32Ø 32Ø 32Ø 32Ø 32Ø 32

Ø 36Ø 36Ø 36Ø 36Ø 36Ø 36

+ 0+ 3+ 6+ 9

- 2+ 0+ 3+ 6+ 9

- 3+ 0+ 2.5+ 5+ 7.5+ 10

- 3+ 0+ 2.5+ 5+ 7.5+ 10

- 3+ 0+ 2.5+ 5+ 7.5+ 10

Catalog Number Description (mm)U2 Femoral Head

Catalog Number Description (mm)

*BIOLOX® delta is the registry trademark of Ceramtec AG.

* The actual spherical diameter of a 22-mm metal head is 22.2 mm.

BIOLOX® deltaCeramic Head

Page 12: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

8

Instrument

9101-1302 Femoral Head Extractor

9106-2002 Neck Resection Guide

9106-3301 Start Reamer, Reduced

9106-40019106-4001-RA

Femoral Cutting Chisel (#0~#00)

UTF STEM Reduced Case #1 (9106-8310-RD)

✓ UTF STEM ReducedCase #1

UTF STEM ReducedCase #1

Catalog Number Description

Page 13: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

9

InstrumentUTF STEM Reduced Case #1 (9106-8310-RD)

✓ UTF STEM ReducedCase #1

UTF STEM ReducedCase #1

Special Order Items

Catalog Number Description

9106-53109106-53119106-53129106-53139106-5314

UTF Neck Trial, Reduced, Standard, #0 and #00UTF Neck Trial, Reduced, Standard, #1 ~ #4UTF Neck Trial, Reduced, Standard, #5 ~ #8UTF Neck Trial, Reduced, Standard, #9 ~ #12UTF Neck Trial, Reduced, Standard, #13 and #14

9106-53209106-53219106-53229106-53239106-5324

UTF Neck Trial, Reduced, High Offset, #0UTF Neck Trial, Reduced, High Offset, #1 ~ #4UTF Neck Trial, Reduced, High Offset, #5 ~ #8UTF Neck Trial, Reduced, High Offset, #9 ~ #12UTF Neck Trial, Reduced, High Offset, #13 and #14

9106-6101 Canal Finder Rasp

9106-63999106-63009106-63019106-63029106-63039106-63049106-63059106-63069106-63079106-63089106-63099106-63109106-63119106-63129106-63139106-6314

UTF Broach, Reduced, #00UTF Broach, Reduced, #0UTF Broach, Reduced, #1UTF Broach, Reduced, #2UTF Broach, Reduced, #3UTF Broach, Reduced, #4UTF Broach, Reduced, #5UTF Broach, Reduced, #6UTF Broach, Reduced, #7UTF Broach, Reduced, #8UTF Broach, Reduced, #9UTF Broach, Reduced, #10UTF Broach, Reduced, #11UTF Broach, Reduced, #12UTF Broach, Reduced, #13UTF Broach, Reduced, #14

9106-6000 Start Broach

* The size of UTF Broach, Reduced, is 0.5 mm smaller per side than the implant at M/L dimension.

Page 14: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

10

9106-6399-RA9106-6300-RA9106-6301-RA9106-6302-RA9106-6303-RA9106-6304-RA9106-6305-RA9106-6306-RA9106-6307-RA9106-6308-RA9106-6309-RA9106-6310-RA9106-6311-RA9106-6312-RA9106-6313-RA9106-6314-RA

UTF Broach, Reduced, ML 0mm, #00 (line to line)UTF Broach, Reduced, ML 0mm, #0 (line to line)UTF Broach, Reduced, ML 0mm, #1 (line to line)UTF Broach, Reduced, ML 0mm, #2 (line to line)UTF Broach, Reduced, ML 0mm, #3 (line to line)UTF Broach, Reduced, ML 0mm, #4 (line to line)UTF Broach, Reduced, ML 0mm, #5 (line to line)UTF Broach, Reduced, ML 0mm, #6 (line to line)UTF Broach, Reduced, ML 0mm, #7 (line to line)UTF Broach, Reduced, ML 0mm, #8 (line to line)UTF Broach, Reduced, ML 0mm, #9 (line to line)UTF Broach, Reduced, ML 0mm, #10 (line to line)UTF Broach, Reduced, ML 0mm, #11 (line to line)UTF Broach, Reduced, ML 0mm, #12 (line to line)UTF Broach, Reduced, ML 0mm, #13 (line to line)UTF Broach, Reduced, ML 0mm, #14 (line to line)

9401-7012 Caliper

InstrumentUTF STEM Reduced Case #1 (9106-8310-RD)

✓ UTF STEM ReducedCase #1

UTF STEM ReducedCase #1

Special Order Items

Catalog Number Description

*The size of UTF Broach, Reduced, ML 0mm is the same as the implant at M/L dimension.

Page 15: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

11

InstrumentUTF STEM Reduced Case #1 (9106-8310-RD)

✓UTF STEM ReducedCase #1

UTF STEM ReducedCase #1

Catalog Number Description (mm)

Catalog Number Description (mm)

1206-2122-RB1206-2322-RB1206-2522-RB1206-2722-RB

1206-2026-RB1206-2126-RB1206-2326-RB1206-2526-RB1206-2726-RB

1206-2028-RB1206-2128-RB1206-2228-RB1206-2428-RB1206-2628-RB1206-2828-RB

1206-2032-RB1206-2132-RB1206-2232-RB1206-2432-RB1206-2632-RB1206-2832-RB

1206-2036-RB1206-2136-RB1206-2236-RB1206-2436-RB1206-2636-RB1206-2836-RB

1203-6028-RB1203-6228-RB1203-6428-RB

1203-6032-RB1203-6232-RB1203-6432-RB1203-6632-RB

1203-6036-RB1203-6236-RB1203-6436-RB1203-6636-RB

1203-6040-RB1203-6240-RB1203-6440-RB1203-6640-RB

Ø 22Ø 22Ø 22Ø 22

Ø 26Ø 26Ø 26Ø 26Ø 26

Ø 28Ø 28Ø 28Ø 28Ø 28Ø 28

Ø 32Ø 32Ø 32Ø 32Ø 32Ø 32

Ø 36Ø 36Ø 36Ø 36Ø 36Ø 36

+ 0+ 3+ 6+ 9

- 2+ 0+ 3+ 6+ 9

- 3+ 0+ 2.5+ 5+ 7.5+ 10

- 3+ 0+ 2.5+ 5+ 7.5+ 10

- 3+ 0+ 2.5+ 5+ 7.5+ 10

Ø 28Ø 28Ø 28 Ø 32Ø 32Ø 32Ø 32

Ø 36Ø 36Ø 36 Ø 36

Ø 40 Ø 40 Ø 40 Ø 40

- 2.5+ 1+ 4

- 3+ 1+ 5+ 8

- 3+ 1+ 5+ 9

- 3+ 1+ 5+ 9

SML

SMLXL

SMLXL

SMLXL

U2 Femoral Head Trial

*BIOLOX® delta is the registry trademark of Ceramtec AG.

BIOLOX® deltaCeramic Head Trial

Page 16: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

12

InstrumentUTF STEM Reduced Case #1 (9106-8310-RD)

✓UTF STEM ReducedCase #1

UTF STEM ReducedCase #1

9104-9001-RA Femoral Head Remover

9106-1311 UTF Stem, Reduced, Quick Connect Holder

9204-1226-RA Femoral Head Impactor

9206-1110 Universal Handle

Catalog Number Description

Page 17: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

13

UTF STEM Reduced Case #2 (9106-8320)

UTF STEM ReducedCase #2

Instrument

9106-1005 Anteversion Handle

9106-1106-RC Straight Stem Impactor

9106-1107-RC Curved Stem Impactor

9106-1101 Straight Broach Handle

9106-1301 Offset Broach Handle

Catalog Number Description

Page 18: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

14

UTF STEM Reduced Case #2 (9106-8320)

UTF STEM ReducedCase #2

Catalog Number Description

Instrument

9106-5001 Hammer

UTF STEM Reduced Case #3 (9106-8030)

UTF STEM ReducedCase #3

Catalog Number Description

Instrument

9106-15019106-1502

Dual-offset Broach Handle, LeftDual-offset Broach Handle, Right

9106-5003 Stem Extractor Wrench

9106-5101 Slide Hammer Rod

9106-5302 UTF Stem, Reduced, Extractor, M6

Page 19: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

INDICATIONSThis device is indicated for use in total hip replacement or bipolar hip replacement undergoing

primary and revision surgery for the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis,

ankylosis, protrusion acetabuli, and painful hip dysplasia.

2. Inflammatory degenerative joint disease such as rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur

with head involvement, unmanageable using other techniques.

5. Revision procedures where other treatments or devices have failed.

6. This device is designed for cementless use.

Safety Statement

15

Please refer to the product-specific package inserts for important information, including indications, contraindications, warnings, precautions, and potential adverse effects.For Reprocessing Instructions for Reusable Surgical Instruments, please follow the route at www.uoc.com.tw >> Medical Professional >> Download >> Others.

Page 20: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526
Page 21: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526
Page 22: Surgical Protocol - United Orthopedic Corporation Stem... · 1106-3212 1106-3213 1106-3214. 7 Femoral Head 1206-1122 1206-1322 1206-1522 1206-1722 1206-1026 1206-1126 1206-1326 1206-1526

Each Step We Care

UOC-UM-UN-00010 Rev.1 JUN. 2018Copyright © 2018 United Orthopedic Corp.

www.uoc.com.tw

■ TaiwanUnited Orthopedic Corporation12F, No.80, Sec.1, Chenggong Rd., Yonghe Dist., New Taipei City 23452, TaiwanTel: +886 2 2929 4567 Fax: +886 2 2922 4567

■ ChinaUnited Medical Instrument Co., Ltd.Room 402, Building 7, No.697, Ling Shi Road, ShangHai 200072, ChinaTel: +86 21 3661 8055 Fax: +86 21 6628 3031

■ JapanUnited Biomech Japan Inc.Ginyo Bldg 4th floor, 2-9-40 Kitasaiwai, Nishi-Ku Yokohama City, Kanagawa, 220-0004, JapanTel: +81 45 620 0741 Fax: +81 45 620 0742

■ USAUOC USA Inc.20, Fairbanks, Suite 173, Irvine 92618, CATel: +1 949 328 3366 Fax: +1 949 328 3367

■ EU Representativemdi Europa GmbHLangenhagener Strasse 71, Langenhagen 30855 , GermanyTel: +49 511 3908 9530 Fax: +49 511 3908 9539

■ EuropeUOC (Suisse) SAAvenue Général Guisan 60A, Pully 1009, SwitzerlandTel: +41 21 634 70 70 Fax: +41 21 634 70 76UOC (France)21, Rue de la Ravinelle, Nancy 54000, FranceTel: +33 3 83 23 39 72 Fax: +33 3 83 23 39 10

Contact Us