no orthosis is equivalent to tlso for the treatment of thoracolumbar burst fractures without...
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![Page 1: No Orthosis is Equivalent to TLSO for the Treatment of Thoracolumbar Burst Fractures without Neurologic Injury: Results from a Multicenter RCT](https://reader037.vdocuments.mx/reader037/viewer/2022100402/575084d91a28abf34fb21df1/html5/thumbnails/1.jpg)
The Spine Journal 11 (2011) 1S–173S
NASS 26th Annual Meeting – Proceedings
Wednesday, November 2, 20111:10–2:10 PM
General Session: Best Papers
1. Functional and Quality of Life Outcomes in Geriatric Patients
with Type II Odontoid Fracture: One-Year Results from the
AOSpine North America Multicenter GOF Prospective Study
Branko Kopjar, MD, PhD1, Alexander Vaccaro, MD, PhD2,
Michael Fehlings, MD, PhD, FRCSC3, Jens Chapman, MD4,
Christopher Shaffrey, MD5, Paul Arnold, MD6,
Ziya Gokaslan, MD, FACS7, Roger Hartl, MD8, Darrel Brodke, MD9,
John France, MD10, S. Tim Yoon, MD, PhD11, Mark Dekutoski, MD12,
Rick Sasso, MD13, Christopher Bono, MD14; 1University of Washington,
Seattle, WA, USA; 2Rothman Institute, Philadelphia, PA, USA; 3Toronto
Western Hospital, Toronto, ON, Canada; 4UW Harborview Medical
Center, Seattle, WA, USA; 5University of Virginia Department of
Neurosurgery, Charlottesville, VA, USA; 6University of Kansas Medical
Center, Department of Neurosurgery, Kansas City, KS, USA;7Johns Hopkins University, Department of Neurosurgery, Baltimore, MD,
USA; 8NY Presbyterian Hospital - Weill Cornell, New York, NY, USA;9University Orthopaedic Center, Salt Lake City, UT, USA; 10Robert C.
Byrd Health Sciences Center, Morgantown, WV, USA; 11The Emory Spine
Center, Atlanta, GA, USA; 12Mayo Clinic, Rochester, MN, USA; 13Indiana
Spine Group, Indianapolis, IN, USA; 14Brigham & Women’s Hospital,
Department of Orthopedic Surgery, Boston, MA, USA
BACKGROUND CONTEXT: Type II odontoid fractures are common in
the elderly and represent a major management challenge, with diverging
opinions of risks/benefits of surgical vs. nonoperative management. This
lack of consensus among clinicians as to the optimal management strategy
for geriatric odontoid fractures is exacerbated bythe paucity of objective,
prospective information regarding treatment outcomes in this condition.
Hence, better evidence related to treatment efficacy and safety is warranted
to inform management decisions regarding elderly patients who present
with an odontoid fracture.
PURPOSE: To evaluate treatment efficacy and safety of surgical vs.
nonoperative management within elderly patients who present with an
odontoid fracture.
STUDY DESIGN/SETTING: We conducted a prospective multi-center
cohort study of subjects O65 yrs old with a type II odontoid fracture at
13 sites in North America.
PATIENT SAMPLE: A total of 166 subjects presenting with an odontoid
fracture were recruited between January 2006 and May 2009.
OUTCOME MEASURES: Outcomes assessments included the SF36v2,
Neck Disability Index (NDI) and rates of mortality and complications.
METHODS: Patients received nonoperative or surgical treatment at the
discretion of the surgical team and were followed for 12 months.
RESULTS: The average age was 80.7 (SD 7.6) with a range from 65
to 101 years. 59.6% were females. 65.6% patients were treated oper-
atively (15.2% anterior odontoid screw; 76.2% posterior C1- C2 screw
fixation; 6.7% posterior transarticular screw fixation and 1.9% other)
and 34.4% with conservative approaches. A total of 26 (15.7%) sub-
jects expired and 5 subjects withdrew from the study. Baseline NDI
and SF-36v2 values were based on estimate of pre-injury status. The
baseline NDI was 20.5 (SD 16.7) and the 12-month NDI was 28.3
(SD 20.1) (p!.01). SF36v2 PCS at baseline was 41.8 (SD 10.05)
All referenced figures and tables will be available at the Annual Mee
and at 12-month 39.4 (SD 10.1) (p5.03). SF36v2 MCS at baseline
was 52.48 (SD 10.3) and at 12-month 48.1 (SD 11.9) (p!.01). There
were no differences in age and gender between the surgically and con-
servatively treated subjects. Mortality was similar in the surgical and
nonoperative groups. SF36v2 PCS outcomes were similar between the
two treatment groups but the SF36v2 MCS outcomes were better in
the surgical group as compared to the cohort of patients managed non-
operatively (49.8 and 45.2 in surgical and conservative groups, respec-
tively, p5.05). Moreover, functional outcomes as measured by NDI
were significantly better in the operative than the nonoperative group.
After adjustment for baseline characteristics, the 12-month NDI was
34.1 in the nonoperatively-managed group as compared to 25.1 in
the operative group (p!.01).
CONCLUSIONS: Elderly patients with type II odontoid fracture experi-
ence significant mortality which is probably due to advanced age and gen-
erally compromised health status. However, the vast majority of patients
(85% in our study) survive 12 months following the initial injury. Our re-
sults do suggest that functional and quality of life outcomes may be better
in the surgical group, though the possibility of selection bias needs to be
carefully considered.. Judgment is required by the treating team when
selecting the optimal management strategy for the elderly with Type II
odontoid fractures. In good risk, highly functioning patients, we recom-
mend an operative approach. In poor risk, medically compromised individ-
uals, a nonoperative approach to type II odontoid fractures is safe and
clinically reasonable.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.016
2. No Orthosis is Equivalent to TLSO for the Treatment of
Thoracolumbar Burst Fractures without Neurologic Injury: Results
from a Multicenter RCT
Christopher Bailey, MD, FRCSC1, Marcel Dvorak, MD, FRCSC2,
Melissa Nadeau, MD3, Allan Aludino4, M. Patricia Rosas-Arellano, MD3,
Michael Boyd, MD2, Scott Paquette, MD5,
Brian K. Kwon, MD, PhD, FRCSC2, John France, MD6,
Kevin R. Gurr, MD7, Stewart Bailey, MD3, Charles Fisher, MD6;1University of West Ontario London Health Sciences Centre, London, ON,
Canada; 2Blusson Spinal Cord Centre, Vancouver, BC, Canada; 3London,
ON, Canada; 4University of British Columbia, Vancouver, BC, Canada;5Vancouver, BC, Canada; 6Robert C. Byrd Health Sciences Center,
Morgantown, WV, USA; 7London Health Sciences Centre, London, ON,
Canada
BACKGROUND CONTEXT: Thoracolumbar burst fractures are com-
mon injuries. Good outcomes can be expected for those patients presenting
without neurologic injury who are treated with a thoracolumbosacral or-
thosis (TLSO) and early ambulation. However, anecdotal experience and
low grade evidence suggest these fractures may be satisfactorily treated
without a brace.
PURPOSE: To compare the functional outcome of patients with AO type
A3 burst fractures randomly treated with a TLSO versus no orthosis (NO).
STUDY DESIGN/SETTING: A multi-centred prospective randomized
controlled equivalence trial.
PATIENT SAMPLE: Patients were recruited from three Canadian tertiary
spine centres.
ting and will be included with the post-meeting online content.
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2S Proceedings of the NASS 26th Annual Meeting / The Spine Journal 11 (2011) 1S–173S
OUTCOME MEASURES: The primary outcome measure was the Ro-
land Morris Disability Questionnaire (RMDQ) assessed at 3 months post
injury. Secondary outcomes were assessed at 2 and 6 weeks, 3, 6, 12
and 24 months and included: pain (Visual Analogue Scale), functional out-
come (RMDQ), generic health related quality of life (SF-36), patient sat-
isfaction, sagittal alignment, length of hospital stay and complications.
METHODS: Consecutive patients who satisfied the following inclusion
criteria were considered eligible for this study: 1) AO-A3 burst fractures
between T11 and L3, 2) skeletally mature and less than sixty years of
age, 3) admitted to the participating hospital within seventy-two hours
of their injury, 4) initial kyphotic deformity of less then thirty-five degrees,
5) no neurologic deficit. Randomization was stratified according to
worker’s compensation status and severity of kyphosis at admission
(!20� versus $20�). Enrollment continued until the sample size satisfied
a power of 90%. The NO group was encouraged to ambulate immediately
following randomization with bending restrictions for eight weeks. The
TLSO group was weaned from the brace between the eight to ten week pe-
riod. Both groups were encouraged to perform a standardized physiother-
apy routine.
RESULTS: 47 patients were enrolled into the TLSO group and 49 patients
into the NO group. The mean subject age was 40 years and 70% were
male. The majority of fractures occurred at L1 (49) then T12 (18) and
L2 (15). At the three month primary endpoint 46 patients were evaluated
in each group. This declined to 36 patients followed in each group at 2
years. There was no difference in average length of hospital stay
(TLSO54.7 days, NO55.0 days). No difference was found between
groups for any of the primary or secondary outcomes at any of the fol-
low-up periods (student t-test). One way analysis of variance identified
a significant improvement of the RMDQ within both groups at 6 weeks
(p!.05) (figure). The average kyphotic deformity was 14� (range: �1 to
35) at admission that increased to 21� at 6 weeks and did not progress fur-
ther. No difference in average kyphotic deformity existed between treat-
ment groups. Six patients required surgical stabilization, five of these
prior to initial hospital discharge.
CONCLUSIONS: Neurologically intact thoracolumbar burst fractures can
be successfully treated using early ambulation without a brace.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.017
3. Incidence and Impact of Acute Adverse Events in Patients with
Traumatic Spinal Cord Injury
Antoinette Cheung1, John Street, PhD2, Vanessa Noonan, PT2,
Lydia Cartar1, Marcel Dvorak, MD, FRCSC3; 1Rick Hansen Institute,
Vancouver, BC, Canada; 2Vancouver, BC, Canada; 3Blusson Spinal Cord
Centre, Vancouver, BC, Canada
BACKGROUND CONTEXT: Adverse events with significant resultant
morbidity are common during the acute hospital care of patients with trau-
matic spinal cord injury (TSCI). The Rick Hansen SCI Registry (RHSCIR)
collects Canada wide data on patients with TSCI; data such as sociodemo-
graphic, injury, diagnosis, intervention, and health outcome details. This
data contributes to an evidence base for informing best practice and im-
proving SCI care. As the RHSCIR captures data on patients from pre-hos-
pital to community phases of care, it is an invaluable resource for
providing information on health outcomes resulting from TSCI, including
outcomes related to adverse events.
PURPOSE: To determine the incidence and types of adverse events occur-
ring in patients with TSCI during acute care and the impact on length of
stay (LOS) and health status.
STUDY DESIGN/SETTING: Prospective cohort study at an academic
quaternary referral centre.
PATIENT SAMPLE: Patients with TSCI discharged from Vancouver
General Hospital between 2008-2009 were identified using the RHSCIR.
All referenced figures and tables will be available at the Annual Mee
The RHSCIR includes patients of any age admitted to one of the partici-
pating centres across Canada, who have been clinically diagnosed with
an acute TSCI or classified as AIS A, B, C, D, or cauda equina.
OUTCOME MEASURES: Acute phase LOS and health status were as-
sessed for impact resulting from the number and type of adverse events ex-
perienced. Health status was determined using the Short-Form 36 (SF-36)
Physical and Mental Component Scores (PCS and MCS, respectively).
METHODS: Data related to patients’ injury, diagnoses, hospital admis-
sion, and SF-36 scores was obtained from the Vancouver RHSCIR. Data
on intra-, pre-, and post-operative adverse events was collected prospec-
tively using the Spine Adverse Events Severity (SAVES) data collection
system, documenting all adverse events experienced by each patient. Mul-
tivariate analyses were performed to determine whether patient and injury
characteristics were associated with number and type of adverse events ex-
perienced, and whether these were associated with LOS and SF-36 scores
determined upon follow-up.
RESULTS: 110 patients with TSCI were included, 78.2% were male and
mean age at injury was 45.8619.6 years. Follow-up ranged from 11-27
months post-injury. Adverse events occurred in 83.6% of patients;
20.0% experienced an intra-operative and 79.1% experienced a pre-/
post-operative event. The most frequent pre-/post-operative adverse events
were urinary tract infections (UTIs) (36.5%), pneumonias (34.6%), neuro-
pathic pain (22.1%), pressure sores (19.2%) and delirium (18.3%). LOS
was significantly impacted by pressure sores, delirium, pneumonias and
UTIs (p!.01), increasing 1.8 (UTIs) to 2.2 (pressure sores) times com-
pared to patients without the specific adverse events. SF-36 MCS was sig-
nificantly reduced in patients with UTIs (p!.05), indicating lower health
status.
CONCLUSIONS: This prospective study found that more than 83% of
patients with TSCI sustain an adverse event during acute hospital care, sig-
nificantly higher than previously reported. We demonstrate the utility of
a dedicated adverse event collection system and the effect of these events
on health status.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2011.08.018
4. Preclinical Study of Human Allograft Amniotic Membrane as
a Barrier to Epidural Fibrosis in the Early Wound of
a Postlaminectomy Rat Model
Andrew Mahar1, R. Todd Allen2, Jennifer Massie3, Frank Phillips, MD4;1Alphatec Spine, Inc., Carlsbad, CA, USA; 2University of California San
Diego, San Diego, CA, USA; 3VA Medical Center, San Diego, CA, USA;4Midwest Orthopaedics at Rush, Chicago, IL, USA
BACKGROUND CONTEXT: After lumbar spine surgery, epidural scar-
ring is thought to compromise clinical results and makes revision surgery
more challenging. Barriers that limit the adherence of scar to the dura, and
reduce post-operative neuropathic pain, are desirable. Amniotic membrane
is known to prevent scar formation, and has been used for ulcerative and
burn wound healing making it a potential candidate material for reducing
post-laminectomy scarring.
PURPOSE: The purpose of the current study is to evaluate the use of hu-
man amniotic membrane for prevention of dural adhesions in a well-estab-
lished post-laminectomy animal model.
STUDY DESIGN/SETTING: In vivo animal survival study.
PATIENT SAMPLE: 32 mature male rats.
OUTCOME MEASURES: histology, biomehcanics, pain thresholds
METHODS: Thirty two mature male Harlan Sprague–Dawley rats had bi-
lateral laminectomies (L5 and L6) and a right unilateral ‘‘joystick’’ disc
injury (L5–6). Rats were then randomly assigned to receive human amni-
otic roofing barrier (Amnioshield�, Alphatec Spine, Carlsbad, CA) over
the laminectomy site or no barrier treatment (control). Animals survived
for 8 weeks. For each group, 8 animals were dedicated to histological
ting and will be included with the post-meeting online content.