Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02510625 |
| Other study ID # |
2016-035 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
Sara Sparavalo, MASc |
| Phone |
(902)473-7626 |
| Email |
research[@]drivanwong.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to investigate arthroscopic treatments of recurrent anterior
shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction
with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The
investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft
will provide better functional outcomes and decreased risk of recurrent
dislocation/subluxation.
This will be a single center, double blinded, randomized controlled trial performed in
Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario
Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation,
and range of motion. A minimum of 200 patients will be enrolled in the study as determined by
sample size calculation. Routine radiographs as well as a pre-operative CT with 3D
reconstruction and MRI are obtained for all patients. The patients will then undergo a
clinical examination and complete a variety of functional and quality of life surveys.
Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid
reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both
groups will follow a standardized rehabilitation protocol. The patient will follow-up with
the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24
month visits the patient will again undergo the structured clinical examination conducted by
a physiotherapist who is blinded to the patients' treatment group. The patient will also
complete the questionnaires at each of these follow-up appointments. Complications, and
subluxation/dislocation events will be documented at each follow-up evaluation. On the basis
of a clinical examination and patient history, the surgeon will diagnose recurrent
instability and categorize it as a traumatic or atraumatic subluxation or dislocation.
Description:
Study Objective
The objective of this study is to investigate the outcomes of arthroscopic treatments of
recurrent anterior shoulder instability. Arthroscopic bone grafting of the glenoid will be
compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize
that arthroscopic anatomic glenoid reconstruction with bone graft will provide better
functional outcomes and decreased risk of recurrent dislocation and subluxation. The null
hypothesis is that there is no difference in change in WOSI scores between arthroscopic
anatomic glenoid reconstruction and the current standard treatment, arthroscopic Bankart
repair, at two years of follow up in patients with recurrent shoulder dislocation.
Subject Selection
The objective of this study is to determine if glenoid bone grafting provides superior
functional outcomes as determined by WOSI score to Bankart repair in patients with anterior
shoulder instability. This will be a single center, double blinded, randomized controlled
trial of a minimum of 200 patients performed at the Halifax Infirmary, Queen Elizabeth II
Health Sciences Centre in Halifax, Nova Scotia, Canada. The primary outcome measured will be
WOSI score. This is a validated measure assessing quality of life in patients with this
condition. Secondary outcomes will be subluxation, re-dislocation, strength and ROM, and
other validated functional outcome scores, including: the VR-12 questionnaire, the DASH
questionnaire, and the Marx Shoulder Activity Scale (appendix). The ISIS (instability
severity index score) (appendix) score will be calculated.
The Western Ontario Shoulder Instability Index (WOSI) is a tool designed for self-assessment
of shoulder function for patients with instability problems. It is a disease specific quality
of life score. Its high sensitivity makes it able to monitor an individual patient's
progress. The WOSI score has good validity (0.768), a high degree of reliability (0.911), and
a high degree of responsiveness.
The Veterans RAND 12-Item Health Survey (VR-12) is a brief, generic, multi-use,
self-administered health survey comprised of 12 items. It has been shown to have high
internal consistency reliability (alpha > .80) and high convergent validity for EQ-5D items
(r > .56). . The instrument is primarily used to measure health-related quality of life, to
estimate disease burden, and to evaluate disease-specific benchmarks.
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical
function and symptoms in people with any of several musculoskeletal disorders of the upper
limb. DASH stands for "Disabilities of the Arm, Shoulder and Hand." In a Norweigan study
examing those with shoulder conditions the reliability was shown to be 0.93 and Construct
validity was 0.75. The tool gives clinicians and researchers the advantage of having a
single, reliable instrument that can be used to assess any or all joints in the upper
extremity.
The Marx Shoulder Activity Scale is a short, easy to administer measure of shoulder activity
used to predict outcome of shoulder disorders. The activity rating is a numerical sum of
scores for five activities rated on a five-point frequency scale from never performed (0
points) to daily (4 points). The activity scale has excellent reliability (intraclass
correlation coefficient 0.92) and construct validity (r = 0.66). It can be completed quickly
and used in conjunction with patient-based measures of shoulder outcome to define patient
populations for cohort studies, and to assess activity level as a prognostic factor in
patients with shoulder disorders.
The ISIS is a simple scoring system based on factors derived from a pre-operative
questionnaire, physical examination and AP radiographs. It may help to distinguish between
patients who will benefit from an arthroscopic anterior stabilization using suture anchors
and those who will not. It has good reliability (r>0.8). The score has high validity, as
patients with a score of six points or less have an acceptable recurrence risk of 10%, and
are therefore potentially good candidates for this procedure. By contrast, those patients
with more than six points have a recurrence risk of 70%.
Safety of both procedures will be monitored and any adverse events will be recorded.
Preoperative CT and MRI findings of bone loss will be compared with each other and also with
arthroscopic intra-operative measurements. The investigators hypothesize that arthroscopic
bone grafting of the glenoid provide superior functional outcomes as determined by WOSI score
compared to Bankart repair in patients with anterior shoulder instability.
A minimum of 200 patients will be enrolled in the study as determined by a priori sample size
calculations. The sample-size calculation was based on the mean WOSI score (85 of 100;
standard deviation [SD] = 20) from a sample of 133 patients with traumatic anterior shoulder
instability who were followed postoperatively for a minimum of one year. An estimate of
change (10% change from the mean WOSI score) was used to ensure sufficient sample size and
power. With the use of a two-sided test, an α value of 0.05, and power of 0.90, the sample
size was determined to be eighty-six patients per group. This was inflated to one hundred
patients per group to account for an estimated 16.8% loss to follow-up (this value
demonstrated in a study with Canadian patients with similar characteristics as the target
population). Each of the five surgeons participating in the study see approximately 40
patients with this pathology per year, giving an estimated recruitment time of 200 patients
in one year.
Inclusion Criteria 2 or more documented incidences of anterior glenohumeral dislocation
Exclusion Criteria Uncontrolled diabetes (Hgb A1C >7% Age 16-60 Prior surgery of affected
shoulder Pregnancy Multidirectional instability Posterior instability Paralysis of the
shoulder Cancer Severe systemic illness
Patients with recurrent anterior shoulder instability who are referred to any of the
orthopedic surgeons at Halifax Infirmary or the Dartmouth General Hospital will be initially
seen by the research coordinator, who will confirm the diagnosis and screen patients for
study eligibility. Following a detailed discussion of the risks/benefits/alternatives of the
study, the patient will be provided with a copy of the informed consent to review if they
demonstrate interest in the study. If the patient then wishes to be enrolled in the study,
the surgeon or research assistant will obtain patient consent for the study according to the
Division of Orthopaedic Surgery and Capital District Health Authority (CDHA) institutional
protocols.
Research Plan
In the pre-operative period, there will be no additional time requirements for the patient,
with the exception of the informed consent process for the study. Routine radiographs
including an AP, axillary, and Y view of the shoulder as well as a pre-operative CT with 3D
reconstruction and MRI are obtained for all patients, as is the standard of care for patients
with recurrent shoulder instability. The patient will not be exposed to any additional
radiation above the usual standard of care.
The patients will return to clinic to complete a pre-operative assessment and collection of
baseline data. Structured clinical examination will be conducted by a physiotherapist. and
consist of active and passive range of motion testing by goniometer as well as strength
testing by hand dynamometer. The patient will also complete baseline questionnaires ( WOSI
questionnaire, the VR-12 questionnaire, the DASH questionnaire, the Marx Shoulder Activity
Scale) and the ISIS score will be calculated. Any complications or events of dislocation or
subluxation will be recorded. Primary outcome will be WOSI score. Secondary outcome will be
subluxation/dislocation, and other quality of life measures and functional clinical
assessment (ROM and strength) will be assessed.
Randomization For eligible patients who meet the inclusion criteria, the research coordinator
will obtain informed consent and randomly allocate patients to one of two surgical procedure
groups: Bankart repair or Bankart repair and anatomic glenoid reconstruction with allograft
bone. Randomization will be based on surgeon skill, with one surgeon (Dr. Wong) performing
the anatomic glenoid reconstruction, and four Surgeons (Drs. Trenholm, Coady, Urquhart, &
Legay) performing Bankart repairs. Allocation will be determined through the use of
computer-generated, variable-block-size randomization and consecutively numbered opaque
envelopes. Patients will then meet the assigned surgeon, who will discuss the repair
technique in a typical clinical context, reconfirm eligibility, and address any patient
concerns regarding consent and randomization. The expertise-based randomization design
allowed the surgeons to perform their preferred surgical procedure. Two groups (Bankart
repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. After
patients have been randomized, the treating surgeon will have final decision to exclude
patient.
Surgical Technique A diagnostic arthroscopy is performed according to the method described by
Snyder (2003). The amount of glenoid bone loss and any Hill-Sachs lesions are visualized and
assessed according to a standardized protocol using a calibrated probe. This technique will
be as described by Burkhart. In his cadaveric study, he showed that the bare spot is almost
exactly in the center of the inferior glenoid, with very small standard deviations. A
calibrated probe is introduced through the posterior portal, and the distance from the bare
spot to the posterior glenoid rim is measured. The surgeon infers that the pre-dislocation
intact measurement from the bare spot to the anterior glenoid rim would have been the same as
the posterior measurement. The surgeon then uses the calibrated probe to measure the distance
from the bare spot to the anterior glenoid rim. Hill-Sachs lesions will also be measured and
documented with photography. Intraoperative photos and video will be recorded of this
technique, and the photographs will be reviewed by an independent observer. The measurement
will be quantified by the independent observer to remove any observer bias. Any bone loss is
identified, quantified, and compared with the pre-operative CT and MRI.
Bankart Repair Arthroscopic Bankart repair procedures will be performed according to each
individual surgeon's usual technique. Procedures will be performed with the patient in the
lateral or beach-chair position. Repairs for associated or conjoined superior labral
anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's
discretion. Labral detachments will be repaired with the use of suture-anchor fixation and
arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular
redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion.
Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video
of the operation will be recorded, and photographs will be taken documenting any bone loss.
Anatomic Glenoid Reconstruction The surgical technique was the lateral decubitus
all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder
instability as described by Wong et al. (In press) The procedure is done in a semi-lateral
decubitus position that assists with optimal graft placement on the native glenoid. The
investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System
(Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart
repair with one additional step. Prior to insertion of anchors, one additional medal portal
is created for insertion of the bone graft. The distal tibia allograft is prepared; the
cannulated guide is attached and advanced through the rotator interval and secured with two
cannulated screws. Finally the Bankart repair is performed above the graft. Surgical time and
video of the operation will be recorded, and photographs will be taken documenting any bone
loss.
Postoperative protocol
Patients in both groups will follow a standardized rehabilitation protocol as described by
The American Society of Shoulder and Elbow Therapists' Consensus Rehabilitation Guideline for
Arthroscopic Anterior Capsulolabral Repair of the Shoulder. Briefly, the protocol includes a
4-week period of absolute immobilization, a staged recovery of full range of motion over a
3-month period, a strengthening progression beginning at postoperative week 6, and a
functional progression for return to athletic or demanding work activities between
postoperative months 4 and 6. The patient will follow-up with the attending surgeon at 2
weeks post-operatively for a wound check. Then further follow-up appointments will be at 6
weeks, 3 months, 6 months, 12 and 24 months, as per current clinical practice.
At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical
examination conducted by a physiotherapist who is blinded to the patients' treatment group.
The patient will be wearing clothing to cover all incisions, and will be given clear
instructions to not reveal to the assessor which group they were allocated to. This will be
monitored by the research assistant. The patient will also complete the WOSI, VR-12, Marx
Shoulder Activity Scale, and DASH questionnaires at each of these follow-up appointments.
Complications, and subluxation/dislocation events will be documented at each follow-up
evaluation. On the basis of a clinical examination and patient history, the surgeon will
diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or
dislocation. Safety monitoring will be in place to document and review all adverse events.
Analysis of Data:
Two independent assessors blinded to the surgical treatment group will view the
intra-operative photos of measurement of glenoid size taken by each surgeon. The videos will
not be associated with any PHI and only identified by unique coding number. The distance from
the bare area to the anterior margin of the glenoid will be subtracted from the distance from
the bare area to the posterior margin of the glenoid. The resultant value will be identified
as the absolute anterior glenoid bone loss, and will be compared to the total diameter of the
glenoid to estimate percent of glenoid bone loss. Summary statistics for measured bone loss
will be recorded as mean +/- standard deviation, 95% confidence intervals will be calculated.
The measured bone loss will be compared to pre-operative diagnostic imaging estimates via
independent samples t-tests.
The outcome measures for each group will be reported as mean+/- standard deviation and 95%
confidence interval will be calculated. Two-Tailed T-tests will be computed for the WOSI,
VR-12, Marx Shoulder Activity Scale, and DASH scores, range of motion, and strength measures
comparing the 2 experimental groups at each time point. Repeated-measures ANOVA will be used
to perform a within-subjects analysis to assess differences in WOSI, VR-12, DASH, Marx
Shoulder Activity Scale scores, range of motion and strength within each group between time
points.
