Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17-50
SponsorUniversity of Pittsburgh
About this trial
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss. The results of the study assist in optimizing time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. This study will provide a critical clinical advancement of a previously unaddressed and common clinical scenario.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Civilians and military personnel ages 17 to 50
Traumatic anterior shoulder dislocation
Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan
Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet
Disqualifiers
Chronic, non-traumatic multi-directional instability based on clinical exam
Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2)
Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet [previous isolated arthroscopic Bankart repair only would not be an exclusion criterion], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)
Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery
Trial population
Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Arthroscopic Bankart repair procedure
Procedure/SurgeryBankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
Open Bankart
Procedure/SurgeryOpen Bankart repair consists of anterior capsulorrhaphy with labral repair.
Latarjet
Procedure/SurgeryLatarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
Post-Operative Rehabilitation
Other interventionPost-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation2 interventions
Group B: Open Bankart/rehabilitation2 interventions
Group C: Latarjet/rehabilitation2 interventions
Trial outcomes
Primary outcomes
1
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time frame
3 months after surgery2
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time frame
6 months after surgery3
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time frame
12 months after surgery4
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Time frame
24 months after surgerySecondary outcomes
1
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time frame
3 months after surgery2
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time frame
6 months after surgery3
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time frame
12 months after surgery4
Single Assessment Numerical Evaluation (SANE)
The SANE is a single-item, global, patient-reported outcome measure, where the participant provides a whole number response to the question "On a scale from 0 to 100, how would you rate your injured shoulder today, with 100 being normal?" SANE scale reliability is excellent (ICC greater or equal to 0.80) and Standard Error of Measurement ranges from 4.23 to 7.82 points. Validity of the SANE displays correlations of 0.50 - 0.88 (moderate to very strong correlations) between the SANE scale and other partient-reported outcome measures.
Time frame
24 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov