Conservative Versus Operative - First Time Shoulder Dislocations
ConditionShoulder Dislocation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorColumbia University
About this trial
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
patients 12 and older
seen by the Columbia University Shoulder Elbow and Sports Medicine Service
first time anterior shoulder dislocation diagnosis
Disqualifiers
humeral avulsion during arthroscopy
bony defect > 25% of glenoid surface
general anesthesia contraindication
previous shoulder surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Arthroscopic Bankart repair
Procedure/SurgeryParticipants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
Physical therapy
Procedure/SurgeryParticipants in this group will follow a specific physical therapy rehabilitation protocol
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Operative groupExperimental treatment 1 intervention
Group B: Non-operative groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Western-Ontario Shoulder instability Index Score at 2 weeks
A questionnaire ranging from 0 to 2100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time frame
Baseline and 2 weeks2
Change in Patient Reported Outcome Measure Information System (PROMIS) Physical function (PF) Computer Adaptive Test (CAT) at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time frame
Baseline and 2 weeks3
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time frame
Baseline and 2 weeks4
Change in PROMIS Depression CAT at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their shoulder injury. A lower score indicates a better outcome.
Time frame
Baseline and 2 weeksSecondary outcomes
1
Change in Constant-Murley Score at 2 weeks
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time frame
Baseline and 2 weeks2
Change in Constant-Murley Score at 6 weeks
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time frame
Baseline and 6 weeks3
Change in Constant-Murley Score at 3 months
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time frame
Baseline and 3 months4
Change in Constant-Murley Score at 6 months
The Constant-Murley Score is a questionnaire that ranges from 0 (worst shoulder function) to 100 (best shoulder function) points that asks questions related to functional status and pain in the context of shoulder injuries.
Time frame
Baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: