CTRI/2023/12/060688Not yet recruitingNot Applicable
Prospective multicenter study for determining the functional outcomes after surgical stabilization for unstable shoulder
Dipit Sahu3 sites in 1 country100 target enrollmentStarted: January 1, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Oxford shoulder instability score
Study Overview
Brief Summary
The study will start recruiting patients in 3 months time, the first patient will be operated as per the protocol and further consecutive patients will be enrolled after that
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 14.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Anterior shoulder instability (>1 dislocation / subluxation) < 15% anteroposterior glenoid bone loss With or without hyperlaxity.
Exclusion Criteria
- •â€¢significant shoulder comorbidities (i.e., osteoarthritis, previous shoulder surgery) •active joint or systemic infection, significant muscle paralysis, rotator cuff tears •significant medical comorbidity that may alter effectiveness of surgical intervention •psychiatric illness that precludes informed consent, •unwilling to be followed for 2 years.
Outcomes
Primary Outcomes
Oxford shoulder instability score
Time Frame: main 2-year follow-up and also at 6 months, 1-year
Rowe score
Time Frame: main 2-year follow-up and also at 6 months, 1-year
Secondary Outcomes
- Range of motion (ROM): (also 6-month & 12-month)(Recurrence of dislocation or subluxation)
Investigators
Study Sites (3)
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