A randomized single-blinded trial of early rehabilitation versus immobilization after reverse total shoulder arthroplasty.
Mia S Hagen, Sachin Allahabadi, Alan L Zhang...
https://pubmed.ncbi.nlm.nih.gov/31924519Actively Recruiting
Led by The Cooper Health System · Updated on 2024-08-20
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the recovery of shoulder movement after reverse total shoulder arthroplasty in older adults with displaced proximal humerus fractures. The study compares two approaches: using a sling for comfort only with early active range of motion allowed versus placing patients in a sling for four weeks with only passive range of motion. This research aims to understand if early movement affects recovery or increases complications, as limited data exists for fracture cases. Participants are randomly assigned to one of two groups after surgery. The immobilization group wears a shoulder abduction sling for four weeks and begins gentle passive motions within set limits. After four weeks, they start active motion but avoid internal rotation until 10 weeks and strengthening until three months. The early range of motion group uses a sling for comfort but can move the arm as tolerated immediately after surgery, starting passive, active assisted, and gentle active motion except internal rotation. Both groups receive formal physical therapy and home exercise programs. Participants will be evaluated at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. Assessments include pain scores, shoulder function, range of motion, complications, and X-rays to check healing. Outcome data will be collected either in person or via email. No extra visits are required beyond standard care. The study will compare long-term recovery and complications between the two treatment approaches.
CONDITIONS
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo reverse total shoulder arthroplasty surgery for proximal humerus fractures and begin post-operative care according to their assigned group.
1 surgery day visit (in-person)
Duration - 2 years
Participants are followed up with regular evaluations to assess pain, shoulder function, range of motion, complications, and radiographs over two years.
Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years (in-person or via email for outcome scores)
Total: 1 location
1
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
P
Pietro M Gentile, BS
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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