Actively Recruiting
Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture A Randomized Controlled Trial
Led by University of Virginia · Updated on 2025-05-30
10
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
F
Foundation of Orthopedic Trauma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the best timing for rehabilitation after reverse total shoulder arthroplasty (rTSA) in patients aged 50 to 85 who have suffered proximal humerus fractures. This study aims to determine whether starting physical therapy early or delaying it affects shoulder motion, patient-reported outcomes, and postoperative complications. The goal is to improve recovery protocols for this patient group, as current practices vary widely. Participants will be randomly assigned to one of two groups: one begins physical therapy two weeks after surgery (early rehabilitation), and the other starts six weeks after surgery (delayed rehabilitation). Both groups will follow their assigned rehabilitation schedule postoperatively. The study includes in-person clinic visits and radiographic evaluations at six weeks, three months, and six months after surgery to monitor progress and safety. Throughout the study, participants will undergo range of motion measurements using a goniometer and complete patient-reported outcome assessments such as the American Shoulder Elbow Surgeons Shoulder Score and Constant score. Researchers will also review medical charts and radiographs to track any postoperative complications. The total follow-up period spans six months, allowing for detailed monitoring of recovery and functional outcomes.
CONDITIONS
Brief Title
Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 to 85 years
- Undergoing reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures
You will not qualify if you...
- Previous reverse Total Shoulder Arthroplasty to the same shoulder
- Undergoing elective reverse Total Shoulder Arthroplasty
- Prisoners
- Unwilling to be randomized
- Unwilling or unable to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo reverse total shoulder arthroplasty for proximal humerus fracture and receive immediate post-operative care.
1 visit (in-person)
Duration - Up to 6 months post-surgery
Participants begin physical therapy either early at 2 weeks or delayed at 6 weeks after surgery to improve shoulder function.
In-person clinic visits with radiographs at 6 weeks, 3 months, and 6 months postoperatively
Duration - Up to 6 months post-surgery
Participants are monitored for postoperative complications and functional outcomes during follow-up visits.
In-person clinic visits with radiographs at 6 weeks, 3 months, and 6 months postoperatively
Trial Site Locations
Total: 1 location
1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
L
Lori Elder
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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