Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06869343
Status
Recruiting
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Conditions

  • Humerus Fracture
  • Orthopedic Disorder
  • Reverse Shoulder Replacement
  • Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Physical Therapy — OTHER
    Subjects will begin physical therapy at either 2 or 6 weeks s/p a rTSA.

Study Details

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Early Onset Physical Therapy
    Patients in this arm will begin post operative physical therapy at 2 weeks after procedure.
  • Active Comparator: Delayed Onset Physical Therapy
    Patients in this arm will begin post operative physical therapy at 6 weeks after procedure.

Primary Outcome Measure

Measurement of Range of motion of shoulder Forward Flexion using a goniometer [ Time Frame: 2 week, 6 week, 3 month, and 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Medical CenterCharlottesvilleVirginia22908
Lori Elder
[email protected]
434-924-8570

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By research site
University of Virginia Medical Center· Charlottesville, VA

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