Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humeru… (NCT06869343) | Clinical Trial Compass
RecruitingNot Applicable
Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture
United States10 participantsStarted 2025-05-19
Plain-language summary
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.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged 50-85 undergo reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures
Exclusion Criteria:
* previous rTSA to ipsilateral shoulder
* undergoing elective rTSA
* Prisoners
* unwilling to be randomized
* unwilling or unable to attend follow up visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing early versus delayed rehabilitation after reverse total shoulder replacement for a humerus fracture — can you explain what 'early' versus 'delayed' means in this context, and which approach you currently recommend for my situation?
2Since the trial is measuring shoulder forward flexion as the main outcome, how important is regaining that specific range of motion for the daily activities I care most about, and does that align with my personal recovery goals?
3This study is listed as Phase NA, which often means it's comparing two existing rehabilitation approaches rather than testing a new drug or device — does that change the risk profile compared to my standard post-surgery rehab plan, and what would I be giving up or gaining by participating?
4How would being randomly assigned to either the early or delayed rehabilitation group affect my recovery timeline practically — for example, how soon after surgery would I start physical therapy in each group, and could either schedule cause problems given my home situation or support system?
5Given that this trial is actively recruiting, are there other ongoing studies or standard-of-care protocols for rehab after reverse shoulder replacement that I should also consider before deciding whether this trial is the right path for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of Range of motion of shoulder Forward Flexion using a goniometer