CompletedNot Applicable

Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

United States90 participantsStarted 2018-01-29

Plain-language summary

The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.

Who can participate

Age range

61 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

. Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
. A pre-operative plan for RTSA
. Age \>60

Exclusion criteria

. Active infection
. Incompetent deltoid muscle
. Unwillingness or inability to participate in a home exercise program
. Medically unfit for operative intervention

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Range of Motion Outcomes

Timeframe: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively

Trial details

NCT IDNCT03430167

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-12

View on ClinicalTrials.gov More Shoulder Arthropathy Associated With Other Conditions trials