CompletedPhase 4

Early Mobilization Following Mini-Open Rotator Cuff Repair

Canada189 participantsStarted 2003-09

Plain-language summary

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function. Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.

Who can participate

Age range

18 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: Clinical: * males and females over 18 years of age * failed non-operative management defined as persistent pain and/or disability following 3 months of conservative medical treatment including analgesic/anti-inflammatory medications, intra-articular corticosteroids, activity modification and physical therapy. Radiological: * confirmed full-thickness rotator cuff tear on arthrogram or MRI Surgical: * full-thickness tear of the rotator cuff confirmed through arthroscopy * rotator cuff repairable using mini-open approach Exclusion Criteria: * previous shoulder surgery * previous fracture of scapula or humerus * history of charcot joint or inflammatory arthropathy * cervical radiculopathy * active joint or systemic infection * neurological disorder * significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature * major medical illness (life expectancy less than 2 years or unacceptably high operative risk) * unable to speak or read English * immunosuppressive therapy or chronic steroids (eg. prednisone) * patient unwilling to be followed for 2 years * psychiatric illness that precludes informed consent

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

Change in Range of Motion (ROM)From Baseline to 24 Months

Timeframe: Baseline, 6 weeks, 3, 6, 12, 24 months

Trial details

NCT IDNCT01741272

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

Results submitted2015-02-12

View on ClinicalTrials.gov More Full Thickness Rotator Cuff Tears trials