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 range18 Years – 85 Years

SexALL

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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

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