Phase 4 N=189 Randomized Single-blind Treatment

Early Mobilization Following Mini-Open Rotator Cuff Repair

Full Thickness Rotator Cuff Tears

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View on ClinicalTrials.gov: NCT01741272 ↗

Enrolled (actual)

189

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Change in Range of Motion (ROM)From Baseline to 24 Months — 124.4; 120.2; 73.2; 84.1 degrees

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sling (Procedure); No sling (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Range of Motion (ROM)From Baseline to 24 Months	124.4; 120.2; 73.2; 84.1; 118.5; 120.0	—
SECONDARY Pain Questionnaire	4.0; 4.0; 2.3; 2.4; 1.3; 1.4	—
SECONDARY WORC Questionnaire	40.1; 40.1; 90.9; 89.4	—
SECONDARY Abduction Strength Using the Power Component of the Constant Score	8.7; 8.3; 16.5; 16.3	—
SECONDARY Complications	20; 17	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01741272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.