Overview

This trial is active, not recruiting.

Condition full thickness rotator cuff tears
Treatments sling, no sling
Phase phase 4
Sponsor Shoulder & Upper Extremity Research Group of Edmonton
Start date September 2003
End date April 2013
Trial size 190 participants
Trial identifier NCT01741272, Pro00001096

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
sling
Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
(Experimental)
Will use the sling for comfort only. Intervention: Procedure: No sling
no sling
Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.

Primary Outcomes

Measure
Change in Range of Motion (ROM)from baseline to 24 months
time frame: Baseline, 6 weeks, 3, 6, 12, 24 months

Secondary Outcomes

Measure
pain questionnaire
time frame: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months
WORC questionnaire
time frame: Baseline, 6, 12, 24 months
ASES questionnaire
time frame: Baseline, 6, 12, 24 months
Constant Score
time frame: Baseline, 6, 12, 24 months
Complications
time frame: 2 & 6 weeks, 3, 6, 12, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial
Principal investigator Robert Balyk, MD, FRCSC
Description The rotator cuff is a group of four muscles around the shoulder. They function to provide both shoulder mobility and power as well as stability. Rotator cuff tears can be a significant cause of pain and disability for the patient. Surgical repair is done to reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease pain, increase range of motion(ROM) and strength. This is done with a small incision called a mini-open. Standard care following this surgical repair is to be placed in a sling for 6 weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using the non-operated arm for assistance. No active or voluntary movement is allowed during the first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows their recovery and return to work or daily activities and may result in increased use and cost of rehabilitation services. The purpose of this study is to determine if following a RC repair, patients can safely stop wearing their sling and begin active ROM for activities of daily living as early as pain and comfort allow. A total of 190 patients have been recruited to this study (95/group) were randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as needed) will be allowed to remove their sling as early as pain and comfort allow. Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily living. Patients who agree to participate will be seen by their surgeon and the research coordinator for a baseline assessment before surgery and again at 2 & 6 weeks, 3, 6, 12 and 24 months after surgery. Each visit will include a ROM assessment and disease specific quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of 2 years after surgery to verify the integrity of their RC repair. Differences in ROM, questionnaire scores, RC integrity and adverse events will be examined between the two groups.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Shoulder & Upper Extremity Research Group of Edmonton.