Clinical trial NCT01741272: Early Mobilization Following Mini-Open Rotator Cuff Repair
Official title: Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Full Thickness Rotator Cuff Tears
Keywords: rotator cuff tear
arthroscopically assisted
health related quality of life(HRQL)
functional outcome
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Range of Motion (ROM)From Baseline to 24 Months
timeFrame: Baseline, 6 weeks, 3, 6, 12, 24 months
Secondary outcomes:
measure: Pain Questionnaire
timeFrame: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months
measure: WORC Questionnaire
timeFrame: Baseline, 6, 12, 24 months
measure: Abduction Strength Using the Power Component of the Constant Score
timeFrame: Baseline, 24 months
measure: Complications
timeFrame: 2 & 6 weeks, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Robert Balyk, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: