Brief Summary

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Official Title: "Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial"

Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.

This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:

Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.

Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.

Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: December 2015

Interventions Used in this Clinical Trial

• Procedure: No Sling
  • Early range of motion
• Procedure: Sling
  • Patients will use the sling for 6 weeks, as per usual care

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A (early ROM)
  • Group A (early ROM) will use the sling for comfort only
• Active Comparator: Group B (usual care)
  • Group B (usual care) will be immobilized in a sling for 6 weeks.

Outcome Measures for this Clinical Trial

Primary Measures

• WORC Questionnaire
  • Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
    Safety Issue?: No

Secondary Measures

• Strength
  • Time Frame: Baseline, 6 months, 12 months, 24 months
    Safety Issue?: No
• ASES
  • Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
    Safety Issue?: No
• Adverse Events
  • Time Frame: 2 weeks, 6 weeks, 3 months, 6months
    Safety Issue?: No
• SF-36
  • Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
    Safety Issue?: No
• Range of Motion (ROM)
  • Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. Patient is over 18 years of age

2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)

3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria

1. Patient has a full-thickness tear of the subscapularis and/or teres minor

2. Patient has undergone previous RC surgery to the affected shoulder

3. Patient has major joint trauma, infection, or avascular necrosis

4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy

5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)

6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires

7. Patient has a major medical illness where life expectancy is less than 2 years

8. Patient does not speak/read/understand English

9. Patient has no fixed address or means of contact

10. Surgeon or patient has decided to cancel surgery

11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)

12. Patient unwilling to complete necessary follow-ups

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Shoulder & Upper Extremity Research Group of Edmonton
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • David Sheps, MD,MSc,FRCSC, Principal Investigator, University of Alberta
• Overall Contact(s)
  • Anelise Silveira, 780-407-6992, anelise.silveira@albertahealthservices.ca