Early Mobilization Following Arthroscopic Rotator Cuff Repair

NCT01333527 | Completed Results

• 1 other identifier: RES0005824
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• Western Ontario Rotator Cuff Index (WORC)

  a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best

  Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

• Range of Motion (ROM)

  Measured flexion, abduction, external rotation in 90 degrees abduction \[ER(90)\], internal rotation in 90 degrees abduction \[IR(90)\], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout

  baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Secondary Outcomes (4)

• Strength

  Baseline, 6 months, 12 months, 24 months

• The Short Form (36) Health Survey

  baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

• Adverse Events

  2 weeks, 6 weeks, 3 months, 6months

• Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months

  baseline, 6 weeks, 3, 6, 12, 24 months

Study Arms (2)

Group A (early ROM)

EXPERIMENTAL

Group A (early ROM) will use the sling for comfort only

Procedure: No Sling

Group B (usual care)

ACTIVE COMPARATOR

Group B (usual care) will be immobilized in a sling for 6 weeks.

Procedure: Sling

Interventions

No Sling PROCEDURE

Early range of motion

Group A (early ROM)

Sling PROCEDURE

Patients will use the sling for 6 weeks, as per usual care

Group B (usual care)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is over 18 years of age
• Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
• Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

You may not qualify if:

• Patient has a full-thickness tear of the subscapularis and/or teres minor
• Patient has undergone previous RC surgery to the affected shoulder
• Patient has major joint trauma, infection, or avascular necrosis
• Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
• Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
• 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
• Patient has a major medical illness where life expectancy is less than 2 years
• Patient does not speak/read/understand English
• Patient has no fixed address or means of contact
• Surgeon or patient has decided to cancel surgery
• Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
• Patient unwilling to complete necessary follow-ups

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Glen Sather Sports Medicine clinic

Edmonton, Alberta, T6G 2H9, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Anelise Silveira
• Organization: Research Associate

anelise.silveira@ahs.ca

780-492-2398

Study Officials

• David Sheps, MD,MSc,FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: May 2, 2018
• Last Updated: October 15, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-10

Locations

CA (1)