Early Mobilization Following Mini-Open Rotator Cuff Repair

NCT ID: NCT01741272

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Full Thickness Rotator Cuff Tears

Keywords

rotator cuff tear; arthroscopically assisted; health related quality of life(HRQL); functional outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (Usual Care)

Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling

Group Type: ACTIVE_COMPARATOR

Sling

Intervention Type: PROCEDURE

Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.

Group B (Early ROM)

Will use the sling for comfort only. Intervention: Procedure: No sling

Group Type: EXPERIMENTAL

No sling

Intervention Type: PROCEDURE

Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.

Interventions

Sling

Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Balyk, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00001096

Identifier Type: -

Identifier Source: org_study_id