Early Mobilization Following Mini-Open Rotator Cuff Repair

NCT01741272 | Completed Phase 4 Results

• 1 other identifier: Pro00001096
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Full Thickness Rotator Cuff Tears

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Range of Motion (ROM)From Baseline to 24 Months

  Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level). Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.

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

Secondary Outcomes (4)

• Pain Questionnaire

  Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months

• WORC Questionnaire

  Baseline, 6, 12, 24 months

• Abduction Strength Using the Power Component of the Constant Score

  Baseline, 24 months

• Complications

  2 & 6 weeks, 3, 6, 12, 24 months

Study Arms (2)

Group A (Usual Care)

ACTIVE COMPARATOR

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

Procedure: Sling

Group B (Early ROM)

EXPERIMENTAL

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

Procedure: No sling

Interventions

Sling PROCEDURE

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

Group A (Usual Care)

No sling 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.

Group B (Early ROM)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, 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: Dr. Robert Balyk
• Organization: Alberta Health Services

rbalyk6@aol.com

7804395858

Study Officials

• Robert Balyk, MD, FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2003
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 28, 2021
• Results First Posted: March 17, 2015

Record last verified: 2021-10

Locations

CA (1)