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A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.

This study has been completed.
Sponsor:
Collaborators:
Workers' Compensation Board - Alberta
Canadian Orthopaedic Foundation
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00251147
First received: November 7, 2005
Last updated: January 14, 2008
Last verified: January 2008
  Purpose

This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rotator cuff tears.

Hypothesis: There is no difference in disease-specific quality of life outcome at two years between open versus arthroscopic mini-open repair for patients with full-thickness rotator cuff tears.


Condition Intervention
Rotator Cuff Tear
Procedure: Open acromioplasty with rotator cuff repair
Procedure: Arthroscopic acromioplasty with mini-open repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Rotator Cuff Quality of Life Questionnaire (RC-QOL) [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Shoulder and Elbow Surgeons Score [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Shoulder Rating Questionnaire [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Functional Shoulder Elevation Test [ Time Frame: Baseline, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Strength [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: March 1999
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open Repair Procedure: Open acromioplasty with rotator cuff repair
A standard vertical incision was made over the anterolateral aspect of the acromion. The deltoid muscle was split and stripped off the anterior aspect of the acromion. The anterior and inferior aspect of the acromion was removed. The coracoacromial ligament was excised. Repair of the tear in the cuff tendon(s) was accomplished by suturing leading edge of the tear into the greater tuberosity of the humerus at or near the original site of insertion of the cuff to bone. Trans-osseous sutures, suture anchors and tendon to tendon suture repair techniques were employed for a secure repair with the arm at the side. The surgeon was allowed to use whatever method(s) to create a secure repair. The deltoid was securely reattached to the acromion with the deltoid fascia repaired down the split.
Other Name: Open repair
Active Comparator: Mini-open Repair Procedure: Arthroscopic acromioplasty with mini-open repair
A standard arthroscopic gleno-humeral arthroscopy was performed followed by an arthroscopic acromioplasty. Three standard arthroscopic portals were used. The lateral portal was centered in line with the cuff tear, and incorporated into the mini-open incision. Initially, a partial bursectomy was performed to improve visualization. The inferior surface of the anterior acromion and the coracoacromial ligament were removed. Following the arthroscopic acromioplasty, a 3-4cm lateral incision was performed in the area of the lateral portal. The deltoid muscle was split longitudinally to expose the tear in the rotator cuff. The tear was repaired in a similar manner to the open repair with tendon to tendon sutures, trans-osseous sutures and with suture anchors.
Other Names:
  • Mini-open repair
  • Scope mini-open

Detailed Description:

Rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's quality of life.

The standard treatment for full-thickness rotator cuff repair is with an open acromioplasty procedure. An alternative procedure for a full-thickness rotator cuff tear is with a combined procedure of arthroscopic acromioplasty and mini-open repair, which has the potential advantages of a preserved deltoid origin, lower perioperative morbidity, shorter hospital stays and less soft tissue dissection. The progression towards arthroscopic repair requires a comparison to the standard, open procedure for full-thickness rotator cuff tears, using validated outcomes in a randomized fashion.

This study is designed as a multi-centre randomized controlled trial with a priori sample size calculation of 28 patients per group. Patients presenting with unremitting pain, failed conservative treatment of at least 3 months, weakness of the rotator cuff and positive imaging indicating a full-thickness rotator cuff tear are eligible for the study. Previous surgery on the affected shoulder and massive rotator cuff tears are excluded. Patients are randomized using computer-generated block randomization, stratified by surgeon, to either open or mini-open rotator cuff repair.

Disease-specific quality of life is assessed using the validated Rotator Cuff Quality of Life Questionnaire, a self-administered, 34-item questionnaire designed specifically to assess patients before and after surgery. It utilizes a visual analog scale scored out of 100, with a higher score reflecting a better quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unremitting pain in the affected shoulder who have failed conservative treatment for at least 3 months
  • Weakness of rotator cuff (MRC grades 4-, 4 or 4+)
  • Positive diagnostic imaging on the affected shoulder indicating a full-thickness rotator cuff tear which may include arthrogram, ultrasound or MRI
  • Age > 18 years
  • English speaking

Exclusion Criteria:

  • A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
  • Previous surgery to the affected shoulder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251147

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Canada, Ontario
Fowler Kennedy Sport Medicine Centre
London, Ontario, Canada, N6A 3K7
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4Y 1H1
Sponsors and Collaborators
University of Calgary
Workers' Compensation Board - Alberta
Canadian Orthopaedic Foundation
Investigators
Principal Investigator: Robert Hollinshead, MD, FRCSC University of Calgary Sport Medicine Centre
Principal Investigator: Nicholas Mohtadi, MD, FRCSC University of Calgary Sport Medicine Centre
  More Information

No publications provided

Responsible Party: Denise Chan, Orthopaedic Research Coordinator, University of Calgary
ClinicalTrials.gov Identifier: NCT00251147     History of Changes
Other Study ID Numbers: 10368
Study First Received: November 7, 2005
Last Updated: January 14, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
rotator cuff
open
arthroscopic
mini-open
acromioplasty
quality of life
shoulder

ClinicalTrials.gov processed this record on November 25, 2014