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

November 7, 2005
January 14, 2008
March 1999
October 2005   (final data collection date for primary outcome measure)
Rotator Cuff Quality of Life Questionnaire (RC-QOL) [ Time Frame: Baseline, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
Rotator Cuff Quality of Life Questionnaire (RC-QOL)
Complete list of historical versions of study NCT00251147 on ClinicalTrials.gov Archive Site
  • 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 ]
  • American Shoulder and Elbow Surgeons Score
  • Shoulder Rating Questionnaire
  • Functional Shoulder Elevation Test
  • Range of motion
  • Strength
Not Provided
Not Provided
 
A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.
Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rotator Cuff Tear
  • 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
  • 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
  • Active Comparator: Open Repair
    Intervention: Procedure: Open acromioplasty with rotator cuff repair
  • Active Comparator: Mini-open Repair
    Intervention: Procedure: Arthroscopic acromioplasty with mini-open repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00251147
10368
No
Denise Chan, Orthopaedic Research Coordinator, University of Calgary
University of Calgary
  • Workers' Compensation Board - Alberta
  • Canadian Orthopaedic Foundation
Principal Investigator: Robert Hollinshead, MD, FRCSC University of Calgary Sport Medicine Centre
Principal Investigator: Nicholas Mohtadi, MD, FRCSC University of Calgary Sport Medicine Centre
University of Calgary
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP