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

NCT00251147 | Completed

• 1 other identifier: 10368
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff; open; arthroscopic; mini-open; acromioplasty; quality of life; shoulder

Outcome Measures

Primary Outcomes (1)

• Rotator Cuff Quality of Life Questionnaire (RC-QOL)

  Baseline, 3, 6, 12, 24 months

Secondary Outcomes (5)

• American Shoulder and Elbow Surgeons Score

  Baseline, 3, 6, 12, 24 months

• Shoulder Rating Questionnaire

  Baseline, 3, 6, 12, 24 months

• Functional Shoulder Elevation Test

  Baseline, 6, 12, 24 months

• Range of motion

  Baseline, 3, 6, 12, 24 months

• Strength

  Baseline, 3, 6, 12, 24 months

Study Arms (2)

Open Repair

ACTIVE COMPARATOR

Procedure: Open acromioplasty with rotator cuff repair

Mini-open Repair

ACTIVE COMPARATOR

Procedure: Arthroscopic acromioplasty with mini-open repair

Interventions

Open acromioplasty with rotator cuff repair PROCEDURE

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.

Also known as: Open repair

Open Repair

Arthroscopic acromioplasty with mini-open repair PROCEDURE

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.

Also known as: Mini-open repair, Scope mini-open

Mini-open Repair

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Workers' Compensation Board, Alberta: collaborator
• Canadian Orthopaedic Foundation: collaborator

Study Sites (4)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Fowler Kennedy Sport Medicine Centre

London, Ontario, N6A 3K7, Canada

Location

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Robert Hollinshead, MD, FRCSC

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

• Nicholas Mohtadi, MD, FRCSC

  University of Calgary Sport Medicine Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: March 1, 1999
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: January 17, 2008

Record last verified: 2008-01

Locations

CA (4)