All-Arthroscopic Versus Mini-Open Repair of Small or Moderate Rotator Cuff Tears

NCT00128076 | Completed Phase 3 DMC

• 1 other identifier: MCT-82335
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 9

Brief Summary

This study will compare two different surgical techniques for repairing a tear in the muscles of the shoulder (rotator cuff). The investigators will determine whether an arthroscopic or mini-open technique provides better quality of life and repair integrity.

Conditions

Shoulder Pain; Rotator Cuff Tear

Keywords

shoulder surgery; rotator cuff; arthroscopic repair; mini-open repair

Outcome Measures

Primary Outcomes (1)

• Quality of life measure specific to rotator cuff disease (Western Ontario Rotator Cuff Questionnaire (WORC)

  within 2 years

Secondary Outcomes (7)

• SF-12

  within 2 years

• Work Limitations Scale

  within 2 years

• Cuff integrity on imaging

  within 1 year post-operative

• Strength

  within 2 years

• Range of Motion

  within 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

All-arthroscopic repair

Procedure: All-Arthroscopic repair

2

ACTIVE COMPARATOR

Mini-open repair

Procedure: Mini-open repair

Interventions

All-Arthroscopic repair PROCEDURE

joint techniques and repair are both performed entirely through the arthroscope

1

Mini-open repair PROCEDURE

repair is performed though a small incision and the arthroscope can be used to address problems within the joint (as per traditional diagnostic procedures)

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will recruit patients with small or medium rotator cuff tears as determined by clinical examination and diagnostic imaging (magnetic resonance imaging \[MRI\]) prior to surgery.
• The full-thickness rotator cuff tears of supraspinatus and infraspinatus will be classified into 2 categories based on area of longest dimension.
• SMALL= 0-1 cm;
• MODERATE =1-3 cm.
• Definitive measurement of tear size will be made in surgery and used as a covariate in analysis. (JOINTS measurement protocol will be used)

You may not qualify if:

• Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder or previous surgery of the affected shoulder,
• Evidence of significant cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations,
• Major medical illness (life expectancy less then 2 years or unacceptably high operative risk),
• Unable to speak or read English,
• Psychiatric illness that precludes informed consent,
• Unwilling to be followed for 2 years.
• Large, massive or irreparable cuff tears, extending into the subscapularis or teres minor, which cannot be mobilized to the articular margin or repaired using one or both of the techniques (all arthroscopic or mini-open),
• Teres minor or subscapularis tears,
• Inelastic and immobile tendon, which cannot be advanced to articular margin,
• Co-existing labral pathologies requiring repair with sutures (superior labral anterior posterior \[SLAP\] II-IV), Bankart lesions requiring repair, partial tears of biceps (more than 60% of thickness) requiring tenodesis or release.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (9)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Walter Mackenzie Centre

Edmonton, Alberta, T6B 2G7, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3S 3W7, Canada

Location

PanAm Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Orthopaedic and Arthritic Hospital

Toronto, Ontario, Canada

Location

Related Publications (2)

• MacDermid JC, Holtby R, Razmjou H, Bryant D; JOINTS Canada. All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: a protocol for a randomized trial [NCT00128076]. BMC Musculoskelet Disord. 2006 Mar 10;7:25. doi: 10.1186/1471-2474-7-25.

  PMID: 16529658 BACKGROUND

• MacDermid JC, Bryant D, Holtby R, Razmjou H, Faber K; JOINTS Canada; Balyk R, Boorman R, Sheps D, McCormack R, Athwal G, Hollinshead R, Lo I, Bicknell R, Mohtadi N, Bouliane M, Glasgow D, Lebel ME, Lalani A, Moola FO, Litchfield R, Moro J, MacDonald P, Bergman JW, Bury J, Drosdowech D. Arthroscopic Versus Mini-open Rotator Cuff Repair: A Randomized Trial and Meta-analysis. Am J Sports Med. 2021 Oct;49(12):3184-3195. doi: 10.1177/03635465211038233. Epub 2021 Sep 15.

  PMID: 34524031 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Joy C MacDermid, PhD

  McMaster University, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2005
• First Posted: August 9, 2005
• Study Start: August 1, 2006
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

CA (9)