Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis

NCT00196573 | Unknown Phase 3

• 2 other identifiers: FKSMC-AOSSM-1WillitsYIG1
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to compare the effectiveness of arthroscopic subacromial decompression (acromioplasty) to arthroscopic subacromial bursectomy (no acromioplasty) in rotator cuff impingement syndrome. The investigators' hypothesis is that arthroscopic subacromial decompression provides no additional benefit, as evaluated with disease specific quality of life measures, compared to arthroscopic bursectomy.

Conditions

Tendinosis; Shoulder Impingement Syndrome

Keywords

Rotator Cuff; Tendinosis; Impingement Syndrome; Partial Thickness Tears; Rotator Cuff Tendinosis; Partial Thickness Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• The Western Ontario Rotator Cuff (WORC) index

  a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits

  Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months

Study Arms (1)

Shoulder bursectomy and acromioplasty

ACTIVE COMPARATOR

Procedure: Shoulder bursectomy alone

Interventions

Shoulder bursectomy alone PROCEDURE

Shoulder bursectomy and acromioplasty

Eligibility Criteria

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

You may qualify if:

• Diagnosis of stage II rotator cuff impingement syndrome defined as:
• Pain referred to the anterior, lateral, or superior shoulder
• Pain exacerbated by overhead and reaching activities
• Positive Neer and/or Hawkins impingement signs
• Failure of 6 months of conservative treatment. Failed conservative treatment will be defined as persistent pain and disability despite adequate non-operative management for 6 months. Non-operative management will be defined as:
• Modification of activities
• The use of analgesic and/or anti-inflammatory medication
• Physiotherapy: Physiotherapy must have included the goal of regaining full range of motion, working towards normal kinematics through increased strength of the rotator cuff muscles. Patients should have obtained range of motion to 80% of the opposite shoulder (assuming this is normal) for each of: internal rotation, external rotation, and forward elevation. A physiotherapy program that involved massage, ultrasound, and/or heat only would not be considered adequate treatment for this study.
• Patients willing to be followed on a regular basis
• Patients 18 years of age and older

You may not qualify if:

• Clinical evidence or history of major joint trauma, infection, surgery, glenohumeral arthritis, or instability.
• Clinical evidence of internal impingement.
• Patients with full-thickness rotator cuff tear as documented on advanced imaging or during surgery.
• Patients with bursal surface tears as documented on advanced imaging or during surgery.
• Patients who are found during surgery to have a partial-thickness tear greater than 50% of tendon thickness.
• Patients with evidence of a lateral down sloping acromion.
• Patients unfit for surgery
• Patients unable to provide informed consent or adequately participate in this study due to a language barrier or psychiatric illness.
• Patients with a major medical illness whose condition or treatment would affect their quality of life and, as such, affect the results of this study.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Fowler Kennedy Sport Medicine Clinic: collaborator

Study Sites (6)

University of Calgary Sport Medicine Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 5P5, Canada

Location

Pan Am Medical and Surgical Centre

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Hand and Upper Limb Clinic

London, Ontario, N6A 4L6, Canada

Location

Orthopaedic and Arthritic Hospital

Toronto, Ontario, M4Y 1H1, Canada

Location

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MeSH Terms

Conditions

Tendinopathy; Shoulder Impingement Syndrome; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Joint Diseases; Shoulder Injuries; Rupture

Study Officials

• Kevin Willits, MD, FRCS(C)

  Fowler Kennedy Sport Medicine Clinic

  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: Associate Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2003
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

CA (6)