Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis

April 24, 2014 updated by: Dianne Bryant, University of Western Ontario, Canada

A Randomized Clinical Trial Comparing the Effectiveness of Subacromial Decompression (Acromioplasty) Versus Subacromial Bursectomy (no Acromioplasty) in the Arthroscopic Treatment of Patients With Rotator Cuff Tendinosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The most commonly performed surgical procedure to treat rotator cuff tendinosis, when no full-thickness tear exists, is subacromial decompression (acromioplasty). This procedure is based on the theory that primary acromial morphology, (an extrinsic cause), is the initiating factor leading to the dysfunction and eventual tearing of the rotator cuff.

Subacromial decompression involves surgical excision of the subacromial bursa, resection of the coracoacromial ligament, resection of the anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement.

Several studies have indicated that the vast majority of partial-thickness tears are found on the articular surface of the rotator cuff which is not in keeping with the theory that rotator cuff impingement is primarily a result of acromion morphology.

Burkhart proposed that pathologic changes in the supraspinatus tendon occur primarily as a result of overuse and tension overload (an intrinsic factor), resulting in superior migration of the humeral head during active elevation.

Budoff et al., suggest that since the coracoacromial ligament stabilizes the rotator cuff to prevent uncontrolled superior migration of the humeral head, resection of the coracoacromial ligament during arthroscopic subacromial decompression may cause, in the long-term, additional proximal migration of the humeral head.

Arthroscopic bursectomy with debridement of rotator cuff tears alone, without acromioplasty, addresses the primary anatomical pathology and may offer similar success rates to subacromial decompression, without the risk of future instability caused by resection of the acromion and coracoacromial ligament.

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Sport Medicine Centre
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 5P5
        • Royal Columbian Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Pan Am Medical and Surgical Centre
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic
      • London, Ontario, Canada, N6A 4L6
        • Hand and Upper Limb Clinic
      • Toronto, Ontario, Canada, M4Y 1H1
        • Orthopaedic and Arthritic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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

  2. 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.
  3. Patients willing to be followed on a regular basis
  4. Patients 18 years of age and older

Exclusion Criteria:

  1. Clinical evidence or history of major joint trauma, infection, surgery, glenohumeral arthritis, or instability.
  2. Clinical evidence of internal impingement.
  3. Patients with full-thickness rotator cuff tear as documented on advanced imaging or during surgery.
  4. Patients with bursal surface tears as documented on advanced imaging or during surgery.
  5. Patients who are found during surgery to have a partial-thickness tear greater than 50% of tendon thickness.
  6. Patients with evidence of a lateral down sloping acromion.
  7. Patients unfit for surgery
  8. Patients unable to provide informed consent or adequately participate in this study due to a language barrier or psychiatric illness.
  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shoulder bursectomy and acromioplasty
Procedure: Shoulder bursectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario Rotator Cuff (WORC) index
Time Frame: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Collaborators

Fowler Kennedy Sport Medicine Clinic

Investigators

  • Principal Investigator: Kevin Willits, MD, FRCS(C), Fowler Kennedy Sport Medicine Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC-AOSSM-1
  • WillitsYIG1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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