Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis

Last updated: April 24, 2014
Sponsor: University of Western Ontario, Canada
Overall Status: Trial Status Unknown

Phase

3

Condition

Tendon Injuries

Sprains

Treatment

N/A

Clinical Study ID

NCT00196573
FKSMC-AOSSM-1
WillitsYIG1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

  1. Failure of 6 months of conservative treatment. Failed conservative treatment will bedefined as persistent pain and disability despite adequate non-operative managementfor 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 rangeof motion, working towards normal kinematics through increased strength of therotator cuff muscles. Patients should have obtained range of motion to 80% of theopposite shoulder (assuming this is normal) for each of: internal rotation,external rotation, and forward elevation. A physiotherapy program that involvedmassage, ultrasound, and/or heat only would not be considered adequate treatmentfor this study.

  1. Patients willing to be followed on a regular basis

  2. Patients 18 years of age and older

Exclusion

Exclusion Criteria:

  1. Clinical evidence or history of major joint trauma, infection, surgery, glenohumeralarthritis, or instability.

  2. Clinical evidence of internal impingement.

  3. Patients with full-thickness rotator cuff tear as documented on advanced imaging orduring surgery.

  4. Patients with bursal surface tears as documented on advanced imaging or duringsurgery.

  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 studydue to a language barrier or psychiatric illness.

  9. Patients with a major medical illness whose condition or treatment would affect theirquality of life and, as such, affect the results of this study.

Study Design

Total Participants: 114
Study Start date:
November 01, 2003
Estimated Completion Date:
December 31, 2014

Study 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.

Connect with a study center

  • University of Calgary Sport Medicine Centre

    Calgary, Alberta T2N 1N4
    Canada

    Site Not Available

  • Royal Columbian Hospital

    New Westminster, British Columbia V3L 5P5
    Canada

    Site Not Available

  • Pan Am Medical and Surgical Centre

    Winnipeg, Manitoba R3M 3E4
    Canada

    Site Not Available

  • Fowler Kennedy Sport Medicine Clinic

    London, Ontario N6A 3K7
    Canada

    Site Not Available

  • Hand and Upper Limb Clinic

    London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Orthopaedic and Arthritic Hospital

    Toronto, Ontario M4Y 1H1
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.