Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fowler Kennedy Sport Medicine Clinic
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00196573
First received: September 12, 2005
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Tendinosis
Shoulder Impingement Syndrome
Procedure: Shoulder bursectomy alone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • The Western Ontario Rotator Cuff (WORC) index [ Time Frame: Baseline, 2 & 6 weeks, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    a disease specific quality of life measure for rotator cuff disease evaluated pre-operatively and at all post-operative visits


Estimated Enrollment: 114
Study Start Date: November 2003
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Shoulder bursectomy and acromioplasty Procedure: Shoulder bursectomy alone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196573

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 5P5
Canada, Manitoba
Pan Am Medical and Surgical Centre
Winnipeg, Manitoba, Canada, R3M 3E4
Canada, Ontario
Hand and Upper Limb Clinic
London, Ontario, Canada, N6A 4L6
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Orthopaedic and Arthritic Hospital
Toronto, Ontario, Canada, M4Y 1H1
Sponsors and Collaborators
University of Western Ontario, Canada
Fowler Kennedy Sport Medicine Clinic
Investigators
Principal Investigator: Kevin Willits, MD, FRCS(C) Fowler Kennedy Sport Medicine Clinic
  More Information

Publications:
Alvarez C, Kirkley A. The development of a disease specific quality of life measurement tool for rotator cuff disease. Presented at 23rd Clinical Seminar in Orthopaedic Surgery, London, Canada. May, 1995.
Brown JT. Early assessment of supraspinatus tears: Procaine infiltration as a guide to treatment. Journal of Bone and Joint Surgery (British) 31: 423-425, 1949.
Burkhead WZ. Symposium: the rotator Cuff: debridement versus repair - part I. Contemporary Orthopedics 31:262-271, 1995.
Burkhead WZ. Symposium: the rotator Cuff: debridement versus repair - part II. Contemporary Orthopedics 31:313-326, 1995.
Coomes EN, Darling LG. Effects of local steroid injection for supraspinatus tears - Controlled Study. Annals of the rheumatic diseases 35: 943, 1976.
Ellman H. Arthroscopic subacromial decompression: A preliminary report. Ortop Trans 19:43, 1985.
Ellman H, Kay SP. Arthroscopic subacromial decompression 2-5 year results. Orthop Trans 13:239, 1989
Iannotti JP (Ed). Rotator Cuff Disorders. American Academy of Orthopaedic Surgeons Monograph Series. Park Ridge, Illinois, 1991.
Kibler WB, Chandler TJ. Functional scapular instability in throwing athletes. American Orthopaedic Society for Sports Medicine 15th Annual Meeting. Traverse City, Michigan, June 19-22, 1989.
Mack LA, Matson FA, Kilcoyne JF, et al. UD evaluation of the rotator cuff. Radiology 57:205-209, 1985.
Matsen FA III, Arntz CT. Subacromial Impingement, in Rockwood CA Jr, Matsen FA II (eds): The Shoulder. Philadelphia, WB Saunders, 1990, pg 623-648.
Montgomery TJ, Yerger B, Savoie FH. Management of full thickness tears of the rotator cuff: a comparison of arthroscopic debridement with open repair. Presented at the 8th annual Open Meeting of American Shoulder and Elbow Surgeons, Washington, DC, 1992.
Rockwood CA, Burkhead WZ. Management of patients with massive rotator cuff defects by acromioplasty and rotator cuff debridement. Orthop Trans 12:190-191, 1988.
Steel RGD, Torrie JH. Principles of procedures of statistics. A biometric approach (2nd ed). McGraw-Hill Book Co. New York, NY, 1980.
Watson MS. Classification of the painful arc syndromes. Bayley JI, Kessel L (eds). Shoulder Surgery. New York, NY, Springer-Verlag New York INC, 1982.
Wickiewicz, TL. Glenohumeral kinematics in a muscle fatigue model: a radiographic study. Orthop Trans 18:178-179, 1994.

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00196573     History of Changes
Other Study ID Numbers: FKSMC-AOSSM-1, WillitsYIG1
Study First Received: September 12, 2005
Last Updated: April 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Western Ontario, Canada:
Rotator Cuff
Tendinosis
Impingement Syndrome
Partial Thickness Tears
Rotator Cuff Tendinosis
Partial Thickness Rotator Cuff Tears

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Tendinopathy
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014