Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty - Full Text View

Sponsored by:	Panam Clinic
Information provided by:	Panam Clinic
ClinicalTrials.gov Identifier:	NCT00290888

Purpose

Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.

Condition	Intervention
Rotator Cuff Tear Shoulder Impingement Syndrome	Procedure: Acromioplasty

MedlinePlus related topics: Shoulder Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff

Further study details as provided by Panam Clinic:

Primary Outcome Measures:

Western Ontario Rotator Cuff Index (WORC)
American Shoulder and Elbow Surgeons standardized form for the assessment of the shoulder (ASES)
Time of both measures: pre-op (1 month); post-op at 6 weeks, 3, 6, 12, 18, and 24 months

Secondary Outcome Measures:

Shoulder range of motion
Upper extremity strength grading
Time of measures: pre-op (1 month); post-op at 6 weeks, 3, 6, 12, 18, and 24 months

Estimated Enrollment:	86
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone.

The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff.

We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.

Eligibility

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

Criteria

Inclusion Criteria:

Ages 18 or older
Complete rotator cuff tear up to 4 cm in size
Persistent pain and functional disability for at least 6 months
Failure of conservative treatment
Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability

Exclusion Criteria:

Evidence of significant osteoarthritis or cartilage damage in the shoulder
Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
Previous surgeries of the shoulder
Evidence of major joint trauma, infection, or necrosis in the shoulder
Patients with partial thickness tears of the rotator cuff
Patients unable to provide informed consent due to language barrier or mental status
Patients with a major medical condition that would affect quality of life and influence the results of the study
Patients with worker compensation claims
Patients unwilling to be followed for the duration of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290888

Locations

Canada, Manitoba
Panam Clinic
Winnipeg, Manitoba, Canada, R3M 3E4

Sponsors and Collaborators

Panam Clinic

Investigators

Principal Investigator:

Peter MacDonald, MD, FRCS(C)

Panam Clinic Orthopedics and Sports Medicine/University of Manitoba

More Information

Publications:

Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72.

Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104.

Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9.

Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.

Budoff JE, Nirschl RP, Guidi EJ. Debridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. Review. No abstract available.

Gartsman GM, Taverna E. The incidence of glenohumeral joint abnormalities associated with full-thickness, reparable rotator cuff tears. Arthroscopy. 1997 Aug;13(4):450-5.

Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71. Review.

Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13.

Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.

Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.

Ellman H, Kay SP, Wirth M. Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy. 1993;9(2):195-200.

Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.

Study ID Numbers:	B2004:045
Study First Received:	February 10, 2006
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00290888
Health Authority:	Canada: Health Canada

Keywords provided by Panam Clinic:

Rotator Cuff Tear
Tendon Repair
Acromioplasty
Arthroscopy
Orthopedic Surgery

Study placed in the following topic categories:

Lacerations
Musculoskeletal Diseases
Joint Diseases
Shoulder Impingement Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009