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

• ClinicalTrials.gov Identifier: NCT00290888
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Results First Posted: May 9, 2014
• Last Update Posted: March 27, 2015
• Sponsor: Panam Clinic
• Information provided by (Responsible Party): Peter MacDonald, Panam Clinic

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Rotator Cuff Tear; Shoulder Impingement Syndrome	Procedure: Acromioplasty	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
• Study Start Date: April 2004
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ACR; Arthroscopic rotator cuff repair without acromioplasty	Procedure: Acromioplasty
Experimental: ACR-A; Arthorscopic rotator cuff repair with acromioplasty	Procedure: Acromioplasty

Outcome Measures

Primary Outcome Measures :

1. Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 24 months ]
   Calculated as percentage with an increase in score indicating an improvement in outcome.
2. American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) [ Time Frame: 24 months ]
   Calculated as a percentage with an increase in score reflecting an improvement in outcome.

Secondary Outcome Measures :

1. Shoulder Range of Motion [ Time Frame: 24 months ]
2. Upper Extremity Strength Grading [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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. Débridement 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.

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.

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.

• Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic
• ClinicalTrials.gov Identifier: NCT00290888
• Other Study ID Numbers: B2004:045
• First Posted: February 13, 2006
• Results First Posted: May 9, 2014
• Last Update Posted: March 27, 2015
• Last Verified: March 2015

Keywords provided by Peter MacDonald, Panam Clinic:

Rotator Cuff Tear; Tendon Repair; Acromioplasty; Arthroscopy; Orthopedic Surgery

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases