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

Overview

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.

Full Title of Study: “Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

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.

Interventions

  • Procedure: Acromioplasty

Arms, Groups and Cohorts

  • Active Comparator: ACR
    • Arthroscopic rotator cuff repair without acromioplasty
  • Experimental: ACR-A
    • Arthorscopic rotator cuff repair with acromioplasty

Clinical Trial Outcome Measures

Primary Measures

  • Western Ontario Rotator Cuff Index (WORC)
    • Time Frame: 24 months
    • Calculated as percentage with an increase in score indicating an improvement in outcome.
  • 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 Measures

  • Shoulder Range of Motion
    • Time Frame: 24 months
  • Upper Extremity Strength Grading
    • Time Frame: 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Panam Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter MacDonald, Department Head, Orthopaedics – Panam Clinic
  • Overall Official(s)
    • Peter MacDonald, MD, FRCS(C), Principal Investigator, Panam Clinic Orthopedics and Sports Medicine/University of Manitoba

References

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. doi: 10.1177/03635465980260060501.

Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104. doi: 10.1177/036354659502300117.

Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9. doi: 10.1016/s0749-8063(96)90192-9.

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. doi: 10.2106/00004623-199805000-00016. 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. doi: 10.1016/s0749-8063(97)90123-7.

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

Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13. doi: 10.1016/0749-8063(91)90071-5.

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. doi: 10.1016/s0749-8063(05)80374-3.

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.

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