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

Rotator Cuff Tear Clinical Trial

Official title:

Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290888
• Other study ID #: B2004:045
• Status: Completed
• Phase: N/A
• First received: February 10, 2006
• Last updated: March 9, 2015
• Start date: April 2004
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: Panam Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear
• Shoulder Impingement Syndrome

Intervention

Procedure:
• Acromioplasty

Locations

Country	Name	City	State
Canada	Panam Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Panam Clinic

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff Index (WORC)	Calculated as percentage with an increase in score indicating an improvement in outcome.	24 months	No
Primary	American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)	Calculated as a percentage with an increase in score reflecting an improvement in outcome.	24 months	No
Secondary	Shoulder Range of Motion		24 months	No
Secondary	Upper Extremity Strength Grading		24 months	No