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

NCT00290888 | Completed Results

• 1 other identifier: B2004:045
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear; Shoulder Impingement Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Western Ontario Rotator Cuff Index (WORC)

  Calculated as percentage with an increase in score indicating an improvement in outcome.

  24 months

• 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

Secondary Outcomes (2)

• Shoulder Range of Motion

  24 months

• Upper Extremity Strength Grading

  24 months

Study Arms (2)

ACR

ACTIVE COMPARATOR

Arthroscopic rotator cuff repair without acromioplasty

Procedure: Acromioplasty

ACR-A

EXPERIMENTAL

Arthorscopic rotator cuff repair with acromioplasty

Procedure: Acromioplasty

Interventions

Acromioplasty PROCEDURE

ACR; ACR-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Panam Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (12)

• 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.

  PMID: 9850776 BACKGROUND

• 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.

  PMID: 7726359 BACKGROUND

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

  PMID: 8902127 BACKGROUND

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

  PMID: 8196974 BACKGROUND

• 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.

  PMID: 9611036 BACKGROUND

• 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.

  PMID: 9276051 BACKGROUND

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

  PMID: 8421609 BACKGROUND

• 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.

  PMID: 2009126 BACKGROUND

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

  PMID: 4019548 BACKGROUND

• 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.

  PMID: 8358901 BACKGROUND

• 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.

  PMID: 8461081 BACKGROUND

• 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.

  PMID: 5054450 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

Variation in surgical technique and post-op rehabilitation. We do not have confirmation of cuff healing status as no imaging was carried out post-operatively. Assessment of AC morphology is subjective \& based solely on pre-operative radiographs.

Results Point of Contact

• Title: Dr. Peter MacDonald
• Organization: Pan Am Clinic

pmacdonald@panamclinic.com

204-925-7480

Study Officials

• Peter MacDonald, MD, FRCS(C)

  Panam Clinic Orthopedics and Sports Medicine/University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head, Orthopaedics

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: April 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 27, 2015
• Results First Posted: May 9, 2014

Record last verified: 2015-03

Locations

CA (1)