NCT00290888|CompletedResults
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Sponsor study identifier
interventional
86
1 country
1
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2006
Actual (reported)February 13, 2006
Actual (reported)March 2011
Actual (reported)March 2011
Actual (reported)May 9, 2014
Actual (reported)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
Shoulder Range of Motion
24 months
Upper Extremity Strength Grading
24 months
Arthroscopic rotator cuff repair without acromioplasty
Arthorscopic rotator cuff repair with acromioplasty
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Panam Clinic
Winnipeg, Manitoba, R3M 3E4, Canada
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.
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.
Peter MacDonald, MD, FRCS(C)
Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
86 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2006
First Posted
February 13, 2006
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Contact the study team to confirm eligibility.
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.
Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)Last Updated
March 27, 2015
Results First Posted
May 9, 2014
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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