search
Back to results

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

Primary Purpose

Rotator Cuff Tear, Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acromioplasty
Sponsored by
Panam Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Panam Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACR

ACR-A

Arm Description

Arthroscopic rotator cuff repair without acromioplasty

Arthorscopic rotator cuff repair with acromioplasty

Outcomes

Primary Outcome Measures

Western Ontario Rotator Cuff Index (WORC)
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)
Calculated as a percentage with an increase in score reflecting an improvement in outcome.

Secondary Outcome Measures

Shoulder Range of Motion
Upper Extremity Strength Grading

Full Information

First Posted
February 10, 2006
Last Updated
March 9, 2015
Sponsor
Panam Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT00290888
Brief Title
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Official Title
Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panam Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Shoulder Impingement Syndrome
Keywords
Rotator Cuff Tear, Tendon Repair, Acromioplasty, Arthroscopy, Orthopedic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACR
Arm Type
Active Comparator
Arm Description
Arthroscopic rotator cuff repair without acromioplasty
Arm Title
ACR-A
Arm Type
Experimental
Arm Description
Arthorscopic rotator cuff repair with acromioplasty
Intervention Type
Procedure
Intervention Name(s)
Acromioplasty
Primary Outcome Measure Information:
Title
Western Ontario Rotator Cuff Index (WORC)
Description
Calculated as percentage with an increase in score indicating an improvement in outcome.
Time Frame
24 months
Title
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Description
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Shoulder Range of Motion
Time Frame
24 months
Title
Upper Extremity Strength Grading
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter MacDonald, MD, FRCS(C)
Organizational Affiliation
Panam Clinic Orthopedics and Sports Medicine/University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panam Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
9850776
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. doi: 10.1177/03635465980260060501.
Results Reference
background
PubMed Identifier
7726359
Citation
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.
Results Reference
background
PubMed Identifier
8902127
Citation
Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9. doi: 10.1016/s0749-8063(96)90192-9.
Results Reference
background
PubMed Identifier
8196974
Citation
Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.
Results Reference
background
PubMed Identifier
9611036
Citation
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.
Results Reference
background
PubMed Identifier
9276051
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. doi: 10.1016/s0749-8063(97)90123-7.
Results Reference
background
PubMed Identifier
8421609
Citation
Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71.
Results Reference
background
PubMed Identifier
2009126
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. doi: 10.1016/0749-8063(91)90071-5.
Results Reference
background
PubMed Identifier
4019548
Citation
Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
Results Reference
background
PubMed Identifier
8358901
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.
Results Reference
background
PubMed Identifier
8461081
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. doi: 10.1016/s0749-8063(05)80374-3.
Results Reference
background
PubMed Identifier
5054450
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. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs