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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACR | Active Comparator | Arthroscopic rotator cuff repair without acromioplasty |
|
| ACR-A | Experimental | Arthorscopic rotator cuff repair with acromioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acromioplasty | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Range of Motion | 24 months | |
| Upper Extremity Strength Grading | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter MacDonald, MD, FRCS(C) | Panam Clinic Orthopedics and Sports Medicine/University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panam Clinic | Winnipeg | Manitoba | R3M 3E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9850776 | Background | 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. | |
| 7726359 | 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. |
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A total of 86 patients were randomized to either ACR-A or ACR
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| ID | Title | Description |
|---|---|---|
| FG000 | Arthroscopic Rotator Cuff Repair Without Acromioplasty | ACR Acromioplasty |
| FG001 | Arthorscopic Rotator Cuff Repair With Acromioplasty | ACR-A Acromioplasty |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic rotator cuff repair without acromioplasty (ACR) |
| BG001 | Arthroscopic Rotator Cuff Repair With Acromioplasty |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Western Ontario Rotator Cuff Index (WORC) | Calculated as percentage with an increase in score indicating an improvement in outcome. | Posted | Mean | Standard Deviation | percentage of total score | 24 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arthroscopic Rotator Cuff Repair Without Acromioplasty | ACR |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter MacDonald | Pan Am Clinic | 204-925-7480 | pmacdonald@panamclinic.com |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| 8902127 | 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. |
| 8196974 | Background | Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62. |
| 9611036 | 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. |
| 9276051 | 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. |
| 8421609 | Background | Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71. |
| 2009126 | 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. |
| 4019548 | Background | Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available. |
| 8358901 | 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. |
| 8461081 | 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. |
| 5054450 | 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. |
Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of total score | 24 months |
|
|
|
| Secondary | Shoulder Range of Motion | Not Posted | 24 months |
| Secondary | Upper Extremity Strength Grading | Not Posted | 24 months |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Arthroscopic Rotator Cuff Repair With Acromioplasty | ACR-A Acromioplasty | 0 | 45 | 0 | 45 |
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |