An interventional study of Acromioplasty in Rotator Cuff Tear and Shoulder Impingement Syndrome, sponsored by Panam Clinic. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-27.
Sponsored by Panam Clinic · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 86 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →Panam Clinic is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Arthroscopic rotator cuff repair without acromioplasty
Procedure: Acromioplasty
Arthorscopic rotator cuff repair with acromioplasty
Procedure: Acromioplasty
Western Ontario Rotator Cuff Index (WORC)
Calculated as percentage with an increase in score indicating an improvement in outcome.
Time frame: 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.
Time frame: 24 months
Shoulder Range of Motion
Time frame: 24 months
Upper Extremity Strength Grading
Time frame: 24 months
A total of 86 patients were randomized to either ACR-A or ACR
| Milestone | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthorscopic Rotator Cuff Repair With Acromioplasty |
|---|---|---|
| Started | 41 | 45 |
| Completed | 38 | 44 |
| Not completed | 3 | 1 |
| Withdrew: Physician decision | 3 | 1 |
Calculated as percentage with an increase in score indicating an improvement in outcome.
| percentage of total score | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | 80.5 ± 22.3 | 86.7 ± 16.2 |
Calculated as a percentage with an increase in score reflecting an improvement in outcome.
| percentage of total score | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthorscopic Rotator Cuff Repair With Acromioplasty |
|---|---|---|
| American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) | 84.6 ± 20.1 | 89.8 ± 14.4 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arthroscopic Rotator Cuff Repair Without Acromioplasty | — | 0/41 (0%) | 0/41 (0%) |
| Arthroscopic Rotator Cuff Repair With Acromioplasty | — | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty | Total |
|---|---|---|---|
| Mean | 57.1 ± 9.5 | 56.2 ± 7.9 | 56.7 ± 8.7 |
| Age, Categorical(Participants) | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 45 | 86 |
| >=65 years | 0 | 0 | 0 |
| Gender(participants) | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 30 | 24 | 54 |
| Region of Enrollment(participants) | Arthroscopic Rotator Cuff Repair Without Acromioplasty | Arthroscopic Rotator Cuff Repair With Acromioplasty | Total |
|---|---|---|---|
| Canada | 41 | 45 | 86 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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