N/A
Completed N=86
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Rotator cuff tear · Shoulder Impingement Syndrome
Source: ClinicalTrials.gov NCT00290888 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Western Ontario Rotator Cuff Index (WORC) — 80.5; 86.7 percentage of total score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario Rotator Cuff Index (WORC) |
80.5; 86.7 | — |
| PRIMARY American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) |
84.6; 89.8 | — |
| SECONDARY Shoulder Range of Motion |
— | — |
| SECONDARY Upper Extremity Strength Grading |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00290888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.