Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
NCT ID: NCT01430598
Last Updated: 2011-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-08-31
2012-08-31
Brief Summary
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Detailed Description
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Once consented, the subject will be randomized into one of two treatment arms. Those in Arm A will have subacromial decompression before repair of a complete rotator cuff and those in Arm B will have subacromial decompression after repair of a complete rotator cuff.
Prior to surgical intervention all patients will complete two separate questionnaires in the waiting room. The results of the questionnaires will be later used to compare pre-operative and post-operative changes following shoulder surgery.
On the date of surgery, the operative surgeon will ensure a full-thickness rotator cuff tear is present with an associated acromial spur. If both are present, the operative surgeon will perform the surgical intervention in the previously assigned order according to the patient's treatment arm. All acromial spurs will be burred to a level flush with the remaining non-pathologic acromion. The full-thickness rotator cuff will be repaired utilizing sutures and suture anchors. The specific pattern of repair will be determined intra-operatively. This is standard procedure for arthroscopic rotator cuff repair and subacromial decompression. There is no known risks within the orthopedic literature with performing subacromial decompression before versus after rotator cuff repair. As such, this study aims to identify any significance of the order of surgery if it exists.
Post-operatively all patients will be placed within a Berg SlingShot®. All patients will undergo a period of immobilization within the sling. Patients will be evaluated at 2 weeks, 6 weeks, and 12 weeks post-operatively. The shoulder range of motion and relative strength, compared to the contralateral limb, will be assessed. They will be prescribed formal physical therapy in the outpatient setting. At the 12 week visit each subject will complete the questionnaires once again. The scores will be tabulated and inserted in the Excel spreadsheet.
The pre-operative and post-operative scores will be compared. The change in score from each treatment arm will be averaged and analyzed for statistically significant difference. Also, the pre- and post-operative forward flexion, abduction range of motion will be compared. The external and internal rotation strengths will be compared from the pre- and post-operative evaluations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
Subacromial decompression before repair of a complete rotator cuff tear.
Rotator Cuff Repair and Subacromial Decompression
Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
Questionnaire
Patients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery.
B
Subacromial decompression after repair of a complete rotator cuff repair.
Rotator Cuff Repair and Subacromial Decompression
Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
Questionnaire
Patients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery.
Interventions
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Rotator Cuff Repair and Subacromial Decompression
Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
Questionnaire
Patients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic patients with MRI positive full thickness rotator cuff tears
* Clinically and/or radiographically positive subacromial impingement/spur with associated rotator cuff tendonitis and bursitis
* Patients who have failed outpatient conservative therapy, including, but not limited to physical therapy and subacromial injection with steroid and local anesthetic
Exclusion Criteria
* Patients with a prior history of joint sepsis
* Patients who have had previous shoulder surgery on the anticipated operative limb
* Patients with a diagnosed pathology causing associated pain and/or weakness to the anticipated operative limb
* Patient deemed unable to complete the post-operative rehabilitation protocol
* Patients diagnosed, either intra-operatively or by MRI, as having irreparable rotator cuff tears
18 Years
65 Years
ALL
No
Sponsors
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Ascension Health
INDUSTRY
Responsible Party
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Lauren Suchy
Academic Research Coordinator
Locations
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Genesys Regional Medical Center-General Surgery Center
Grand Blanc, Michigan, United States
Greater Flint Sports Medicine
Grand Blanc, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Stephen Nystrom, DO
Role: primary
Other Identifiers
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ME 11 0021
Identifier Type: -
Identifier Source: org_study_id
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