Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/2/2016 |
Start Date: | August 2011 |
End Date: | August 2012 |
Contact: | Stephen Nystrom, DO |
Email: | stephen.nystrom@genesys.org |
Phone: | 810-606-5000 |
Randomized Single Blinded Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
The investigators aim to establish whether completing a subacromial decompression before or
after repair of a complete rotator cuff tear has any clinical significance. Both the
arthroscopic decompression and rotator cuff repair will be completed during the same
surgical date. The investigators null hypothesis contends that full-thickness rotator cuff
tear repair performed before versus after subacromial decompression will not influence
patient's post-operative pain or functionality.
after repair of a complete rotator cuff tear has any clinical significance. Both the
arthroscopic decompression and rotator cuff repair will be completed during the same
surgical date. The investigators null hypothesis contends that full-thickness rotator cuff
tear repair performed before versus after subacromial decompression will not influence
patient's post-operative pain or functionality.
All patients with a diagnosed full thickness rotator cuff tear and symptomatic subacromial
decompression will be consulted about arthroscopic subacromial decompression and rotator
cuff repair. The possible risks and benefits will be discussed with the patient in detail by
the operating surgeon. If a patient agrees to undergo surgical intervention (i.e.
arthroscopic subacromial decompression and rotator cuff repair in the same surgical
setting), they will be approached and informed regarding involvement in the study. This is a
single blind study so participants will not know into which arm they have been randomized.
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.
decompression will be consulted about arthroscopic subacromial decompression and rotator
cuff repair. The possible risks and benefits will be discussed with the patient in detail by
the operating surgeon. If a patient agrees to undergo surgical intervention (i.e.
arthroscopic subacromial decompression and rotator cuff repair in the same surgical
setting), they will be approached and informed regarding involvement in the study. This is a
single blind study so participants will not know into which arm they have been randomized.
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.
Inclusion Criteria:
- Aged 18-65
- 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:
- Patient with radiographic evidence of glenohumeral degenerative joint disease or
rotator cuff arthropathy
- 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
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