Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear; Acromial Spur	Procedure: Rotator Cuff Repair and Subacromial Decompression; Other: Questionnaire	Not Applicable

Detailed Description:

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Randomized Single Blinded Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
Study Start Date :	August 2011
Estimated Primary Completion Date :	August 2012
Estimated Study Completion Date :	August 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: A; Subacromial decompression before repair of a complete rotator cuff tear.	Procedure: Rotator Cuff Repair and Subacromial Decompression; Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date. Other: 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.
Active Comparator: B; Subacromial decompression after repair of a complete rotator cuff repair.	Procedure: Rotator Cuff Repair and Subacromial Decompression; Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date. Other: 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Pre and Post Surgery Pain and Satisfaction [ Time Frame: 1 year ]
   Both arms will complete an identical baseline and post-operative pain and functionality survey. The data will be analyzed to determine the rate of change between the pre and post surgery results. The results from the two groups will be compared to determine if there is a significant difference in pain and functionality between subjects in Arm A and Arm B.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Stephen Nystrom, DO	810-606-5000	stephen.nystrom@genesys.org
Contact: Lauren E Suchy, MPA	810-606-7878	lauren.suchy@genesys.org

Locations

United States, Michigan
Genesys Regional Medical Center-General Surgery Center	Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Stephen Nystrom, DO 810-606-5000
Principal Investigator: Stephen Nystrom, DO
Greater Flint Sports Medicine	Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Stephen Nystrom, DO 810-606-5000 stephen.nystrom@genesys.org
Principal Investigator: Stephen Nystrom, DO

Sponsors and Collaborators

Genesys Regional Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lauren Suchy, Academic Research Coordinator, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:	NCT01430598 History of Changes
Other Study ID Numbers:	ME 11 0021
First Posted:	September 8, 2011
Last Update Posted:	September 8, 2011
Last Verified:	September 2011

Keywords provided by Lauren Suchy, Genesys Regional Medical Center:

Full Thickness Rotator Cuff Tear and Acromial Spur

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries