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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear; Acromial Spur
• Intervention / Treatment: Procedure: Rotator Cuff Repair and Subacromial Decompression; Other: Questionnaire

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Nystrom, DO; Phone Number: 810-606-5000; Email: stephen.nystrom@genesys.org
• Study Contact Backup: Name: Lauren E Suchy, MPA; Phone Number: 810-606-7878; Email: lauren.suchy@genesys.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre and Post Surgery Pain and Satisfaction	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.	1 year

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): August 1, 2012
• Study Completion (ANTICIPATED): August 1, 2012

Study Registration Dates

• First Submitted: August 29, 2011
• First Submitted That Met QC Criteria: September 7, 2011
• First Posted (ESTIMATE): September 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 8, 2011
• Last Update Submitted That Met QC Criteria: September 7, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Full Thickness Rotator Cuff Tear and Acromial Spur
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: ME 11 0021