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

Primary Purpose

Rotator Cuff Tear, Acromial Spur

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotator Cuff Repair and Subacromial Decompression
Questionnaire
Sponsored by
Ascension Genesys Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Full Thickness Rotator Cuff Tear and Acromial Spur

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Genesys Regional Medical Center-General Surgery CenterRecruiting
  • Greater Flint Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Subacromial decompression before repair of a complete rotator cuff tear.

Subacromial decompression after repair of a complete rotator cuff repair.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2011
Last Updated
September 7, 2011
Sponsor
Ascension Genesys Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01430598
Brief Title
Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ascension Genesys Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Acromial Spur
Keywords
Full Thickness Rotator Cuff Tear and Acromial Spur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Subacromial decompression before repair of a complete rotator cuff tear.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Subacromial decompression after repair of a complete rotator cuff repair.
Intervention Type
Procedure
Intervention Name(s)
Rotator Cuff Repair and Subacromial Decompression
Intervention Description
Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre and Post Surgery Pain and Satisfaction
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Nystrom, DO
Phone
810-606-5000
Email
stephen.nystrom@genesys.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren E Suchy, MPA
Phone
810-606-7878
Email
lauren.suchy@genesys.org
Facility Information:
Facility Name
Genesys Regional Medical Center-General Surgery Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Nystrom, DO
Phone
810-606-5000
First Name & Middle Initial & Last Name & Degree
Stephen Nystrom, DO
Facility Name
Greater Flint Sports Medicine
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Nystrom, DO
Phone
810-606-5000
Email
stephen.nystrom@genesys.org
First Name & Middle Initial & Last Name & Degree
Stephen Nystrom, DO

12. IPD Sharing Statement

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

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