Recruiting

Arthroscopic Decompression

Sponsor:

Ascension Health

Code:

NCT01430598

Conditions

Rotator Cuff Tear

Acromial Spur

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Rotator Cuff Repair and Subacromial Decompression

Questionnaire

Study Details

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.

Conditions

Rotator Cuff Tear

Acromial Spur

Study ID

NCT01430598

Start date

Aug, 2011

Status verified date

Sep, 2011

Completion date

Aug, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: A

Subacromial decompression before repair of a complete rotator cuff tear.

active comparator: B

Subacromial decompression after repair of a complete rotator cuff repair.

Interventions

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.

Primary outcome measure

  • Pre and Post Surgery Pain and Satisfaction [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Stephen Nystrom, DO

810-606-5000stephen.nystrom@genesys.org

Lauren E Suchy, MPA

810-606-7878lauren.suchy@genesys.org

Locations

Genesys Regional Medical Center-General Surgery Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Stephen Nystrom, DO

810-606-5000

Principal Investigator:

Stephen Nystrom, DO

Greater Flint Sports Medicine

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Stephen Nystrom, DO

810-606-5000stephen.nystrom@genesys.org

Principal Investigator:

Stephen Nystrom, DO

More Information

Sponsor

Ascension Health

Last update posted

Sep 8, 2011

Last verified

Sep, 2011

Keywords

  • Full Thickness Rotator Cuff Tear and Acromial Spur

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascension Health on 2011-09-08.