Outcome Following Surgery to Repair Rotator Cuff Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00260949
First received: November 30, 2005
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

There are two ways in which surgeons repair rotator cuff tears. An open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. This clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique.


Condition Intervention Phase
Rotator Cuff Tear
Procedure: Arthroscopic repair of rotator cuff tear
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional and Anatomical Results Following Arthroscopic Cuff Repair

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Rate of re-tear at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcome Anatomical integrity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2004
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Arthroscopic repair of rotator cuff tear
    Patients will undergo arthroscopic shoulder surgery in the standard fashion
Detailed Description:

While many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. Arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. Once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via Magnetic Resonance Imaging (MRI) between the two techniques. If the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. If, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness2) ability to illicit pain or weakness with one of the following signs: tenderness of the rotator cuff insertion, palpable crepitus of the subacromial bursa or a palpable defect of the cuff insertion, impingement signs and weakness of the rotator cuff musculature3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or MRI2. Failed non-operative treatment3. Size of tear of less than 5 cm and involving 2 or fewer tendons

Exclusion Criteria:

  • Clinical:1. Tear as defined by significant muscular wasting, inability to actively forward-flex (strength grade 2/5 or worse), positive drop sign or hornblowers 2. Significant tenderness of acromioclavicular or sternoclavicular joints on affected side3. Presence of comorbid shoulder instability or evidence of SLAP lesion4. Previous surgery on affected shoulderRadiological:1. Bony abnormality on standardized series of x-rays consisting of a minimum of an antero-posterior view, lateral “Y” view in the scapular plane, and an axillary view.2. Presence of massive cuff tear on MRI or ultrasound (defined as > 5 cm or greater than 2 tendons torn).Arthroscopic:1. Presence of massive cuff tear as defined above on arthroscopic examination of the joint 2. Presence of comorbid conditions: Bankart lesion, SLAP lesion3. Inability to complete the repair arthroscopically (eg. partial repair by marginal convergence without direct repair to bone)Other:Patients who have any contraindication to MRI (including claustrophobia, intracranial aneurism clip, cardiac pacemaker, middle ear prosthesis, metallic heart valve prosthesis, prior metal fragment in eye (intraocular lens implant) etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260949

Locations
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: {Peter Lapner OHRI
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00260949     History of Changes
Other Study ID Numbers: OHREB 2003534-01H
Study First Received: November 30, 2005
Last Updated: October 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
rotator cuff tear
arthroscopic repair

ClinicalTrials.gov processed this record on August 28, 2014