Outcome Following Surgery to Repair Rotator Cuff Tears
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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 |
- Rate of re-tear at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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) |
-
Procedure: Arthroscopic repair of rotator cuff tear
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 |
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
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 June 18, 2013