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

November 30, 2005
October 24, 2011
November 2004
August 2011   (final data collection date for primary outcome measure)
Rate of re-tear at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Rate of re-tear at 1 year
Complete list of historical versions of study NCT00260949 on ClinicalTrials.gov Archive Site
Functional outcome Anatomical integrity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Functional outcome Anatomical integrity
Not Provided
Not Provided
 
Outcome Following Surgery to Repair Rotator Cuff Tears
Functional and Anatomical Results Following Arthroscopic Cuff Repair

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rotator Cuff Tear
Procedure: Arthroscopic repair of rotator cuff tear
Patients will undergo arthroscopic shoulder surgery in the standard fashion
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00260949
OHREB 2003534-01H
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: {Peter Lapner OHRI
Ottawa Hospital Research Institute
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP