Outcome Following Surgery to Repair Rotator Cuff Tears

NCT00260949 | Terminated

• 1 other identifier: 2003534-01H
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tear; arthroscopic repair

Outcome Measures

Primary Outcomes (1)

• Rate of re-tear at 1 year

  The rate of rotator cuff re-tear will be measured 1-year post-operatively using a Magnetic Resonance Imaging (MRI) Arthrogram.

  1 year

Secondary Outcomes (1)

• Functional Status Anatomical integrity

  1 year

Interventions

Arthroscopic repair of rotator cuff tear PROCEDURE

Patients will undergo arthroscopic shoulder surgery in the standard fashion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be screened by participating surgeons in a fellowship-run outpatient shoulder clinic. Patients who have consented and are scheduled to undergo an arthroscopic rotator cuff repair, and who have a cuff tear size of \<5 cm, and involving 2 or fewer tendons, and meet the additional eligibility criteria will be approached to join the study.

You may qualify if:

• \. Diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness 2) 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 musculature 3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or MRI. Failed non-operative treatment. Size of tear of less than 5 cm and involving 2 or fewer tendons

You may not qualify if:

• 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 \&#8220;Y\&#8221; view in the scapular plane, and an axillary view.2. Presence of massive cuff tear on MRI or ultrasound (defined as \&gt; 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (1)

• Lapner PC, Su Y, Simon D, El-Fatori S, Lopez-Vidriero E. Does the upward migration index predict function and quality of life in arthroscopic rotator cuff repair? Clin Orthop Relat Res. 2010 Nov;468(11):3063-9. doi: 10.1007/s11999-010-1457-7. Epub 2010 Jul 7.

  PMID: 20607465 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Peter Lapner

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 2, 2005
• Study Start: November 1, 2004
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CA (1)