Outcome Following Surgery to Repair Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

Official title:

Functional and Anatomical Results Following Arthroscopic Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260949
• Other study ID #: 2003534-01H
• Status: Completed
• Start date: November 2004
• Est. completion date: September 2011

Study information

• Verified date: April 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. 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

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• Arthroscopic repair of rotator cuff tear
Patients will undergo arthroscopic shoulder surgery in the standard fashion

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & 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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Status Anatomical integrity	Overall functional status will be assessed by the American Shoulder and Elbow Surgeons (ASES), which is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome. Functional status will also be assessed using The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points. The test is divided into four sub-categories: (1) pain (2) activities of daily living ability; (3) mobility; (4) strength. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).	1 year