Status:
COMPLETED
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Panam Clinic
London Health Sciences Centre
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination."Trephination" is a procedure that involves making small perforations in the bone tha...
Detailed Description
Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in ter...
Eligibility Criteria
Inclusion
- Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
- The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
- Activity modification
- Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.
Exclusion
- Characteristics of the cuff tear that render the cuff irrepairable:
- fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
- Partial thickness cuff tears.
- Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
- Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
- Isolated subscapularis tendon tears
- Active joint or systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- Charcot's arthropathy
- Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
- Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
- Unable to speak or read English/French
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 24 months
- Advanced physiologic age
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01877772
Start Date
June 1 2013
End Date
January 1 2022
Last Update
March 3 2023
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6