Status:
NOT_YET_RECRUITING
Outcomes of Massive Rotator Cuff Tendon Tear Treatment.
Lead Sponsor:
Tartu University Hospital
Collaborating Sponsors:
University of Tartu
Conditions:
Rotator Cuff Tears
Rotator Cuff Syndrome
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable ...
Detailed Description
Patients with massive rotator cuff tendon tears aged between 50 to 80 years will be included in the study following the eligibility criteria. Massive tear is defined as grade III tear according to Dav...
Eligibility Criteria
Inclusion
- Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.
- Primary rotator cuff pathology AND
- Symptoms have not lasted more than 6 months.
- In case of trauma, traumatic event no more than 6 months ago.
- Aged between 50 and 80 at the time of enrollment.
- Subject is able and willing to give informed consent AND
- Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits.
Exclusion
- Previous rotator cuff surgery of the index shoulder.
- Acute or chronic osteomyelitis.
- Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).
- Uncontrolled diabetes.
- Active oncological disease.
- Radiologically stage IV shoulder joint arthrosis (rotator cuff arthropathy).
- Systemic or intra-articular corticosteroid therapy less than 60 days prior to planned operation date.
- Intramuscular or peroral corticosteroid treatment less than 30 days prior to planned operation date.
- Acute or chronic conditions that are contraindications for functional testing.
- MRI contraindicated.
- Substance or alcohol abuse.
- Refusal or withdrawal of consent.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06016439
Start Date
January 1 2024
End Date
December 1 2033
Last Update
November 24 2023
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