Status:
UNKNOWN
Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Glenohumeral Arthritis
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
In the non-weight bearing glenohumeral joint, focal chondral defects are encountered infrequently and are usually found in association with other pathologies, such as glenohumeral instability, postope...
Detailed Description
This study is a prospective, therapeutic open blind randomized study. The enrollment of the patients will start immediately after the ethical committee approval. Considering our cases and our experien...
Eligibility Criteria
Inclusion
- Age between 50-70 years.
- Arthroscopic surgery for rotator cuff disorders.
- Arthroscopic findings of ICRS grade 2 or 3 chondropathy.
- Ability to give informed consent according to the International Conference of Harmonization (ICH)-Good Clinical Practices (GCP), and national/local regulations.
Exclusion
- Patients with a diagnosis of osteoarthritis before surgery.
- Patients with ICRS grade 4 chondropathy.
- Patients who received subacromial decompression.
- Patients who received biceps tenodesis after tenotomy
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04309344
Start Date
November 19 2019
End Date
January 31 2021
Last Update
March 16 2020
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089