Status:
COMPLETED
Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
Lead Sponsor:
Istituto Ortopedico Rizzoli
Collaborating Sponsors:
Eleonora Olivotto
Conditions:
Femoroacetabular Impingement
Hip Arthroscopy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Hip Osteoarthritis (HOA) is the most common joint disorder and a major cause of disability in the adult population. Thus, the early diagnosis, prevention, and treatment of the early stages of the dise...
Detailed Description
Patients scheduled for hip arthroscopy for treatment of FAI and/or labral pathology will be enrolled. The two treatments, C or P, will be administrated to patients with random sampling. SFs samples, w...
Eligibility Criteria
Inclusion
- candidates for hip arthroscopy for femoroacetabular impingement (FAI)
- ability to provide informed consent
Exclusion
- inability to provide informed consent;
- patients suffering from cancer or with poor general health conditions;
- patients suffering from coagulation diseases;
- positive history of tumor, infection, rheumatic or metabolic disease in the joint undergoing surgery;
- systemic inflammatory rheumatic diseases;
- pregnant or breastfeeding women;
- patients with proven hypersensitivity to collagen of bovine origin or vitamin C.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06082271
Start Date
May 28 2021
End Date
December 20 2023
Last Update
January 30 2024
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136