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

• Status: Completed
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

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 disease and of the pre-arthritic condition, in particular in adolescents and young adults, is crucial to reducing the incidence of end-stage HOA and the need for total hip replacement (THR).

Evidence has mounted for a prominent etiologic role of femoroacetabular impingement (FAI) in the development of early HOA leading to the development of early cartilage and labral damage in the non-dysplastic hip. Therefore, the surgical treatment of FAI with mini-invasive arthroscopy is crucial. To improve the outcome after surgery, cortisone is routinely injected during the procedure for anti-inflammatory purposes.

The aim of the study is to compare the use of cortisone (gold-standard) (C) to a new class III medical device based on hydrolysed Collagen Peptides PEP-52, Peptys (P) and to investigate potential associations among the preoperative symptoms and hip function, the outcomes after arthroscopic surgery and biomarkers in synovial fluids (SFs).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Ortopedico Rizzoli
• Collaborator: Eleonora Olivotto
• Treatments: Cortisone

Criteria

Inclusion Criteria:

• candidates for hip arthroscopy for femoroacetabular impingement (FAI)

• ability to provide informed consent

Exclusion Criteria:

• 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.