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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Hip Arthroscopy; Hip Osteoarthritis; Femoroacetabular Impingement; Hydrolyzed Collagen Peptides

Treatments: Drug: Cortisone; Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)

Study type: Interventional

Funder types: Other

Identifiers

NCT06082271

FAI_DM

Details and patient eligibility

About

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).

Full 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, when available, are obtained by aspiration just prior to surgical intervention, collected and stored for biomarkers analysis.

At the baseline, OA severity will be assessed with a radiographic scoring system (Tönnis classification). Physical examination and clinical assessment using the Hip disability & Osteoarthritis Outcome Score (HOOS) and VAS score for pain will be performed at the time of surgery and at 1-6 months of follow up. At the time of surgery, chondral (Outerbridge score) and labral pathology based on direct arthroscopic visualization will be also evaluated.

The presence of inflammatory molecules at the baseline in the SFs will be also evaluated.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Cortisone (C)

Active Comparator group

Description:

To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.

Treatment:

Drug: Cortisone

Hydrolyzed Collagen Peptides

Experimental group

Description:

The use is alternative to cortisone

Treatment:

Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)