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

Not Applicable

Completed

• Conditions: Hip Arthroscopy; Femoroacetabular Impingement; Hip Osteoarthritis; Hydrolyzed Collagen Peptides
• Interventions: Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys); Drug: Cortisone

• Registration Number: NCT06082271
• Lead Sponsor: Istituto Ortopedico Rizzoli

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 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).

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, 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.

Study Timeline

• Study Start: 2021-05-28
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrolyzed Collagen Peptides	Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)	The use is alternative to cortisone
Cortisone (C)	Cortisone	To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.

Primary Outcome Measures

Name	Time	Method
Hip disability & Osteoarthritis Outcome Score (HOOS) has five domains (pain, symptoms, activities of daily living, sports, recreational activities, quality of life): higher scores better hip function.	Pre-operative; 1 and 6 months post-operative	Investigate the preoperative symptoms and hip function
Visual Analogue Scale (VAS)	Pre-operative; 1 and 6 months post-operative	Investigate the preoperative hip pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)	Pre-operative; 1 and 6 months post-operative	Investigate the degenerative changes to the hip. The score consists of three progressive degrees: 0 no osteoarthritis; form 1 to 3 increasing the degeneration.

Secondary Outcome Measures

Name	Time	Method
Differences between the two study groups	6 months post-operative	Evaluate the differences between group I and group I+P in the clinical and functional outcome and in the use of analgesics
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes	Pre-operative; 1 and 6 months post-operative	Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative HOOS in both groups and the presence of collagen degradation products in the urine in the pre-operative
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain	Pre-operative; 1 and 6 months post-operative	Evaluation of the correlation between the presence of inflammatory molecules in the pre-operative synovial fluid and the post-operative pain score VAS in both groups and the presence of collagen degradation products in the urine in the pre-operative

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy