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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Femoroacetabular Impingement, Hip Arthroscopy, Hip Osteoarthritis, Hydrolyzed Collagen Peptides

Intervention / Treatment
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* Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
* Drug: Cortisone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients scheduled for hip arthroscopy for treatment of FAI and/or labral pathology were enrolled. The two treatments, cortisone (gold standard) or collagen Pepetids, were administrated to patients intraoperatively with random sampling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cortisone (C)<br>To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure. | Drug: Cortisone<br>* DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml<br>|
| Experimental: Hydrolyzed Collagen Peptides<br>The use is alternative to cortisone | Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)<br>* Anti-inflammatory and regenerative effect, 5 mg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Investigate the preoperative symptoms and hip function | Pre-operative; 1 and 6 months post-operative | 
| Visual Analogue Scale (VAS) | 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. | Pre-operative; 1 and 6 months post-operative | 
| Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification) | Investigate the degenerative changes to the hip. The score consists of three progressive degrees: 0 no osteoarthritis; form 1 to 3 increasing the degeneration. | Pre-operative; 1 and 6 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes | 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 | Pre-operative; 1 and 6 months post-operative | 
| Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain | 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 | Pre-operative; 1 and 6 months post-operative | 
| Differences between the two study groups | Evaluate the differences between group I and group I+P in the clinical and functional outcome and in the use of analgesics | 6 months post-operative |