Clinical trial NCT06082271: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Hip Arthroscopy
Hip Osteoarthritis
Hydrolyzed Collagen Peptides
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Eleonora Olivotto
First posted: 2023-10-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Pre-operative; 1 and 6 months post-operative
measure: Visual Analogue Scale (VAS)
timeFrame: Pre-operative; 1 and 6 months post-operative
measure: Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)
timeFrame: Pre-operative; 1 and 6 months post-operative
Secondary outcomes:
measure: Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes
timeFrame: Pre-operative; 1 and 6 months post-operative
measure: Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain
timeFrame: Pre-operative; 1 and 6 months post-operative
measure: Differences between the two study groups
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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