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
Condition: Femoroacetabular Impingement; Hip Arthroscopy; Hip Osteoarthritis; Hydrolyzed Collagen Peptides
MeSH terms: Osteoarthritis, Hip; Femoracetabular Impingement
Study type: Interventional

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.
    

Intervention name(s): Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys); Cortisone
Intervention type(s): Device; Drug
Intervention description(s): Anti-inflammatory and regenerative effect, 5 mg/ml; DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Treatment