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NCT Number: 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

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).

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Key information

Conditions

Femoroacetabular Impingement Arthritis Femoracetabular Impingement Hip Arthroscopy Hip Osteoarthritis Hydrolyzed Collagen Peptides Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Anti-inflammatory and regenerative effect, 5 mg/ml

Cortisone

Drug

DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml

Primary outcomes

  1. 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.

    Time frame: Pre-operative; 1 and 6 months post-operative

    Investigate the preoperative symptoms and hip function

  2. Visual Analogue Scale (VAS)

    Time frame: 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.

  3. Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)

    Time frame: 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 outcomes

  1. Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes

    Time frame: 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

  2. Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain

    Time frame: 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

  3. Differences between the two study groups

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Eleonora Olivotto

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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