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

Completed NA Last updated 30 January 2024

What this trial tests

NA trial testing Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys) in Femoroacetabular Impingement in 25 participants. Completed in 20 December 2023.

Timeline

28 May 2021

Primary endpoint
30 November 2023

20 December 2023

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	28 May 2021
Primary completion	30 November 2023
Estimated completion	20 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
• Cortisone (CORTISONE) — full drug profile →

Conditions studied

• Femoroacetabular Impingement — all drugs for Femoroacetabular Impingement →
• Hip Arthroscopy — all drugs for Hip Arthroscopy →
• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
• Hydrolyzed Collagen Peptides — all drugs for Hydrolyzed Collagen Peptides →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 65, any sex, with Femoroacetabular Impingement or Hip Arthroscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-operative injection of hydrolyzed collagen peptides shows anti-inflammatory effect in patients with femoroacetabular impingement improving the early recovery.
   Tassinari E, Minerba A, Basile T, Bucciarelli A, et al · · 2025 · cited 1× · PMID 39896095 · DOI 10.1002/jeo2.70158