Status:

COMPLETED

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

Lead Sponsor:

Istituto Ortopedico Rizzoli

Collaborating Sponsors:

Eleonora Olivotto

Conditions:

Femoroacetabular Impingement

Hip Arthroscopy

Eligibility:

All Genders

18-65 years

Phase:

NA

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 dise...

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, w...

Eligibility Criteria

Inclusion

  • candidates for hip arthroscopy for femoroacetabular impingement (FAI)
  • ability to provide informed consent

Exclusion

  • 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.

Key Trial Info

Start Date :

May 28 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2023

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT06082271

Start Date

May 28 2021

End Date

December 20 2023

Last Update

January 30 2024

Active Locations (1)

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1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136