Clinical trial
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
Name
FAI_DM
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).
Trial arms
Trial start
2021-05-28
Estimated PCD
2023-11-30
Trial end
2023-12-20
Status
Completed
Treatment
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Anti-inflammatory and regenerative effect, 5 mg/ml
Arms:
Hydrolyzed Collagen Peptides
Cortisone
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Arms:
Cortisone (C)
Size
25
Primary endpoint
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.
Pre-operative; 1 and 6 months post-operative
Visual Analogue Scale (VAS)
Pre-operative; 1 and 6 months post-operative
Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)
Pre-operative; 1 and 6 months post-operative
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-01-30
1 organization
1 product
4 indications
Organization
Istituto Ortopedico RizzoliProduct
CortisoneIndication
Femoroacetabular ImpingementIndication
Hip ArthroscopyIndication
Osteoarthritis, HipIndication
Collagen Hydrolysate