An interventional study of Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys) and Cortisone in Femoroacetabular Impingement, Hip Arthroscopy and Hip Osteoarthritis, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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).
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 25 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.
Drug: Cortisone
The use is alternative to cortisone
Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Anti-inflammatory and regenerative effect, 5 mg/ml
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
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.
Investigate the preoperative symptoms and hip function
Time frame: Pre-operative; 1 and 6 months post-operative
Visual Analogue Scale (VAS)
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.
Time frame: Pre-operative; 1 and 6 months post-operative
Osteoarthtitis severity assessed with radiographic scoring system (Tönnis classification)
Investigate the degenerative changes to the hip. The score consists of three progressive degrees: 0 no osteoarthritis; form 1 to 3 increasing the degeneration.
Time frame: Pre-operative; 1 and 6 months post-operative
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes
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
Time frame: Pre-operative; 1 and 6 months post-operative
Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain
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
Time frame: Pre-operative; 1 and 6 months post-operative
Differences between the two study groups
Evaluate the differences between group I and group I+P in the clinical and functional outcome and in the use of analgesics
Time frame: 6 months post-operative
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli