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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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06082271
Collaborator
Eleonora Olivotto (Other)
25
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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 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).

Condition or Disease Intervention/Treatment Phase
  • Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
  • Drug: Cortisone
 N/A

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, 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 samplingPatients 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
May 28, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 27, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cortisone (C)

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
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Experimental: Hydrolyzed Collagen Peptides

The use is alternative to cortisone

Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Anti-inflammatory and regenerative effect, 5 mg/ml

Outcome Measures

Primary Outcome Measures

  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. [Pre-operative; 1 and 6 months post-operative]

    Investigate the preoperative symptoms and hip function

  2. Visual Analogue Scale (VAS) [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) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Ortopedico Rizzoli Bologna Italy 40136

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli
  • Eleonora Olivotto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT06082271
Other Study ID Numbers:
  • FAI_DM
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis, Hip
Femoracetabular Impingement
Cortisone

Study Results

No Results Posted as of Oct 13, 2023