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Femoroacetabular ImpingementNCT06082271

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

A study testing Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys) and Cortisone in people with Femoroacetabular Impingement and Hip Arthroscopy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys) and Cortisone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteItaly
Study dates
28 May 2021to 20 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

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).

Read the 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.

Being tested
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys), Cortisone
Medical subject headings
Femoracetabular Impingement, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)Device

    Anti-inflammatory and regenerative effect, 5 mg/ml

  • CortisoneDrug

    DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml

Study groups in NCT06082271
Study groupRoleWhat they receive
Cortisone (C)Active comparatorTo improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.
Receives: Drug: Cortisone
Hydrolyzed Collagen PeptidesExperimentalThe use is alternative to cortisone
Receives: Device: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Investigate the preoperative symptoms and hip function

    Measured: Pre-operative; 1 and 6 months post-operative

  2. 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.

    Measured: Pre-operative; 1 and 6 months post-operative

  3. 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.

    Measured: Pre-operative; 1 and 6 months post-operative

Secondary outcomes (3)

  1. 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

    Measured: Pre-operative; 1 and 6 months post-operative

  2. 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

    Measured: Pre-operative; 1 and 6 months post-operative

  3. 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

    Measured: 6 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start28 May 2021
  3. Primary completion30 Nov 2023
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 sampling
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082271
Sponsor's protocol ID
FAI_DM
Status last verified
Jan 2024
First submitted
21 Sep 2023
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nepple JJ, Clohisy JC; ANCHOR Study Group Members. Evolution of Femoroacetabular Impingement Treatment: The ANCHOR Experience. Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):28-34.

    PubMed 28235110

  • Agricola R, Heijboer MP, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Waarsing JH. Cam impingement causes osteoarthritis of the hip: a nationwide prospective cohort study (CHECK). Ann Rheum Dis. 2013 Jun;72(6):918-23. doi: 10.1136/annrheumdis-2012-201643. Epub 2012 Jun 23.

    PubMed 22730371

  • Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.

    PubMed 21788902

  • Sellam J, Berenbaum F. The role of synovitis in pathophysiology and clinical symptoms of osteoarthritis. Nat Rev Rheumatol. 2010 Nov;6(11):625-35. doi: 10.1038/nrrheum.2010.159. Epub 2010 Oct 5.

    PubMed 20924410

  • Scanzello CR, Goldring SR. The role of synovitis in osteoarthritis pathogenesis. Bone. 2012 Aug;51(2):249-57. doi: 10.1016/j.bone.2012.02.012. Epub 2012 Feb 22.

    PubMed 22387238

  • Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.

    PubMed 23194896

  • Nepple JJ, Carlisle JC, Nunley RM, Clohisy JC. Clinical and radiographic predictors of intra-articular hip disease in arthroscopy. Am J Sports Med. 2011 Feb;39(2):296-303. doi: 10.1177/0363546510384787. Epub 2010 Nov 23.

    PubMed 21098820

  • Patel K, Wallace R, Busconi BD. Radiology. Clin Sports Med. 2011 Apr;30(2):239-83. doi: 10.1016/j.csm.2010.12.004.

    PubMed 21419955

  • Dolan MM, Heyworth BE, Bedi A, Duke G, Kelly BT. CT reveals a high incidence of osseous abnormalities in hips with labral tears. Clin Orthop Relat Res. 2011 Mar;469(3):831-8. doi: 10.1007/s11999-010-1539-6. Epub 2010 Oct 1.

    PubMed 20886325

  • Simpson J, Sadri H, Villar R. Hip arthroscopy technique and complications. Orthop Traumatol Surg Res. 2010 Dec;96(8 Suppl):S68-76. doi: 10.1016/j.otsr.2010.09.010. Epub 2010 Oct 30.

    PubMed 21036688

  • Volpi P, Zini R, Erschbaumer F, Beggio M, Busilacchi A, Carimati G. Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study. Int Orthop. 2021 Feb;45(2):375-380. doi: 10.1007/s00264-020-04616-8. Epub 2020 May 23.

    PubMed 32447428

  • Krych AJ, Griffith TB, Hudgens JL, Kuzma SA, Sierra RJ, Levy BA. Limited therapeutic benefits of intra-articular cortisone injection for patients with femoro-acetabular impingement and labral tear. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):750-5. doi: 10.1007/s00167-014-2862-3. Epub 2014 Feb 1.

    PubMed 24488223

Questions about this trial

What is this clinical trial studying?

A study testing Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys) and Cortisone in people with Femoroacetabular Impingement and Hip Arthroscopy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Pre-operative; 1 and 6 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06082271, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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