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

NCT06082271 | Completed

• 1 other identifier: FAI_DM
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Femoroacetabular Impingement; Hip Arthroscopy; Hip Osteoarthritis; Hydrolyzed Collagen Peptides

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Pre-operative; 1 and 6 months post-operative

Secondary Outcomes (3)

• Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative outcomes

  Pre-operative; 1 and 6 months post-operative

• Correlation between biomarkers in the pre-operative synovial fluid/urine and post-operative pain

  Pre-operative; 1 and 6 months post-operative

• Differences between the two study groups

  6 months post-operative

Study Arms (2)

Cortisone (C)

ACTIVE COMPARATOR

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

Hydrolyzed Collagen Peptides

EXPERIMENTAL

The use is alternative to cortisone

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

Interventions

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

Anti-inflammatory and regenerative effect, 5 mg/ml

Hydrolyzed Collagen Peptides

Cortisone DRUG

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

Cortisone (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Eleonora Olivotto: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (12)

• 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.

  PMID: 28235110 BACKGROUND

• 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.

  PMID: 22730371 BACKGROUND

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

  PMID: 21788902 BACKGROUND

• 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.

  PMID: 20924410 BACKGROUND

• 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.

  PMID: 22387238 BACKGROUND

• 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.

  PMID: 23194896 BACKGROUND

• 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.

  PMID: 21098820 BACKGROUND

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

  PMID: 21419955 BACKGROUND

• 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.

  PMID: 20886325 BACKGROUND

• 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.

  PMID: 21036688 BACKGROUND

• 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.

  PMID: 32447428 BACKGROUND

• 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.

  PMID: 24488223 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement; Osteoarthritis, Hip

Interventions

Cortisone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 13, 2023
• Study Start: May 28, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 20, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)