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
NCT ID: NCT06082271
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2021-05-28
2023-12-20
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Cortisone
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Hydrolyzed Collagen Peptides
The use is alternative to cortisone
Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Anti-inflammatory and regenerative effect, 5 mg/ml
Interventions
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Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Anti-inflammatory and regenerative effect, 5 mg/ml
Cortisone
DEPO-MEDROL 40 mg/ml + 1 cc di NAROPINA 0,75% 7,5 mg/ml
Eligibility Criteria
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Inclusion Criteria
* ability to provide informed consent
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Eleonora Olivotto
UNKNOWN
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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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.
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.
Goldring MB, Otero M. Inflammation in osteoarthritis. Curr Opin Rheumatol. 2011 Sep;23(5):471-8. doi: 10.1097/BOR.0b013e328349c2b1.
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.
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.
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.
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.
Patel K, Wallace R, Busconi BD. Radiology. Clin Sports Med. 2011 Apr;30(2):239-83. doi: 10.1016/j.csm.2010.12.004.
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.
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.
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.
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.
Other Identifiers
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FAI_DM
Identifier Type: -
Identifier Source: org_study_id
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