Comparison of Minced Cartilage Implantation Versus Microfracture for Acetabular Chondral Lesions Due to FAI (Femoro-acetabular Impingement) (CARTIFRAC)
A femoroacetabular impingement (FAI) is an abnormal contact between pelvis and the neck of femur. It occurs particularly when patient bends his hip and causes damage to the cartilage. In the long term, FAI can lead to the development of osteoarthritis (cartilage destruction) and may require a total hip replacement (THR).
Surgery to treat cartilage damage in the hip aims to maintain joint function and delay the onset of osteoarthritis. Microfracture remains the most commonly used treatment for cartilage lesions. It is a surgical technique for repairing articular cartilage that works by creating tiny fractures in the bone, which in turn stimulate the growth of new cartilage.
Cartilage autografting is a promising alternative to microfracture, offering good results in the knee joint. Cartilage autografting involves the use of autologous cartilage tissue (taken from patient body), which is harvested, ground up and reimplanted in a single surgical procedure to promote the growth of new cartilage and repair.
The published literature lacks large-scale studies comparing autologous cartilage transplantation with traditional joint-preserving surgeries, such as microfracture. This is the reason why this study is set up.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Patients with femoro-acetabular impingement (FAI) often develop acetabular chondral lesions, which can impair joint function and reduce quality of life. If left untreated, chondral lesions can progress to osteoarthritis and thus require total hip arthroplasty.
Joint preservation surgeries for the treatment of hip chondral lesions, aim to maintain joint function and delay the onset of osteoarthritis. Microfracture remains the most commonly used treatment for chondral lesions.
Although microfracture is the reference surgical treatment for acetabular chondral lesions, several clinical studies and systematic reviews have reported higher rates of conversion to THA and lower patient-reported outcomes for microfracture compared to other techniques. Furthermore, microfracture can weaken subchondral bone and increase the formation of subchondral cysts, which may explain its inferior outcomes.
Minced cartilage implantation (MCI) has emerged as a promising alternative to microfracture, providing good outcomes in the knee joint. MCI involves the use of autologous cartilage tissue, which is harvested, minced, and re-implanted in a one-stage surgery to promote chondrogenesis and repair. Only one published study has reported on outcomes of MCI in the hip joint, showing good results for 11 male patients with FAI at 2 years follow-up. Therefore, the published literature lacks large-cohort studies that compare MCI to traditional joint preservation surgeries, such as microfracture.
This is the reason why this Clinical Study is set up. The hypothesis is that MCI will provide better short- to mid-term outcomes than microfracture in patients with acetabular chondral lesions due to FAI.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nicolas BONIN, MD
- Telefoonnummer: + 33 4 72 20 00 00
- E-mail: dr.bonin@lyon-ortho-clinic.com
Studie Locaties
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Lyon, Frankrijk, 69009
- Clinique de la Sauvegarde
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Contact:
- Nicolas BONIN, MD
- Telefoonnummer: + 33 4 72 20 00 00
- E-mail: dr.bonin@lyon-ortho-clinic.com
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Strasbourg, Frankrijk, 67100
- ICOSS
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Contact:
- Michel RAHME, MD
- Telefoonnummer: +33 6 84 49 41 20
- E-mail: dr.mrahme@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patient, male or female, aged 18-50 years old;
- Patient with an acetabular chondral lesion due to FAI, characterised as Beck class 4 or 5, measuring 1-6 cm2;
- Patient with Tönnis grade 0-2;
- Patient who signed the informed consent form and is willing to comply with the protocol requirements based on the investigator's judgment;
- Patient affiliated with a social security scheme;
- Patient able to answer questionnaires and to communicate freely in French
Exclusion Criteria:
- Patient with prior ipsilateral hip surgery;
- Patient with borderline or frank hip dysplasia (lateral centre edge angle <25º);
- Patient with hyperlaxity (Beighton score >7);
- Patient with any concomitant disease or disorder which, in the opinion of the investigator, may put the patient at risk or may influence the result of the study;
- Patient that is pregnant or breastfeeding;
- Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;
- Patient who cannot comply with the protocol requirements based on the investigator's judgment
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: MCI group
MCI involves the use of autologous cartilage tissue, which is harvested, minced, and re-implanted in a one-stage surgery to promote chondrogenesis and repair
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Autologous minced cartilage will be harvested from the defect site and cam deformity area using a non-aggressive shaver blade .
The cartilage will then be collected and augmented with platelet-rich plasma from the patient's blood.
The platelet-rich plasma will be 100% autologous.
Cautious debridement of the chondral lesion up to the stable chondral margins will be performed, followed by removal of the calcified subchondral bone layer, then the minced cartilage will be implanted on the acetabular chondral lesion using an application cannula.
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Actieve vergelijker: Microfracture group
Microfracture surgery is a surgical technique for repairing joint cartilage
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Microfracture surgery is a surgical technique that works by creating tiny fractures in the underlying bone.
This stimulates the growth of new cartilage.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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International Hip Outcome Tool-12 (iHOT-12)
Tijdsspanne: One year
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The iHOT-12 is a validated self-administered questionnaire that measures health-related quality of life and changes after hip preserving treatments, in young active patients with hip disorders [13].
The questionnaire comprises 12 items, covering four domains: (i) symptoms and functional limitations, (ii) sport and recreational activities, (iii) job-related concerns, and [14] social, emotional, and lifestyle concerns.
Each item is scored using a visual analog scale (VAS) from 0 to 100, with a score of 100 being the best function and least amount of symptoms.
The final iHOT score is calculated as the overall mean of all 12 items, ranging from 0 to 100
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One year
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Musculoskeletale aandoeningen
- Wonden en verwondingen
- Pathologische processen
- Gewrichtsziekten
- Breuken, bot
- Pathologische aandoeningen, tekenen en symptomen
- Femoracetabulaire impingement
- Breuken, spanning
- Chirurgische procedures, operatief
- Artroplastiek
- Orthopedische procedures
- Procedures voor plastische chirurgie
- Arthroplastiek, subchondraal
Andere studie-ID-nummers
- 2026-A00200-51
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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