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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicolas BONIN, MD
- Número de teléfono: + 33 4 72 20 00 00
- Correo electrónico: dr.bonin@lyon-ortho-clinic.com
Ubicaciones de estudio
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Lyon, Francia, 69009
- Clinique De La Sauvegarde
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Contacto:
- Nicolas BONIN, MD
- Número de teléfono: + 33 4 72 20 00 00
- Correo electrónico: dr.bonin@lyon-ortho-clinic.com
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Strasbourg, Francia, 67100
- ICOSS
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Contacto:
- Michel RAHME, MD
- Número de teléfono: +33 6 84 49 41 20
- Correo electrónico: dr.mrahme@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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International Hip Outcome Tool-12 (iHOT-12)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Heridas y Lesiones
- Procesos Patológicos
- Enfermedades Articulares
- Fracturas, Hueso
- Condiciones Patológicas, Signos y Síntomas
- Pinzamiento femoracetabular
- Fracturas, Estrés
- Procedimientos quirúrgicos, operativo
- Artroplastia
- Procedimientos ortopédicos
- Procedimientos de cirugía plástica
- Artroplastia, subcondral
Otros números de identificación del estudio
- 2026-A00200-51
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Pinzamiento Femoro-acetabular (FAI)
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Peking University Third HospitalTerminadoPinzamiento Femoro-acetabular (FAI)Porcelana