Comparison of Minced Cartilage Implantation Versus Microfracture for Acetabular Chondral Lesions Due to FAI (Femoro-acetabular Impingement)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minced cartilage implantation - MCI

    Procedure/Surgery

    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.

  • Microfracture

    Procedure/Surgery

    Microfracture surgery is a surgical technique that works by creating tiny fractures in the underlying bone. This stimulates the growth of new cartilage.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: MCI groupExperimental treatment 1 intervention
Group B: Microfracture groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

International Hip Outcome Tool-12 (iHOT-12)

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

Time frame
One year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: