NCT07657871

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
59mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jun 2031

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

4.9 years

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

FAIMinced cartilage implantationmicrofracture

Outcome Measures

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

    One year

Study Arms (2)

MCI group

EXPERIMENTAL

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

Procedure: Minced cartilage implantation - MCI

Microfracture group

ACTIVE COMPARATOR

Microfracture surgery is a surgical technique for repairing joint cartilage

Procedure: Microfracture

Interventions

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.

MCI group
MicrofracturePROCEDURE

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

Microfracture group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique De La Sauvegarde

Lyon, 69009, France

Location

ICOSS

Strasbourg, 67100, France

Location

MeSH Terms

Conditions

Femoracetabular ImpingementFractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations