Focal Cartilage Lesions of the KneeCART-MCI KneeNCT07641868
Management of Focal Cartilage Lesions of the Knee: The Benefits of an Autograft Procedure
A study testing Management of focal cartilage lesions of the knee: micro-fracture and Minced Cartilage Implantation (MCI) in people with Focal Cartilage Lesions of the Knee, run by Louis Pasteur Santé Lorraine at 1 site in France.
Trial summary
Cartilage is a tissue whose primary function is to transmit and distribute loads when joints are under stress. It acts as a buffer between bones at the joints. Over time, or due to diseases and/or trauma, this surface can disappear, leading to pain and limited movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Cartilage Lesions of the Knee
- What is being tested?
- Management of focal cartilage lesions of the knee: micro-fracture and Minced Cartilage Implantation (MCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged over 18 years.
- Patient who has signed an informed consent form.
- Patient with focal cartilage lesions of the knee, classified as grade 4 on MRI according to the International Cartilage Repair Society classification (exposure of subchondral bone), regardless of size, and for which surgery is indicated.
- Be affiliated with or a beneficiary of a social security scheme.
Who cannot join
- Revision knee surgery
- Body Mass Index (BMI) > 27 kg/m²
- Joint space narrowing on standard radiographic examination
- Refusal of consent
- Patient unable to read, write, or understand French
- Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP)
Show all 11Show fewer
- Adult patient under guardianship, curatorship, or legal protection
- Patient unable to give Personally, their consent according to Article L.1121-8 of the French Public Health Code (CSP) or an adult protected by law
- Pregnant or breastfeeding woman according to Article L1121-5 of the French Public Health Code (CSP)
- Patient who has already participated in a study within the last 12 months
- Patient already enrolled in another ongoing clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique Louis Pasteur - Louis Pasteur Santé Lorraine
Essey-lès-Nancy, Grand Est, 54270
Frank WEIN, +33383188340, frankwein@yahoo.fr
Frank WEIN
About this study
Cartilage is a tissue whose primary function is to transmit and distribute loads when joints are under stress. It acts as a buffer between bones at the joints. Over time, or due to diseases and/or trauma, this surface can disappear, leading to pain and limited movement. Cartilage lesions are particularly difficult to treat because cartilage has a limited capacity for regeneration.
When cartilage lesions are characterized by a localized defect, several surgical techniques are available to restore cartilage tissue to the affected area.
Read more
The most frequently used surgical technique is bone marrow stimulation, also known as microfracture. The cartilage lesion is debrided, the subchondral bone exposed, and then a punch is used to perforate the subchondral bone, allowing a clot to form within the defect. This clot will proliferate and differentiate into scar tissue. However, this cellular differentiation results in fibrocartilaginous tissue rather than hyaline cartilage, sometimes with disappointing clinical outcomes.
Other techniques for cartilage restoration exist and are used routinely, including more biological techniques such as Minced Cartilage Implantation (MCI). Autologous cartilage is first harvested from around the defect, chopped into very small fragments, and then reimplanted. Cartilage fragmentation activates cell proliferation and migration, followed by the synthesis of an extracellular, cartilaginous matrix. The effectiveness of this fragmentation is increased with fine fragments (<0.3 mm). Cell proliferation and activity appear to be stimulated by the systematic addition of PRP (Platelet-Rich Plasma) during the MCI procedure.
The expected benefit of an MCI approach lies in clinical improvement and better cartilage regeneration (observed on imaging) compared to microfracture.
The objective is to conduct a controlled, randomized, blinded study (blinded to both the patient and the MRI assessor of the bone graft) to determine the benefit of an MCI approach versus microfracture.
Read the detailed description
Objective : Primary objective: To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery.
Secondary objectives:
- To demonstrate the clinical benefit (based on functional scores and the need for re-intervention) of the MCI approach at different follow-up visits.
- To describe all post-operative complications.
- To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery in patients with lesions larger than 2 cm².
Outcome Measures :
Primary endpoint: Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
Secondary endpoints:
- Functional scores at baseline, at 3, 9, and 24 months:
- Visual Analog Scale (VAS)
- Self Knee Value (SKV)
- Knee Injury and Osteoarthritis Outcome Score (KOOS score)
- and Tegner-Lysholm activity score
- Postoperative complications from all causes at each visit
- Need for reoperation at 3, 9, and 24 months post-surgery.
Single-center, controlled, randomized, blinded (patient and MRI assessor blinded), two parallel arms with a 1:1 ratio:
- Arm 1: Microfractures
- Arm 2: Minced Cartilage Implantation (MCI)
Randomization will be stratified by:
- Age (< 30 years vs ≥ 30 years)
- Lesion size (< 2 cm² vs ≥ 2 cm²)
Inclusion criteria:
- Male or female, aged over 18 years.
- Patient who has signed an informed consent form.
- Patient with focal cartilage lesions of the knee, classified as grade 4 on MRI according to the International Cartilage Repair Society classification (exposure of subchondral bone), regardless of their size, and for which surgery is indicated.
- Be affiliated with a social security scheme or a beneficiary of such a scheme
Exclusion criteria:
- Revision knee surgery
- Body Mass Index (BMI) > 27 kg/m2
- Joint space narrowing on standard radiographic examination
- Refusal of consent
- Patient unable to read, write, or understand French
- Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP)
- Adult patient under guardianship, curatorship, or legal protection
- Patient unable to personally give consent according to Article L.1121-8 of the French Public Health Code (CSP) or an adult protected by law
- Pregnant or breastfeeding woman according to Article L1121-5 of the French Public Health Code (CSP)
- Patient who has already participated in a study within the last 12 months
- Patient already enrolled in another ongoing clinical trial
For patients randomized to the Microfracture arm, the procedure will be as follows: under arthroscopy, the lesion is prepared by debriding it.
Using a specific punch, perforations are made perpendicular to the exposed bone surface.
The technical principles are as follows:
- Perforation depth: approximately 3 to 4 mm, allowing access to the bone marrow,
- Regular spacing between perforations: 3 to 4 mm,
- Preservation of the integrity of the interfracture bone bridges to avoid excessive weakening of the bone endplate.
For patients randomized to the MCI arm, the procedure will be as follows: during surgery, after visualization and debridement of the lesion, cartilage tissue is harvested from a low-weight, and therefore low-stress, area. This cartilage tissue is then fragmented and mixed with PRP (Platelet-Rich Plasma), collected from the patient's blood. Platelets are unique in that they have a high concentration of universal growth factors, enabling them to heal virtually all organic tissues. Adding PRP to the fragmented cartilage tissue promotes cartilage regeneration and the incorporation of the graft into the lesion. To ensure the graft adheres to the bone tissue, it is secured biologically (with thrombin). Post-operative recovery is typical, with a gradual return to walking and other activities.
The participant participation scheme is as follows:
- Baseline: clinical examination + MRI + self-administered questionnaires
- Inclusion and randomization after eligibility verification
- Day 0: surgical intervention according to randomization (MCI vs. microfractures)
- Discharge from hospital: clinical examination + complications
- Post-surgery visit (M3 +/- 1 month): clinical examination + self-administered questionnaires + complications + need for re-surgery
- Post-surgery visit (M9 +/- 1 month): clinical examination + self-administered questionnaires + complications + need for re-surgery
- Post-surgery visit (M24 +/- 1 month): clinical examination + MRI with MOCART score calculation + self-administered questionnaires + complications + need for re-surgery
To demonstrate a difference in filling rate of 30 points (90% in the MCI arm versus 60% in the Microfractures arm) with a standard deviation of 40%, a type I error rate of 5%, and a power of 80%, 28 evaluable subjects per arm are required. To account for unanalyzable data and the potential for patients lost to follow-up, we propose including a total of 80 subjects (40 per arm) in this study.
- Conditions
- Focal Cartilage Lesions of the Knee
- Being tested
- Management of focal cartilage lesions of the knee: micro-fracture, Minced Cartilage Implantation (MCI)
- Keywords
- Minced Cartilage Implantation, Micro-fracture, Knee
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of focal cartilage lesions of the knee: micro-fractureProcedure or surgery
Also called Management of focal cartilage lesions of the knee: Minced Cartilage Implantation (MCI)
Patients will be randomized in the study to:
- Either the Microfracture arm
- Or the Minced Cartilage Implantation (MCI) arm
Minced Cartilage Implantation (MCI)Procedure or surgery
Patients will be randomized in the study to:
- Either the Microfracture arm
- Or the Minced Cartilage Implantation (MCI) arm
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Microfractures | Active comparator | For patients randomized to the Microfracture arm, the procedure will be as follows: under arthroscopy, the lesion is prepared by debriding it.
Using a specific punch, perforations are made perpendicular to the exposed bone surface.
The technical principles are as follows:
* Perforation depth: approximately 3 to 4 mm, allowing access to the bone marrow,
* Regular spacing between perforations: 3 to 4 mm,
* Preservation of the integrity of the interfracture bone bridges to avoid excessive weakening of the bone endplate. Receives: Procedure: Management of focal cartilage lesions of the knee: micro-fracture |
| Arm 2: Minced Cartilage Implantation (MCI) | Experimental | For patients randomized to the MCI arm, the procedure will be as follows: during surgery, after visualization and debridement of the lesion, cartilage tissue is harvested from a low-weight, and therefore low-stress, area. This cartilage tissue is then fragmented and mixed with PRP (Platelet-Rich Plasma), collected from the patient's blood. Platelets are unique in their high concentration of universal growth factors, and therefore have the ability to promote the healing of almost all organic tissues. This addition of PRP to the fragmented cartilage tissue will thus promote cartilage regeneration and the incorporation of the graft within the lesion. To ensure the graft adheres to the bone tissue, the entire structure is secured biologically (thrombin). Postoperative recovery is standard, with a gradual resumption of walking and activities. Receives: Procedure: Minced Cartilage Implantation (MCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone grafting
Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
Measured: at 24 months after surgery
Secondary outcomes (6)
Functional scores
Scores fonctionnels :
- Visual Analogic Scale (VAS)
Measured: Baseline, at 3 months, 9 months, 24 months after surgery
Functional scores
Scores fonctionnels :
- Self Knee Value (SKV)
Measured: Baseline 3 months, 9 months, 24 months after surgery
Functional scores
Functional scores : Knee Injury and Osteoarthritis Outcome Score (KOOS score)
Measured: Baseline 3 months, 9 months, 24 months after surgery
Functional scores
Tegner Lysholm activity score
Measured: Baseline 3 months, 9 months and 24 months after surgery
Post-operative complications
Post-operative complications of all causes
Measured: Immediately after surgery until max. 96 hours after surgery (corresponding to hospital discharge), 3 months, 9 months, 24 months after surgery
Re-intervention required
Re-intervention required
Measured: at 3, 9, and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Focal Cartilage Lesions of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, controlled, randomized, blinded (patient and MRI assessor blinded), two-arm parallel study with a 1:1 ratio: * Arm 1: Microfractures * Arm 2: Minced Cartilage Implantation (MCI)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Pasteur Santé Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank WEIN, Principal investigator, Louis Pasteur Santé Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641868
- Sponsor's protocol ID
- 2026-A00152-49
- Acronym
- CART-MCI Knee
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wylie JD, Hartley MK, Kapron AL, Aoki SK, Maak TG. Failures and Reoperations After Matrix-Assisted Cartilage Repair of the Knee: A Systematic Review. Arthroscopy. 2016 Feb;32(2):386-92. doi: 10.1016/j.arthro.2015.07.025. Epub 2015 Sep 28.
PubMed 26422710Tsuyuguchi Y, Nakasa T, Ishikawa M, Miyaki S, Matsushita R, Kanemitsu M, Adachi N. The Benefit of Minced Cartilage Over Isolated Chondrocytes in Atelocollagen Gel on Chondrocyte Proliferation and Migration. Cartilage. 2021 Jan;12(1):93-101. doi: 10.1177/1947603518805205. Epub 2018 Oct 12.
PubMed 30311776Triana J, Hughes AJ, Rao N, Li ZI, Moore MR, Garra S, Strauss EJ, Jazrawi LM, Campbell KA, Gonzalez-Lomas G. Comparable Clinical and Functional Outcomes Between Osteochondral Allograft Transplantation and Autologous Chondrocyte Implantation for Articular Cartilage Lesions in the Patellofemoral Joint at a Mean Follow-Up of 5 Years. Arthroscopy. 2025 Mar;41(3):745-758. doi: 10.1016/j.arthro.2024.05.018. Epub 2024 Jun 4.
PubMed 38844011Smith L, Jakubiec A, Biant L, Tawy G. The biomechanical and functional outcomes of autologous chondrocyte implantation for articular cartilage defects of the knee: A systematic review. Knee. 2023 Oct;44:31-42. doi: 10.1016/j.knee.2023.07.004. Epub 2023 Jul 27.
PubMed 37516029Schreiner MM, Raudner M, Marlovits S, Bohndorf K, Weber M, Zalaudek M, Rohrich S, Szomolanyi P, Filardo G, Windhager R, Trattnig S. The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score and Atlas. Cartilage. 2021 Dec;13(1_suppl):571S-587S. doi: 10.1177/1947603519865308. Epub 2019 Aug 17.
PubMed 31422674Schneider S, Ossendorff R, Holz J, Salzmann GM. Arthroscopic Minced Cartilage Implantation (MCI): A Technical Note. Arthrosc Tech. 2020 Dec 19;10(1):e97-e101. doi: 10.1016/j.eats.2020.09.015. eCollection 2021 Jan.
PubMed 33532215Saris DB, Vanlauwe J, Victor J, Almqvist KF, Verdonk R, Bellemans J, Luyten FP; TIG/ACT/01/2000&EXT Study Group. Treatment of symptomatic cartilage defects of the knee: characterized chondrocyte implantation results in better clinical outcome at 36 months in a randomized trial compared to microfracture. Am J Sports Med. 2009 Nov;37 Suppl 1:10S-19S. doi: 10.1177/0363546509350694. Epub 2009 Oct 21.
PubMed 19846694Salzmann GM, Sah B, Sudkamp NP, Niemeyer P. Reoperative characteristics after microfracture of knee cartilage lesions in 454 patients. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):365-71. doi: 10.1007/s00167-012-1973-y. Epub 2012 Apr 8.
PubMed 22484416Salzmann GM, Ossendorff R, Gilat R, Cole BJ. Autologous Minced Cartilage Implantation for Treatment of Chondral and Osteochondral Lesions in the Knee Joint: An Overview. Cartilage. 2021 Dec;13(1_suppl):1124S-1136S. doi: 10.1177/1947603520942952. Epub 2020 Jul 25.
PubMed 32715735Runer A, Ossendorff R, Ottl F, Stadelmann VA, Schneider S, Preiss S, Salzmann GM, Hax J. Autologous minced cartilage repair for chondral and osteochondral lesions of the knee joint demonstrates good postoperative outcomes and low reoperation rates at minimum five-year follow-up. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4977-4987. doi: 10.1007/s00167-023-07546-1. Epub 2023 Aug 27.
PubMed 37634136Rothdiener M, Uynuk-Ool T, Sudkamp N, Aurich M, Grodzinsky AJ, Kurz B, Rolauffs B. Human osteoarthritic chondrons outnumber patient- and joint-matched chondrocytes in hydrogel culture-Future application in autologous cell-based OA cartilage repair? J Tissue Eng Regen Med. 2018 Feb;12(2):e1206-e1220. doi: 10.1002/term.2516. Epub 2017 Nov 8.
PubMed 28714570Moser LB, Fickert S, Pitzek S, Bauer C, Neubauer M, Dammerer D, Zantop T, Landgraeber S, Nehrer S. Minced cartilage for focal cartilage defects-A comprehensive systematic review of surgical techniques in clinical studies, animal studies and basic research studies. Knee Surg Sports Traumatol Arthrosc. 2025 Oct;33(10):3571-3591. doi: 10.1002/ksa.12608. Epub 2025 Mar 7.
PubMed 40053917Milano G, Deriu L, Sanna Passino E, Masala G, Manunta A, Postacchini R, Saccomanno MF, Fabbriciani C. Repeated platelet concentrate injections enhance reparative response of microfractures in the treatment of chondral defects of the knee: an experimental study in an animal model. Arthroscopy. 2012 May;28(5):688-701. doi: 10.1016/j.arthro.2011.09.016. Epub 2012 Jan 25.
PubMed 22277762Migliorini F, Baroncini A, Bell A, Weber C, Hildebrand F, Maffulli N. Surgical strategies for chondral defects of the patellofemoral joint: a systematic review. J Orthop Surg Res. 2022 Dec 5;17(1):524. doi: 10.1186/s13018-022-03419-4.
PubMed 36471319Meyerkort D, Ebert JR, Ackland TR, Robertson WB, Fallon M, Zheng MH, Wood DJ. Matrix-induced autologous chondrocyte implantation (MACI) for chondral defects in the patellofemoral joint. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2522-30. doi: 10.1007/s00167-014-3046-x. Epub 2014 May 11.
PubMed 24817164
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Focal Cartilage Lesions of the Knee: The Benefits of an Autograft Procedure
- ClinicalTrials.gov ID
- NCT07641868
- Acronym / sponsor ID
- CART-MCI Knee / 2026-A00152-49
- Conditions
- Focal Cartilage Lesions of the Knee
- Keywords
- Minced Cartilage Implantation, Micro-fracture, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Louis Pasteur Santé LorraineUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cartilage is a tissue whose primary function is to transmit and distribute loads when joints are under stress. It acts as a buffer between bones at the joints. Over time, or due to diseases and/or trauma, this surface can disappear, leading to pain and limited movement. Cartilage lesions are particularly difficult to treat because cartilage has a limited capacity for regeneration.
When cartilage lesions are characterized by a localized defect, several surgical techniques are available to restore cartilage tissue to the affected area.
The most frequently used surgical technique is bone marrow stimulation, also known as microfracture. The cartilage lesion is debrided, the subchondral bone exposed, and then a punch is used to perforate the subchondral bone, allowing a clot to form within the defect. This clot will proliferate and differentiate into scar tissue. However, this cellular differentiation results in fibrocartilaginous tissue rather than hyaline cartilage, sometimes with disappointing clinical outcomes.
Other techniques for cartilage restoration exist and are used routinely, including more biological techniques such as Minced Cartilage Implantation (MCI). Autologous cartilage is first harvested from around the defect, chopped into very small fragments, and then reimplanted. Cartilage fragmentation activates cell proliferation and migration, followed by the synthesis of an extracellular, cartilaginous matrix. The effectiveness of this fragmentation is increased with fine fragments (<0.3 mm). Cell proliferation and activity appear to be stimulated by the systematic addition of PRP (Platelet-Rich Plasma) during the MCI procedure.
The expected benefit of an MCI approach lies in clinical improvement and better cartilage regeneration (observed on imaging) compared to microfracture.
The objective is to conduct a controlled, randomized, blinded study (blinded to both the patient and the MRI assessor of the bone graft) to determine the benefit of an MCI approach versus microfracture.
Detailed description
Objective : Primary objective: To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery.
Secondary objectives:
- To demonstrate the clinical benefit (based on functional scores and the need for re-intervention) of the MCI approach at different follow-up visits.
- To describe all post-operative complications.
- To demonstrate the benefit of the MCI approach in terms of lesion filling at 24 months post-surgery in patients with lesions larger than 2 cm².
Outcome Measures :
Primary endpoint: Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
Secondary endpoints:
- Functional scores at baseline, at 3, 9, and 24 months:
- Visual Analog Scale (VAS)
- Self Knee Value (SKV)
- Knee Injury and Osteoarthritis Outcome Score (KOOS score)
- and Tegner-Lysholm activity score
- Postoperative complications from all causes at each visit
- Need for reoperation at 3, 9, and 24 months post-surgery.
Single-center, controlled, randomized, blinded (patient and MRI assessor blinded), two parallel arms with a 1:1 ratio:
- Arm 1: Microfractures
- Arm 2: Minced Cartilage Implantation (MCI)
Randomization will be stratified by:
- Age (< 30 years vs ≥ 30 years)
- Lesion size (< 2 cm² vs ≥ 2 cm²)
Inclusion criteria:
- Male or female, aged over 18 years.
- Patient who has signed an informed consent form.
- Patient with focal cartilage lesions of the knee, classified as grade 4 on MRI according to the International Cartilage Repair Society classification (exposure of subchondral bone), regardless of their size, and for which surgery is indicated.
- Be affiliated with a social security scheme or a beneficiary of such a scheme
Exclusion criteria:
- Revision knee surgery
- Body Mass Index (BMI) > 27 kg/m2
- Joint space narrowing on standard radiographic examination
- Refusal of consent
- Patient unable to read, write, or understand French
- Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP)
- Adult patient under guardianship, curatorship, or legal protection
- Patient unable to personally give consent according to Article L.1121-8 of the French Public Health Code (CSP) or an adult protected by law
- Pregnant or breastfeeding woman according to Article L1121-5 of the French Public Health Code (CSP)
- Patient who has already participated in a study within the last 12 months
- Patient already enrolled in another ongoing clinical trial
For patients randomized to the Microfracture arm, the procedure will be as follows: under arthroscopy, the lesion is prepared by debriding it.
Using a specific punch, perforations are made perpendicular to the exposed bone surface.
The technical principles are as follows:
- Perforation depth: approximately 3 to 4 mm, allowing access to the bone marrow,
- Regular spacing between perforations: 3 to 4 mm,
- Preservation of the integrity of the interfracture bone bridges to avoid excessive weakening of the bone endplate.
For patients randomized to the MCI arm, the procedure will be as follows: during surgery, after visualization and debridement of the lesion, cartilage tissue is harvested from a low-weight, and therefore low-stress, area. This cartilage tissue is then fragmented and mixed with PRP (Platelet-Rich Plasma), collected from the patient's blood. Platelets are unique in that they have a high concentration of universal growth factors, enabling them to heal virtually all organic tissues. Adding PRP to the fragmented cartilage tissue promotes cartilage regeneration and the incorporation of the graft into the lesion. To ensure the graft adheres to the bone tissue, it is secured biologically (with thrombin). Post-operative recovery is typical, with a gradual return to walking and other activities.
The participant participation scheme is as follows:
- Baseline: clinical examination + MRI + self-administered questionnaires
- Inclusion and randomization after eligibility verification
- Day 0: surgical intervention according to randomization (MCI vs. microfractures)
- Discharge from hospital: clinical examination + complications
- Post-surgery visit (M3 +/- 1 month): clinical examination + self-administered questionnaires + complications + need for re-surgery
- Post-surgery visit (M9 +/- 1 month): clinical examination + self-administered questionnaires + complications + need for re-surgery
- Post-surgery visit (M24 +/- 1 month): clinical examination + MRI with MOCART score calculation + self-administered questionnaires + complications + need for re-surgery
To demonstrate a difference in filling rate of 30 points (90% in the MCI arm versus 60% in the Microfractures arm) with a standard deviation of 40%, a type I error rate of 5%, and a power of 80%, 28 evaluable subjects per arm are required. To account for unanalyzable data and the potential for patients lost to follow-up, we propose including a total of 80 subjects (40 per arm) in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, controlled, randomized, blinded (patient and MRI assessor blinded), two-arm parallel study with a 1:1 ratio: * Arm 1: Microfractures * Arm 2: Minced Cartilage Implantation (MCI)
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Microfractures | Active comparator | Procedure: Management of focal cartilage lesions of the knee: micro-fractureFor patients randomized to the Microfracture arm, the procedure will be as follows: under arthroscopy, the lesion is prepared by debriding it. Using a specific punch, perforations are made perpendicular to the exposed bone surface. The technical principles are as follows: * Perforation depth: approximately 3 to 4 mm, allowing access to the bone marrow, * Regular spacing between perforations: 3 to 4 mm, * Preservation of the integrity of the interfracture bone bridges to avoid excessive weakening of the bone endplate. |
| Arm 2: Minced Cartilage Implantation (MCI) | Experimental | Procedure: Minced Cartilage Implantation (MCI)For patients randomized to the MCI arm, the procedure will be as follows: during surgery, after visualization and debridement of the lesion, cartilage tissue is harvested from a low-weight, and therefore low-stress, area. This cartilage tissue is then fragmented and mixed with PRP (Platelet-Rich Plasma), collected from the patient's blood. Platelets are unique in their high concentration of universal growth factors, and therefore have the ability to promote the healing of almost all organic tissues. This addition of PRP to the fragmented cartilage tissue will thus promote cartilage regeneration and the incorporation of the graft within the lesion. To ensure the graft adheres to the bone tissue, the entire structure is secured biologically (thrombin). Postoperative recovery is standard, with a gradual resumption of walking and activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged over 18 years.
- Patient who has signed an informed consent form.
- Patient with focal cartilage lesions of the knee, classified as grade 4 on MRI according to the International Cartilage Repair Society classification (exposure of subchondral bone), regardless of size, and for which surgery is indicated.
- Be affiliated with or a beneficiary of a social security scheme.
Key exclusion criteria (11 listed)
- Revision knee surgery
- Body Mass Index (BMI) > 27 kg/m²
- Joint space narrowing on standard radiographic examination
- Refusal of consent
- Patient unable to read, write, or understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management of focal cartilage lesions of the knee: micro-fractureAlso: Management of focal cartilage lesions of the knee: Minced Cartilage Implantation (MCI)Patients will be randomized in the study to: * Either the Microfracture arm * Or the Minced Cartilage Implantation (MCI) arm | Procedure or surgery | Arm 1: Microfractures |
| Minced Cartilage Implantation (MCI)Patients will be randomized in the study to: * Either the Microfracture arm * Or the Minced Cartilage Implantation (MCI) arm | Procedure or surgery | Arm 2: Minced Cartilage Implantation (MCI) |
Primary outcome
Bone grafting
Time frame: at 24 months after surgery
Bone grafting will be measured by magnetic resonance imaging at 24 months using the MOCART score (Magnetic Resonance Observation of Cartilage Repair Tissue 2.0 Knee Score), which assesses the rate and quality of grafting. The evaluator will be blinded to the randomization arm.
6 secondary outcomes
Functional scores
Time frame: Baseline, at 3 months, 9 months, 24 months after surgery
Functional scores
Time frame: Baseline 3 months, 9 months, 24 months after surgery
Functional scores
Time frame: Baseline 3 months, 9 months, 24 months after surgery
Functional scores
Time frame: Baseline 3 months, 9 months and 24 months after surgery
Post-operative complications
Time frame: Immediately after surgery until max. 96 hours after surgery (corresponding to hospital discharge), 3 months, 9 months, 24 months after surgery
Re-intervention required
Time frame: at 3, 9, and 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 26422710Wylie JD, Hartley MK, Kapron AL, Aoki SK, Maak TG. Failures and Reoperations After Matrix-Assisted Cartilage Repair of the Knee: A Systematic Review. Arthroscopy. 2016 Feb;32(2):386-92. doi: 10.1016/j.arthro.2015.07.025. Epub 2015 Sep 28.
- Background: PubMed 30311776Tsuyuguchi Y, Nakasa T, Ishikawa M, Miyaki S, Matsushita R, Kanemitsu M, Adachi N. The Benefit of Minced Cartilage Over Isolated Chondrocytes in Atelocollagen Gel on Chondrocyte Proliferation and Migration. Cartilage. 2021 Jan;12(1):93-101. doi: 10.1177/1947603518805205. Epub 2018 Oct 12.
- Background: PubMed 38844011Triana J, Hughes AJ, Rao N, Li ZI, Moore MR, Garra S, Strauss EJ, Jazrawi LM, Campbell KA, Gonzalez-Lomas G. Comparable Clinical and Functional Outcomes Between Osteochondral Allograft Transplantation and Autologous Chondrocyte Implantation for Articular Cartilage Lesions in the Patellofemoral Joint at a Mean Follow-Up of 5 Years. Arthroscopy. 2025 Mar;41(3):745-758. doi: 10.1016/j.arthro.2024.05.018. Epub 2024 Jun 4.
- Background: PubMed 37516029Smith L, Jakubiec A, Biant L, Tawy G. The biomechanical and functional outcomes of autologous chondrocyte implantation for articular cartilage defects of the knee: A systematic review. Knee. 2023 Oct;44:31-42. doi: 10.1016/j.knee.2023.07.004. Epub 2023 Jul 27.
- Background: PubMed 31422674Schreiner MM, Raudner M, Marlovits S, Bohndorf K, Weber M, Zalaudek M, Rohrich S, Szomolanyi P, Filardo G, Windhager R, Trattnig S. The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score and Atlas. Cartilage. 2021 Dec;13(1_suppl):571S-587S. doi: 10.1177/1947603519865308. Epub 2019 Aug 17.
- Background: PubMed 33532215Schneider S, Ossendorff R, Holz J, Salzmann GM. Arthroscopic Minced Cartilage Implantation (MCI): A Technical Note. Arthrosc Tech. 2020 Dec 19;10(1):e97-e101. doi: 10.1016/j.eats.2020.09.015. eCollection 2021 Jan.
- Background: PubMed 19846694Saris DB, Vanlauwe J, Victor J, Almqvist KF, Verdonk R, Bellemans J, Luyten FP; TIG/ACT/01/2000&EXT Study Group. Treatment of symptomatic cartilage defects of the knee: characterized chondrocyte implantation results in better clinical outcome at 36 months in a randomized trial compared to microfracture. Am J Sports Med. 2009 Nov;37 Suppl 1:10S-19S. doi: 10.1177/0363546509350694. Epub 2009 Oct 21.
- Background: PubMed 22484416Salzmann GM, Sah B, Sudkamp NP, Niemeyer P. Reoperative characteristics after microfracture of knee cartilage lesions in 454 patients. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):365-71. doi: 10.1007/s00167-012-1973-y. Epub 2012 Apr 8.
- Background: PubMed 32715735Salzmann GM, Ossendorff R, Gilat R, Cole BJ. Autologous Minced Cartilage Implantation for Treatment of Chondral and Osteochondral Lesions in the Knee Joint: An Overview. Cartilage. 2021 Dec;13(1_suppl):1124S-1136S. doi: 10.1177/1947603520942952. Epub 2020 Jul 25.
- Background: PubMed 37634136Runer A, Ossendorff R, Ottl F, Stadelmann VA, Schneider S, Preiss S, Salzmann GM, Hax J. Autologous minced cartilage repair for chondral and osteochondral lesions of the knee joint demonstrates good postoperative outcomes and low reoperation rates at minimum five-year follow-up. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4977-4987. doi: 10.1007/s00167-023-07546-1. Epub 2023 Aug 27.
- Background: PubMed 28714570Rothdiener M, Uynuk-Ool T, Sudkamp N, Aurich M, Grodzinsky AJ, Kurz B, Rolauffs B. Human osteoarthritic chondrons outnumber patient- and joint-matched chondrocytes in hydrogel culture-Future application in autologous cell-based OA cartilage repair? J Tissue Eng Regen Med. 2018 Feb;12(2):e1206-e1220. doi: 10.1002/term.2516. Epub 2017 Nov 8.
- Background: PubMed 40053917Moser LB, Fickert S, Pitzek S, Bauer C, Neubauer M, Dammerer D, Zantop T, Landgraeber S, Nehrer S. Minced cartilage for focal cartilage defects-A comprehensive systematic review of surgical techniques in clinical studies, animal studies and basic research studies. Knee Surg Sports Traumatol Arthrosc. 2025 Oct;33(10):3571-3591. doi: 10.1002/ksa.12608. Epub 2025 Mar 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank WEIN principal investigator
Louis Pasteur Santé Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of focal cartilage lesions of the knee: micro-fracture and Minced Cartilage Implantation (MCI) in people with Focal Cartilage Lesions of the Knee, run by Louis Pasteur Santé Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte BOUVET (+33383188340, charlotte.bouvet@louispasteursante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone grafting (time frame: at 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07641868, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.