Activo, sin reclutamientoNCT05685316Registro de ClinicalTrials.gov

ASKEL Cartilage Implant Pilot Clinical Trial

Cartilage or Osteochondral Defects in the Knee

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 50 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 20 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This is a first-in-human clinical, open label, non-randomized, prospective investigation to assess the initial safety and performance of the ASKEL Cartilage Implant. In the investigation, the patients will receive ASKEL device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.

Leer la descripción completa

Included subjects will be symptomatic patients between the ages 18 and 50 years with a single contained chondral or osteochondral defect located on the femoral condyle and graded as III or IV according to the International Cartilage Repair Society (ICRS) grading system. Subjects with known health related risks or certain recent surgical or medical interventions will be excluded.

The primary objective of the investigation is to confirm that ASKEL device is safe for humans. The secondary objectives relate to the performance of the device after it is placed into the knee joint during surgery. Focus points of secondary objectives will be facilitation of mobility and non-restricted weight-bearing of the operated leg as well as the identification of repair tissue growth at the lesion site.

Post-operative follow-up is planned for 24 months after surgery. Subject will come for scheduled visits at 6-week, 3-month, 6-month, 12-month, and 24-month timepoints. Extension part will continue the investigation with additional follow-up visit at 36-month and 60-month post operation.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Single contained symptomatic chondral or osteochondral defect located on the femoral condyle graded as ICRS III or IV observed in the preoperative MRI;
2. Minimum defect size 1 cm2 post-debridement;
3. Aged between 18 and 50 at the time of enrollment;
4. Osteoarthritis of the index knee graded 0 or I according to the Kellgren-Lawrence Grading in posterior-anterior knee radiography with full weight bearing;
5. Subject is able and willing to give informed consent; AND
6. Subject is physically and mentally willing and able to comply with the post-operative rehabilitation protocol, questionnaires, and scheduled clinical and radiographic visits

Exclusion Criteria:

1. Defect size over 4 cm2 according to arthroscopy during operation;
2. Subchondral defect depth over 4 mm according to pre-operative MRI;
3. Osteoarthritis of the index knee grades II or above according to the Kellgren-Lawrence Grading;
4. History of allergic reaction or intolerance of materials containing polylactide and/or bovine collagen;
5. Presence of an additional articular cartilage lesions in the femur, tibia or the patella, ICRS grades III or above observed in the preoperative MRI or during the final intraoperative arthroscopic evaluation;
6. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteochondrosis, osteoporosis, chondrodysplasia or osteogenesis imperfecta;
7. Any previous surgical treatment in the index knee in the past 12 months;
8. Any previous intra-articular injections in the index knee in the past 3 months;
9. Systemic corticosteroid therapy in the past 1 month;
10. Presence of an untreated clinically significant meniscal tear;
11. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure;
12. Prior meniscal resection \> 50%;
13. Untreated Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) deficiency: collateral and rotational;
14. Anteroposterior and/or varus/valgus instability on clinical testing;
15. Asymmetrical collateral stability in full extension and 20-degree flexion on clinical testing;
16. Need for any concomitant surgical intervention with the cartilage repair;
17. Inflammatory joint disease of the index or contralateral knee;
18. Any known history of inflammatory arthropathy or crystal-deposition arthropathy;
19. Active acute or chronic intra-articular or osseous infection of the index knee;
20. Any evidence of active infection anywhere in the body;
21. Inflammatory joint disease;
22. Body Mass Index (BMI) ≥ 30;
23. History of any significant systemic disease, such as but not limited to: human immunodeficiency virus (HIV), hepatitis, human T-lymphotropic virus (HTLV), syphilis, and coagulopathies;
24. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed;
25. Chemotherapy in the past 12 months;
26. Any known tumor of the index knee;
27. Subject known to be pregnant or lactating;
28. Participation in other clinical trials within 60 days prior to this trial or concurrent with this trial;
29. Prisoners;
30. Known substance or alcohol abuse; OR
31. Current nicotine users

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

ASKEL Cartilage Implant

The potential subjects will be screened against inclusion and exclusion criteria. If deemed eligible, they will be consented and enrolled. The enrolled subjects will receive ASKEL device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.

Device: ASKEL Cartilage Implant

ASKEL Cartilage Implant DEVICE

In the investigation, the subjects will receive ASKEL device during normal clinical practice for cartilage repair surgery of the knee with bone marrow stimulation.

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