ASKEL Cartilage Implant Pilot Clinical Trial

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 50 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

20 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (6)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

6 locations

Study team and timeline

Lead sponsor

Askel Healthcare Ltd

Study start

Dec 23, 2022 Actual

Primary completion

May 5, 2026 Actual

Study completion

2029-12 Estimated

First posted

Jan 17, 2023 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.