COPLA® Cartilage Implant Pilot Clinical Trial

NCT ID: NCT05685316

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-23
• Study Completion Date: 2026-09-30

Brief Summary

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

Detailed Description

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 COPLA® 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.

Conditions

Cartilage or Osteochondral Defects in the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPLA® 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 COPLA® device during normal clinical practice for cartilage repair surgery with bone marrow stimulation.

Group Type: EXPERIMENTAL

COPLA® cartilage implant

Intervention Type: DEVICE

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

Interventions

COPLA® cartilage implant

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Askel Healthcare Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tartu University Hospital

Tartu, , Estonia

Mehiläinen

Helsinki, , Finland

Terveystalo

Helsinki, , Finland

Central Finland Health Care District

Jyväskylä, , Finland

Terveystalo

Jyväskylä, , Finland

Sahlgrenska University hospital

Gothenburg, Mölndal, Sweden

Countries

Estonia; Finland; Sweden

Other Identifiers

STU06-001

Identifier Type: -

Identifier Source: org_study_id