NCT05685316

COPLA® Cartilage Implant Pilot Clinical Trial

Pilot Clinical Trial to Evaluate the Preliminary Safety and Performance of COPLA® for Treatment of Cartilage Defects

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Askel Healthcare Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-12-23
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-01-17
• Last updated: 2024-11-06

Locations

6 sites across 3 countries: Estonia, Finland, Sweden