COPLA® Cartilage Implant Pilot Clinical Trial

NCT05685316 | Active Not Recruiting

• 1 other identifier: STU06-001
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

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.

Conditions

Cartilage or Osteochondral Defects in the Knee

Keywords

Cartilage; Cartilage lesion; Cartilage defect; Knee cartilage; Cartilage repair; Chondral defect; Osteochondral defect

Outcome Measures

Primary Outcomes (1)

• Number of Serious Adverse Events (SAE)

  Safety - Measured by number of SAE and evaluated over the course of the clinical investigation

  From pre-operative baseline up to 24-month follow-up visit

Secondary Outcomes (4)

• Defect filling

  From pre-operative baseline up to 24-month follow-up visit

• Change in pain score

  From pre-operative baseline up to 24-month follow-up visit

• Functional outcome

  From pre-operative baseline up to 24-month follow-up visit

• Change in Quality of life

  From pre-operative baseline up to 24-month follow-up visit

Study Arms (1)

COPLA® cartilage implant

EXPERIMENTAL

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.

Device: COPLA® cartilage implant

Interventions

COPLA® cartilage implant 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.

COPLA® cartilage implant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Defect size over 4 cm2 according to arthroscopy during operation;
• Subchondral defect depth over 4 mm according to pre-operative MRI;
• Osteoarthritis of the index knee grades II or above according to the Kellgren-Lawrence Grading;
• History of allergic reaction or intolerance of materials containing polylactide and/or bovine collagen;
• 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;
• Any known systemic cartilage and/or bone disorder, such as but not limited to, osteochondrosis, osteoporosis, chondrodysplasia or osteogenesis imperfecta;
• Any previous surgical treatment in the index knee in the past 12 months;
• Any previous intra-articular injections in the index knee in the past 3 months;
• Systemic corticosteroid therapy in the past 1 month;
• Presence of an untreated clinically significant meniscal tear;
• Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure;
• Prior meniscal resection \> 50%;
• Untreated Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) deficiency: collateral and rotational;
• Anteroposterior and/or varus/valgus instability on clinical testing;
• Asymmetrical collateral stability in full extension and 20-degree flexion on clinical testing;

Sponsors & Collaborators

• Askel Healthcare Ltd: lead

Study Sites (6)

Tartu University Hospital

Tartu, Estonia

Location

Mehiläinen

Helsinki, Finland

Location

Terveystalo

Helsinki, Finland

Location

Central Finland Health Care District

Jyväskylä, Finland

Location

Terveystalo

Jyväskylä, Finland

Location

Sahlgrenska University hospital

Gothenburg, Mölndal, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 17, 2023
• Study Start: December 23, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); ES (1); FI (4)