Cartilage or Osteochondral Defects in the KneeNCT05685316
COPLA® Cartilage Implant Pilot Clinical Trial
A study testing COPLA® cartilage implant in people with Cartilage or Osteochondral Defects in the Knee, run by Askel Healthcare Ltd at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cartilage or Osteochondral Defects in the Knee
- What is being tested?
- COPLA® cartilage implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 23 Dec 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 31Show fewer
- 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;
- Need for any concomitant surgical intervention with the cartilage repair;
- Inflammatory joint disease of the index or contralateral knee;
- Any known history of inflammatory arthropathy or crystal-deposition arthropathy;
- Active acute or chronic intra-articular or osseous infection of the index knee;
- Any evidence of active infection anywhere in the body;
- Inflammatory joint disease;
- Body Mass Index (BMI) ≥ 30;
- 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;
- Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed;
- Chemotherapy in the past 12 months;
- Any known tumor of the index knee;
- Subject known to be pregnant or lactating;
- Participation in other clinical trials within 60 days prior to this trial or concurrent with this trial;
- Prisoners;
- Known substance or alcohol abuse; OR
- Current nicotine users
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Finland4 sites
Mehiläinen
Helsinki
Terveystalo
Helsinki
Central Finland Health Care District
Jyväskylä
Terveystalo
Jyväskylä
About this study
Official title: Pilot Clinical Trial to Evaluate the Preliminary Safety and Performance of COPLA® for Treatment of Cartilage Defects
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.
Read the 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.
- Being tested
- COPLA® cartilage implant
- Keywords
- Cartilage, Cartilage lesion, Cartilage defect, Knee cartilage, Cartilage repair, Chondral defect, Osteochondral defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPLA® cartilage implantDevice
In the investigation, the subjects will receive COPLA® device during normal clinical practice for cartilage repair surgery of the knee with bone marrow stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: COPLA® cartilage implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events (SAE)
Safety - Measured by number of SAE and evaluated over the course of the clinical investigation
Measured: From pre-operative baseline up to 24-month follow-up visit
Secondary outcomes (4)
Defect filling
Measured by the change in repair tissue quality evaluated according to Magnetic Resonance Imaging (MRI) Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART 2.0)
Measured: From pre-operative baseline up to 24-month follow-up visit
Change in pain score
Measured by the change in pain score according to the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale (scale from never to always).
Measured: From pre-operative baseline up to 24-month follow-up visit
Functional outcome
Measured by the change in joint function scores according to the KOOS joint function subscales (degree of difficulty, scale from none to extreme).
Measured: From pre-operative baseline up to 24-month follow-up visit
Change in Quality of life
Measured by the change to 12-Item Short Form Survey (SF-12) Health Survey (scale from excellent to poor).
Measured: From pre-operative baseline up to 24-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start23 Dec 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage or Osteochondral Defects in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Askel Healthcare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685316
- Sponsor's protocol ID
- STU06-001
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial to Evaluate the Preliminary Safety and Performance of COPLA® for Treatment of Cartilage Defects
- ClinicalTrials.gov ID
- NCT05685316
- Acronym / sponsor ID
- STU06-001
- Keywords
- Cartilage, Cartilage lesion, Cartilage defect, Knee cartilage, Cartilage repair, Chondral defect, Osteochondral defect
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Askel Healthcare LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPLA® cartilage implant | Experimental | Device: COPLA® cartilage implantThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (31 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPLA® cartilage implantIn the investigation, the subjects will receive COPLA® device during normal clinical practice for cartilage repair surgery of the knee with bone marrow stimulation. | Device | COPLA® cartilage implant |
Primary outcome
Number of Serious Adverse Events (SAE)
Time frame: From pre-operative baseline up to 24-month follow-up visit
Safety - Measured by number of SAE and evaluated over the course of the clinical investigation
4 secondary outcomes
Defect filling
Time frame: From pre-operative baseline up to 24-month follow-up visit
Change in pain score
Time frame: From pre-operative baseline up to 24-month follow-up visit
Functional outcome
Time frame: From pre-operative baseline up to 24-month follow-up visit
Change in Quality of life
Time frame: From pre-operative baseline up to 24-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Cartilage or Osteochondral Defects in the Knee
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPLA® cartilage implant in people with Cartilage or Osteochondral Defects in the Knee, run by Askel Healthcare Ltd at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Estonia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (SAE) (time frame: From pre-operative baseline up to 24-month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.