Cartilage DefectNCT01110070
ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee
A study testing ChonDux in people with Cartilage Defect, run by Zimmer Biomet at 7 sites in 3 countries.
Trial summary
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cartilage Defect
- What is being tested?
- ChonDux
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A standing radiograph of the knee showing a Kellgren score of 0-2
- Body mass index ≤33
- An Outerbridge score of III or IV without need for bone graft
- A meniscus with no more than partial resection in the affected knee
Who cannot join
- Passive motion deficit of the knee (>5º of extension, >15º of flexion)
- Moderate or severe osteoarthritis
- Diabetes mellitus (IDDM Type 1)
- Patellofemoral instability
- Malalignment with > 5° valgus or varus compared to contralateral knee
- Active osteomyelitis
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany3 sites
Krakenhaus Altentreptow
Altentreptow
Orthopedic and Pain Center Freiberg
Freiberg
University Mannheim
Mannheim
Netherlands2 sites
Meander Medical Center
Baarn
Tergooiziekenhuizen
Hilversum
About this study
Official title: Pivotal Study in Europe for CE Mark
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.
Read the detailed description
Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.
- Conditions
- Cartilage Defect
- Being tested
- ChonDux
- Keywords
- articular, cartilage, microfracture, knee pain, cartilage repair, Subjects with an articular cartilage defect in the knee.
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChonDuxDevice
Comparison of ChonDux plus microfracture to microfracture only
ChonDuxDevice
single use device
| Study group | Role | What they receive |
|---|---|---|
| ChonDux plus microfracture | Experimental | Not described Receives: Device: ChonDux |
| Microfracture | Active comparator | Not described Receives: Device: ChonDux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defect fill at 6 months determined by magnetic resonance imaging (MRI)
Measured: 6 months
Secondary outcomes (3)
Pain score (VAS)
Measured: 6 months
Knee function as assessed by the IKDC questionnaire
Measured: 6 months
SF-36 Health Survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2012
Why it stopped: Enrollment suspended; follow up continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cartilage DefectStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110070
- Sponsor's protocol ID
- CCS-08
- Status last verified
- Jul 2017
- First submitted
- 22 Apr 2010
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolf MT, Zhang H, Sharma B, Marcus NA, Pietzner U, Fickert S, Lueth A, Albers GHR, Elisseeff JH. Two-Year Follow-Up and Remodeling Kinetics of ChonDux Hydrogel for Full-Thickness Cartilage Defect Repair in the Knee. Cartilage. 2020 Oct;11(4):447-457. doi: 10.1177/1947603518800547. Epub 2018 Oct 3.
PubMed 30280586
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study in Europe for CE Mark
- ClinicalTrials.gov ID
- NCT01110070
- Acronym / sponsor ID
- CCS-08
- Conditions
- Cartilage Defect
- Keywords
- articular, cartilage, microfracture, knee pain, cartilage repair, Subjects with an articular cartilage defect in the knee.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment suspended; follow up continue
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Apr 2010 (estimated)
- 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.
The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.
Detailed description
Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChonDux plus microfracture | Experimental | Device: ChonDux |
| Microfracture | Active comparator | Device: ChonDux |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A standing radiograph of the knee showing a Kellgren score of 0-2
- Body mass index ≤33
- An Outerbridge score of III or IV without need for bone graft
- A meniscus with no more than partial resection in the affected knee
Key exclusion criteria (6 listed)
- Passive motion deficit of the knee (>5º of extension, >15º of flexion)
- Moderate or severe osteoarthritis
- Diabetes mellitus (IDDM Type 1)
- Patellofemoral instability
- Malalignment with > 5° valgus or varus compared to contralateral knee
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 |
|---|---|---|
| ChonDuxComparison of ChonDux plus microfracture to microfracture only | Device | ChonDux plus microfracture, Microfracture |
| ChonDuxsingle use device | Device | Microfracture |
Primary outcome
Defect fill at 6 months determined by magnetic resonance imaging (MRI)
Time frame: 6 months
3 secondary outcomes
Pain score (VAS)
Time frame: 6 months
Knee function as assessed by the IKDC questionnaire
Time frame: 6 months
SF-36 Health Survey
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Enrollment suspended; follow up continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Derived from this study: PubMed 30280586Wolf MT, Zhang H, Sharma B, Marcus NA, Pietzner U, Fickert S, Lueth A, Albers GHR, Elisseeff JH. Two-Year Follow-Up and Remodeling Kinetics of ChonDux Hydrogel for Full-Thickness Cartilage Defect Repair in the Knee. Cartilage. 2020 Oct;11(4):447-457. doi: 10.1177/1947603518800547. Epub 2018 Oct 3.
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChonDux in people with Cartilage Defect, run by Zimmer Biomet at 7 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Netherlands. 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?
The study was stopped early (reason given: Enrollment suspended; follow up continue). Results are not available in the source record.
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?
Defect fill at 6 months determined by magnetic resonance imaging (MRI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110070, which also lists 1 linked publication.
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 7 Jul 2017.