Osteochondral DefectsOMCMNCT01209390
A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
An observational study of Osteochondral Defects, run by TiGenix n.v. at 4 sites in 4 countries.
Trial summary
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondral Defects
- What is being tested?
- Chondromimetic
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2010to Apr 2016
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in selected centres, primary or secondary care, first line or referral treatment.
Who may be able to join
- Signed patient informed consent
- Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
- Agree to actively participate in a rehabilitation protocol
Who cannot join
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative joint disease
- Pregnancy
- Presence of infection at the site or in the joint space (e.g. osteomyelitis)
- Diagnosis rheumatoidism
Show all 12Show fewer
- Advanced osteoarthritis as judged by the surgeon
- Drug and/or alcohol abuse
- Hypercalcemia
- Known allergy to any of the components of the device (e.g. bovine collagen)
- Bleeding disorders of any etiology
- Steroidal or immunosuppressive maintenance therapy
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.
The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.
The secondary objectives are:
- Clinical outcome as assessed by patient reported EuroQoL-5D
- Structural repair as assessed by MRI
- The number of treatment failures and the time to treatment failure
- The ease of use of ChondroMimetic as reported by the surgeon
- Conditions
- Osteochondral Defects
- Being tested
- Chondromimetic
- Keywords
- osteochondral, regenerative, repair, cartilage lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChondromimeticDevice
Also called Osteochondral repair plug, CM
The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage.
The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate.
| Study group | Role | What they receive |
|---|---|---|
| Osteochondral lesions | Patients with osteochondral lesions in the knee, the ankle, or other joint Receives: Device: Chondromimetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data
Safety data as measured by adverse device reactions
Measured: on ongoing basis up to 3 years
Secondary outcomes (3)
EuroQoL-5D
The EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension
Measured: baseline, 6, 12, 24, 36 months
MRI
Structural repair will be assessed by MRI. The available MRIs will be collected and scored by an independent radiologist, using the published MOCART score , and one additional item, level of the subchondral bone plate.
Measured: baseline, 12, 24, 36 months
Failure rate
Treatment failure is defined as "a re-intervention on the index lesion, prompted by persistence or recurrence of symptoms related to the index knee". The date of failure is the actual date of re-intervention.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2015 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral DefectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- TiGenix n.v.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laszlo Hangody, MD, Principal investigator, Uzsoki Hospital, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209390
- Sponsor's protocol ID
- OMCM-2010-01
- Acronym
- OMCM
- Status last verified
- Sep 2011
- First submitted
- 6 Aug 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
- ClinicalTrials.gov ID
- NCT01209390
- Acronym / sponsor ID
- OMCM / OMCM-2010-01
- Conditions
- Osteochondral Defects
- Keywords
- osteochondral, regenerative, repair, cartilage lesion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- TiGenix n.v.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 27 Sep 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 objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.
The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.
The secondary objectives are:
- Clinical outcome as assessed by patient reported EuroQoL-5D
- Structural repair as assessed by MRI
- The number of treatment failures and the time to treatment failure
- The ease of use of ChondroMimetic as reported by the surgeon
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteochondral lesions | – | Device: ChondromimeticPatients with osteochondral lesions in the knee, the ankle, or other joint |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in selected centres, primary or secondary care, first line or referral treatment.
Key inclusion criteria (3 listed)
- Signed patient informed consent
- Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
- Agree to actively participate in a rehabilitation protocol
Key exclusion criteria (12 listed)
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative joint disease
- Pregnancy
- Presence of infection at the site or in the joint space (e.g. osteomyelitis)
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 |
|---|---|---|
| ChondromimeticAlso: Osteochondral repair plug, CMThe Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage. The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate. | Device | Osteochondral lesions |
Primary outcome
Safety data
Time frame: on ongoing basis up to 3 years
Safety data as measured by adverse device reactions
3 secondary outcomes
EuroQoL-5D
Time frame: baseline, 6, 12, 24, 36 months
MRI
Time frame: baseline, 12, 24, 36 months
Failure rate
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
Related trials for Osteochondral Defects
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A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
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A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
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)
Not yet recruitingObservational study
Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial
Cartilage Injury, Cartilage Disease
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.
Laszlo Hangody, MD principal investigator
Uzsoki Hospital, Budapest, Hungary
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteochondral Defects, run by TiGenix n.v. at 4 sites in 4 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 3 inclusion and 12 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 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, Hungary, United Kingdom. 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: Slow recruitment rate). 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?
Safety data (time frame: on ongoing basis up to 3 years). 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 20 Sep 2011.