Osteochondral Lesion of TalusNCT02345564
Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
A study testing implantation of MaioRegen fleece into osteochondral lesion in people with Osteochondral Lesion of Talus and Degenerative Lesion of Articular Cartilage of Knee, run by Barmherzige Brüder Eisenstadt.
Trial summary
Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects. This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Osteochondral Lesion of Talus, Degenerative Lesion of Articular Cartilage of Knee
- What is being tested?
- implantation of MaioRegen fleece into osteochondral lesion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Dec 2015
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- single osteochondral lesion in knee/ankle (2-4 sq cm)
Who cannot join
- multiple osteochondral lesions
- pre-existing injuries/arthropathies
About this study
Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.
This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.
- Being tested
- implantation of MaioRegen fleece into osteochondral lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of MaioRegen fleece into osteochondral lesionDevice
Also called MaioRegen Fin-Ceramica Faenza S.p.A.
arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece
| Study group | Role | What they receive |
|---|---|---|
| osteochondral lesions in knee/ankle | Other | patients with traumatic and atraumatic osteochondral lesions in knee/ankle, implantation of MaioRegen fleece into osteochondral lesion Receives: Device: implantation of MaioRegen fleece into osteochondral lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI imaging - gap between cartilage-implant surface in mm
ingrowth of fleece into the cartilage
Measured: 18 months post surgery
Secondary outcomes (5)
clinical outcome measurement
Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index
Measured: pre-surgery
clinical outcome measurement
Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index
Measured: 6 months post-surgery
clinical outcome measurement
Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index
Measured: 12 months post-surgery
clinical outcome measurement
Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index
Measured: 18 months post-surgery
clinical outcome measurement
Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot\&Ankle Disability Index
Measured: 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondral Lesion of TalusStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barmherzige Brüder Eisenstadt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Kellner, MD, Principal investigator, Barmherzige Brueder EisenstadtHarald Boszotta, MD, Study chair, Barmherzige Brueder Eisenstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345564
- Sponsor's protocol ID
- BBEMaRe 001
- Status last verified
- Jul 2015
- First submitted
- 11 Sep 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery
- ClinicalTrials.gov ID
- NCT02345564
- Acronym / sponsor ID
- BBEMaRe 001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Barmherzige Brüder EisenstadtUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Jan 2015 (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.
Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects.
This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteochondral lesions in knee/ankle | Other | Device: implantation of MaioRegen fleece into osteochondral lesionpatients with traumatic and atraumatic osteochondral lesions in knee/ankle, implantation of MaioRegen fleece into osteochondral lesion |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- single osteochondral lesion in knee/ankle (2-4 sq cm)
Key exclusion criteria (2 listed)
- multiple osteochondral lesions
- pre-existing injuries/arthropathies
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 |
|---|---|---|
| implantation of MaioRegen fleece into osteochondral lesionAlso: MaioRegen Fin-Ceramica Faenza S.p.A.arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece | Device | osteochondral lesions in knee/ankle |
Primary outcome
MRI imaging - gap between cartilage-implant surface in mm
Time frame: 18 months post surgery
ingrowth of fleece into the cartilage
5 secondary outcomes
clinical outcome measurement
Time frame: pre-surgery
clinical outcome measurement
Time frame: 6 months post-surgery
clinical outcome measurement
Time frame: 12 months post-surgery
clinical outcome measurement
Time frame: 18 months post-surgery
clinical outcome measurement
Time frame: 24 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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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.
Richard Kellner, MD principal investigator
Barmherzige Brueder Eisenstadt
Harald Boszotta, MD study chair
Barmherzige Brueder Eisenstadt
Questions about this trial
What is this clinical trial studying?
A study testing implantation of MaioRegen fleece into osteochondral lesion in people with Osteochondral Lesion of Talus and Degenerative Lesion of Articular Cartilage of Knee, run by Barmherzige Brüder Eisenstadt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
MRI imaging - gap between cartilage-implant surface in mm (time frame: 18 months post surgery). 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 22 Jul 2015.