Knee Chondral LesionPhase 4NCT01282034
Study for the Treatment of Knee Chondral and Osteochondral Lesions
A Phase 4 study testing Marrow stimulation - Drilling or Microfractures and MaioRegen Surgery in people with Knee Chondral Lesion and Knee Osteochondral Lesion, run by Fin-Ceramica Faenza Spa at 10 sites in 9 countries.
Trial summary
INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Chondral Lesion, Knee Osteochondral Lesion
- What is being tested?
- Marrow stimulation - Drilling or Microfractures and MaioRegen Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 10 sitesin 9 countries
- Study dates
- Jan 2011to Feb 2016
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients provided written informed consent;
- Patients aged between 18 and 60 years;
- Knee symptomatic chondral lesion of grade III/IV (according to Outerbridge Classification) or osteochondral lesion;
- Not re-fixable OCD lesions;
- Lesion between 2-9 cm2;
- Single lesion;
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- Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
- Male or female patients;
- Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.
Who cannot join
- Patients incapable to understanding and will;
- Patients participating in previous, concurrent or not, trials (ongoing or completed within 3 months);
- Patients surgically treated for the same defect within one year;
- Known allergy to collagen or calcium-phosphates;
- Patients affected by malignancy;
- Patients affected by metabolic or thyroid disorders;
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- Patients used to alcohol or drug (medication) abuse;
- Patients affected by advanced osteoarthritis (Kellgren-Lawrence grade ≥3);
- Patients affected by synovitis;
- Untreated patellofemoral malalignment;
- Varus or valgus malalignment exceeding 5°;
- Body Mass Index > 30;
- Patients previously treated for total or partial meniscectomy (>50% of the meniscus dimension);
- Multiple lesions;
- Kissing lesions;
- Chondral/osteochondral tibial plate defects;
- Concomitant menisci and chondral/osteochondral defects to be treated;
- Untreated knee ligament instability.
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Italy2 sites
Istituti Ortopedici Rizzoli
Bologna, Bologna, 40136
Ospedal Sacro Cuore Don Calabria
Negrar, Verona, 37024
Germany1 site
University Medical Center
Freiburg im Breisgau, Freiburg Im Breisgau, 79098
About this study
Official title: Multicenter Randomized Controlled Trial for the Treatment of Knee Chondral and Osteochondral Lesions: Marrow Stimulation Techniques vs MaioRegen
INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques.
MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a clinical study.
Read more
OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to reference standard surgical techniques (microfractures and subchondral drilling) for the treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as innovative surgical approach.
STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm, single-blind and involves eleven European centres and 150 patients. Eligible subjects will be randomly allocated to one of the two treatment groups: control group, treated with marrow stimulation techniques, and treatment group, treated with MaioRegen® implant.
Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the entry criteria for the trial. Before enrolment, each subject should declare his voluntary participation to the study by informed consent signature.
Arthroscopic control will be carried out immediately before the randomization and thus surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing the recruitment.
For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and during each follow-up visit the Case Report Form (CRF) will be filled in the specific section.
Within the CRF, at each follow-up section, commonly used and specific scores will be assigned for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System).
Patients selected will be randomized to undergo one of two study groups, as prescribed by the randomization list.
Read the detailed description
Post-operative MRI exams will be carried out for each patient during the follow-up visit, at 6, 12 and 24 months post-op., and centrally blind evaluated by two senior radiologists.
STATISTICS The study has been designed to demonstrate the superiority of MaioRegen® compared to marrow stimulation techniques.
On the basis of previous evidence and, assuming a minimum difference in the modification of the IKDC Subjective Knee Evaluation Score between MaioRegen® and the control therapy, the sample size was estimated in 74 patients for group (power=90%, first type error α=5%, drop-outs=10%), for a total sample size of 148 subjects.
The analysis of the primary end-point will be the evaluation of change from baseline to two years, in IKDC Subjective Knee Evaluation Score, comparing the results between the two groups.
Secondary end-points (functional improvement, quality of life improvement, tissue regeneration) will undergo the same analyses as the primary end-point, for each follow-up visit.
Frequency tables will be provided for overall judgement of the treatment. The incidence and gravity frequency of eventual events after surgery will be tabulated.
The study will be conducted after approval by the ethics committee board of each centre and possibly by the national competent authorities.
- Conditions
- Knee Chondral Lesion, Knee Osteochondral Lesion
- Being tested
- Marrow stimulation - Drilling or Microfractures, MaioRegen Surgery
- Keywords
- CHONDRAL, OSTEOCHONDRAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marrow stimulation - Drilling or MicrofracturesProcedure or surgery
Also called subchondral Drilling, Steadman's Microfractures
Subchondral drilling consists in penetration of the subchondral bone endplate and creation of holes, and it is mostly indicated for the treatment of osteochodral lesion.
Microfractures (MF), according to Steadman's technique, are one of the most used first-line treatment for cartilage injuries, and commonly considered safe and effective.
MaioRegen SurgeryDevice
Also called osteochondral scaffold
MaioRegen® (is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions.
| Study group | Role | What they receive |
|---|---|---|
| Marrow stimulation | Active comparator | Not described Receives: Procedure: Marrow stimulation - Drilling or Microfractures |
| Medical device: MaioRegen | Experimental | Not described Receives: Device: MaioRegen Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC Subjective Knee Evaluation Form-2000
Measured: two years
Secondary outcomes (5)
IKDC Knee Examination Form-2000
Measured: six months and one year
KOOS
Measured: six months, one year, two years
Tegner score
Measured: six months, one year, two years
VAS (Visual Analogue Scale) for pain evaluation
Measured: six months, one year, two years
MRI exam and MOCART score
Measured: six months, one year, two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Chondral LesionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fin-Ceramica Faenza Spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurilio Marcacci, Prof., Principal investigator, Istituti Ortopedici Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282034
- Sponsor's protocol ID
- ORT-12
- Status last verified
- Aug 2016
- First submitted
- 21 Jan 2011
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial for the Treatment of Knee Chondral and Osteochondral Lesions: Marrow Stimulation Techniques vs MaioRegen
- ClinicalTrials.gov ID
- NCT01282034
- Acronym / sponsor ID
- ORT-12
- Conditions
- Knee Chondral Lesion, Knee Osteochondral Lesion
- Keywords
- CHONDRAL, OSTEOCHONDRAL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Fin-Ceramica Faenza SpaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 24 Jan 2011 (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.
INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques.
MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a clinical study.
OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to reference standard surgical techniques (microfractures and subchondral drilling) for the treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as innovative surgical approach.
STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm, single-blind and involves eleven European centres and 150 patients. Eligible subjects will be randomly allocated to one of the two treatment groups: control group, treated with marrow stimulation techniques, and treatment group, treated with MaioRegen® implant.
Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the entry criteria for the trial. Before enrolment, each subject should declare his voluntary participation to the study by informed consent signature.
Arthroscopic control will be carried out immediately before the randomization and thus surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing the recruitment.
For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and during each follow-up visit the Case Report Form (CRF) will be filled in the specific section.
Within the CRF, at each follow-up section, commonly used and specific scores will be assigned for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System).
Patients selected will be randomized to undergo one of two study groups, as prescribed by the randomization list.
Detailed description
Post-operative MRI exams will be carried out for each patient during the follow-up visit, at 6, 12 and 24 months post-op., and centrally blind evaluated by two senior radiologists.
STATISTICS The study has been designed to demonstrate the superiority of MaioRegen® compared to marrow stimulation techniques.
On the basis of previous evidence and, assuming a minimum difference in the modification of the IKDC Subjective Knee Evaluation Score between MaioRegen® and the control therapy, the sample size was estimated in 74 patients for group (power=90%, first type error α=5%, drop-outs=10%), for a total sample size of 148 subjects.
The analysis of the primary end-point will be the evaluation of change from baseline to two years, in IKDC Subjective Knee Evaluation Score, comparing the results between the two groups.
Secondary end-points (functional improvement, quality of life improvement, tissue regeneration) will undergo the same analyses as the primary end-point, for each follow-up visit.
Frequency tables will be provided for overall judgement of the treatment. The incidence and gravity frequency of eventual events after surgery will be tabulated.
The study will be conducted after approval by the ethics committee board of each centre and possibly by the national competent authorities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marrow stimulation | Active comparator | Procedure: Marrow stimulation - Drilling or Microfractures |
| Medical device: MaioRegen | Experimental | Device: MaioRegen Surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients provided written informed consent;
- Patients aged between 18 and 60 years;
- Knee symptomatic chondral lesion of grade III/IV (according to Outerbridge Classification) or osteochondral lesion;
- Not re-fixable OCD lesions;
- Lesion between 2-9 cm2;
Key exclusion criteria (18 listed)
- Patients incapable to understanding and will;
- Patients participating in previous, concurrent or not, trials (ongoing or completed within 3 months);
- Patients surgically treated for the same defect within one year;
- Known allergy to collagen or calcium-phosphates;
- Patients affected by malignancy;
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 |
|---|---|---|
| Marrow stimulation - Drilling or MicrofracturesAlso: subchondral Drilling, Steadman's MicrofracturesSubchondral drilling consists in penetration of the subchondral bone endplate and creation of holes, and it is mostly indicated for the treatment of osteochodral lesion. Microfractures (MF), according to Steadman's technique, are one of the most used first-line treatment for cartilage injuries, and commonly considered safe and effective. | Procedure or surgery | Marrow stimulation |
| MaioRegen SurgeryAlso: osteochondral scaffoldMaioRegen® (is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions. | Device | Medical device: MaioRegen |
Primary outcome
IKDC Subjective Knee Evaluation Form-2000
Time frame: two years
5 secondary outcomes
IKDC Knee Examination Form-2000
Time frame: six months and one year
KOOS
Time frame: six months, one year, two years
Tegner score
Time frame: six months, one year, two years
VAS (Visual Analogue Scale) for pain evaluation
Time frame: six months, one year, two years
MRI exam and MOCART score
Time frame: six months, one year, two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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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.
Maurilio Marcacci, Prof. principal investigator
Istituti Ortopedici Rizzoli
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Marrow stimulation - Drilling or Microfractures and MaioRegen Surgery in people with Knee Chondral Lesion and Knee Osteochondral Lesion, run by Fin-Ceramica Faenza Spa at 10 sites in 9 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Austria, Belgium, Germany, Norway and 4 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IKDC Subjective Knee Evaluation Form-2000 (time frame: two 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 5 Aug 2016.