Bone Marrow EdemaPhase 4BME-TARGETNCT03112122
Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute
A Phase 4 study testing autologous bone marrow concentrate, bone substitute i-FactorTM and core decompression in people with Bone Marrow Edema, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- autologous bone marrow concentrate, bone substitute i-FactorTM and core decompression
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2016to 31 Dec 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 75 years;
- Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
- Failure after at least two months of a conservative treatment;
- Single BME areas involving a single compartment of the knee;
- Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
- Signature of informed consent.
Who cannot join
- Patients incapable of discernment;
- History of allergy to calcium phosphates;
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients suffering of metabolic disorders of the thyroid;
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- Patients with history of abuse of alcohol, drugs or medication;
- Patients with advanced osteoarthritis (Kellgren-Lawrence grade> 3);
- Body Mass Index> 35;
- BME that involve more than one compartment;
- Patients with trauma in the 6 months prior to the intervention. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute
Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.
Read the detailed description
The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.
- Conditions
- Bone Marrow Edema
- Being tested
- autologous bone marrow concentrate, bone substitute i-FactorTM, core decompression
- Keywords
- Bone Marrow Edema, Mesenchymal Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow concentrateBiological
injection of autologous bone marrow concentrate
bone substitute i-FactorTMBiological
subchondral injections of i-FactorTM
core decompressionProcedure or surgery
subchondral anterograde drilling
| Study group | Role | What they receive |
|---|---|---|
| core decompression technique | Active comparator | The standard surgical technique is the subchondral anterograde drilling, which permit a revascularization of the Bone Marrow Edema (BME) and a reduction of the intramedullary pressure (core decompression). Receives: Procedure: core decompression |
| bone substitution (i-FactorTM) | Experimental | i-FactorTM is a combination of the mineral component of bone (Anorganic Bone Mineral) with a peptide replicating the cell-binding domain of Type-I collagen (P-15). It has been used in bone defects and in spine fusion providing good clinical results. Thus, i-FactorTM could be a valid and efficient bone substitute to treat BMLs with subchondral injections. Receives: Biological: bone substitute i-FactorTM |
| injections of autologous Bone Marrow Concentrate (BMC) | Experimental | injections of autologous BMC. Receives: Biological: autologous bone marrow concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Visual Analogue Scale (VAS) score
improvement in VAS score from baseline to follow up
Measured: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Secondary outcomes (3)
International Knee Documentation Committee (IKDC) subjective score
improvement in IKDC subjective score from baseline to follow up
Measured: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Knee Injury and Osteoarthritis Outcome (KOOS) Score
improvement in KOOS score from baseline to follow up
Measured: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Tegner Activity Level Scale
improvement in activity level scale from baseline to follow up
Measured: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start11 Mar 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, three-arm, double-blind study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Balboni, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112122
- Sponsor's protocol ID
- BME-TARGET
- Acronym
- BME-TARGET
- Status last verified
- Aug 2018
- First submitted
- 30 Mar 2017
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- 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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute
- ClinicalTrials.gov ID
- NCT03112122
- Acronym / sponsor ID
- BME-TARGET / BME-TARGET
- Conditions
- Bone Marrow Edema
- Keywords
- Bone Marrow Edema, Mesenchymal Stem Cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Apr 2017 (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.
Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.
Detailed description
The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, controlled, three-arm, double-blind study
| Arm | Type | Receives |
|---|---|---|
| core decompression technique | Active comparator | Procedure: core decompressionThe standard surgical technique is the subchondral anterograde drilling, which permit a revascularization of the Bone Marrow Edema (BME) and a reduction of the intramedullary pressure (core decompression). |
| bone substitution (i-FactorTM) | Experimental | Biological: bone substitute i-FactorTMi-FactorTM is a combination of the mineral component of bone (Anorganic Bone Mineral) with a peptide replicating the cell-binding domain of Type-I collagen (P-15). It has been used in bone defects and in spine fusion providing good clinical results. Thus, i-FactorTM could be a valid and efficient bone substitute to treat BMLs with subchondral injections. |
| injections of autologous Bone Marrow Concentrate (BMC) | Experimental | Biological: autologous bone marrow concentrateinjections of autologous BMC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients between 18 and 75 years;
- Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
- Failure after at least two months of a conservative treatment;
- Single BME areas involving a single compartment of the knee;
- Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
Key exclusion criteria (11 listed)
- Patients incapable of discernment;
- History of allergy to calcium phosphates;
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
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 |
|---|---|---|
| autologous bone marrow concentrateinjection of autologous bone marrow concentrate | Biological | injections of autologous Bone Marrow Concentrate (BMC) |
| bone substitute i-FactorTMsubchondral injections of i-FactorTM | Biological | bone substitution (i-FactorTM) |
| core decompressionsubchondral anterograde drilling | Procedure or surgery | core decompression technique |
Primary outcome
change of Visual Analogue Scale (VAS) score
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in VAS score from baseline to follow up
3 secondary outcomes
International Knee Documentation Committee (IKDC) subjective score
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Knee Injury and Osteoarthritis Outcome (KOOS) Score
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Tegner Activity Level Scale
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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Focused Extracorporeal Shockwave Therapy for Knee Arthritis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing autologous bone marrow concentrate, bone substitute i-FactorTM and core decompression in people with Bone Marrow Edema, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 11 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: difficulty in recruiting). 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?
change of Visual Analogue Scale (VAS) score (time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]). 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 9 Aug 2018.