Bone Marrow EdemaNCT04905394
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
A study testing subchondroplasty in people with Bone Marrow Edema, run by University of Milan at 1 site in Italy.
Trial summary
Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- subchondroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 30 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atraumatic knee pain for at least 3 months;
- Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
- Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
- BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)
Who cannot join
- Knee pain and functional limitation related to other causes like osteonecrosis
- Fractures or inflammatory arthritis
- Ligamentous instabilities
- Malalignment on the coronal axis greater than 10 degrees in varus/valgus
- Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.
- Conditions
- Bone Marrow Edema
- Being tested
- subchondroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subchondroplastyProcedure or surgery
subchondroplasty is an innovative percutaneous procedure in which calcium phosphate, biocompatible material similar to the native bone apatite with osteoinductive properties, is injected inside BML areas. The purpose of subchondroplasty is the patient's symptoms relief, improving the mechanical strength of subchondral bone, stimulating bone remodeling to avoid bone sagging, and slow down the arthritic degenerative process to postpone arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with subchondroplasty for bone edema in the knee | Experimental | Patients treated with subchondroplasty for bone edema of the knee Receives: Procedure: subchondroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain reduction of 4 points in numeric rating score
Measured: 6 months
Secondary outcomes (1)
Radiological evaluation
Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren\&Lawrence classification
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 posted27 May 2021
- Study start1 Apr 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2021
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 Bone Marrow EdemaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
- Investigators
- pietro randelli, prof, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905394
- Sponsor's protocol ID
- SubCond
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researcher will not share data with other organizations
Publications
Randelli P, Compagnoni R, Ferrua P, Ricci M, La Verde L, Mekky AF, De Silvestri A, Menon A. Efficacy of Subchondroplasty in the Treatment of Pain Associated With Bone Marrow Lesions in the Osteoarthritic Knee. Orthop J Sports Med. 2023 May 16;11(5):23259671231163528. doi: 10.1177/23259671231163528. eCollection 2023 May.
PubMed 37213661
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
- ClinicalTrials.gov ID
- NCT04905394
- Acronym / sponsor ID
- SubCond
- Conditions
- Bone Marrow Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 27 May 2021 (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.
Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with subchondroplasty for bone edema in the knee | Experimental | Procedure: subchondroplastyPatients treated with subchondroplasty for bone edema of the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Atraumatic knee pain for at least 3 months;
- Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
- Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
- BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)
Key exclusion criteria (5 listed)
- Knee pain and functional limitation related to other causes like osteonecrosis
- Fractures or inflammatory arthritis
- Ligamentous instabilities
- Malalignment on the coronal axis greater than 10 degrees in varus/valgus
- Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)
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 |
|---|---|---|
| subchondroplastysubchondroplasty is an innovative percutaneous procedure in which calcium phosphate, biocompatible material similar to the native bone apatite with osteoinductive properties, is injected inside BML areas. The purpose of subchondroplasty is the patient's symptoms relief, improving the mechanical strength of subchondral bone, stimulating bone remodeling to avoid bone sagging, and slow down the arthritic degenerative process to postpone arthroplasty. | Procedure or surgery | Treatment with subchondroplasty for bone edema in the knee |
Primary outcome
Pain reduction
Time frame: 6 months
Pain reduction of 4 points in numeric rating score
1 secondary outcome
Radiological evaluation
Time frame: 6 months
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 27 May 2021.
- Derived from this study: PubMed 37213661Randelli P, Compagnoni R, Ferrua P, Ricci M, La Verde L, Mekky AF, De Silvestri A, Menon A. Efficacy of Subchondroplasty in the Treatment of Pain Associated With Bone Marrow Lesions in the Osteoarthritic Knee. Orthop J Sports Med. 2023 May 16;11(5):23259671231163528. doi: 10.1177/23259671231163528. eCollection 2023 May.
- Individual participant dataSharing planned: No. Researcher will not share data with other organizations
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Recruiting
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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.
pietro randelli, prof principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subchondroplasty in people with Bone Marrow Edema, run by University of Milan 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 4 inclusion and 5 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 27 May 2021. 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.
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?
Pain reduction (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 NCT04905394, 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 27 May 2021.