Knee OsteoarthritisNCT06027697
Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.
An observational study of Knee Osteoarthritis, run by Clinique Paris-Bercy at 1 site in France.
Trial summary
The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis. The main question it aims to answer is: Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AccuFill® Porous Bone Substitute Material (BSM)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2023to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who go for a consultation for refractory mechanical knees pain
Who may be able to join
- Patient 18 years of age or older;
- Patient with a Body Mass Index ≤35 (BMI=kg/m2);
- Patient with Kellgren-Lawrence grade 3-4 Osteoarthritis, as reviewed on MRI and plain radiography;
- Patient with knee bone marrow lesions confirmed by MRI result at least 3 months before the intervention;
- Patients with degenerative knee pathology at the prosthetic stage (outdated medical treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay the prosthetic procedure as much as possible) / goniometry);
- Patient with unbearable mechanical pain with a walking perimeter limited at 500 m
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- Patient with non-surgical treatment failure (infiltration of Platelet Rich Plasma (PRP), corticoids, acid hyaluronic);
- Patient who agrees to participate in the study and who signed the informed non-opposition form;
- Patient physically and mentally willing and able, in the Investigator's opinion at the time of enrolment, to be compliant with the protocol including all follow-up visits, survey completion, weight- bearing restrictions, and post-operative rehabilitation;
- Patient with social protection.
Who cannot join
- Patient with a Body Mass Index > 35 (BMI=kg/m2);
- Patient with inflammatory rheumatic pathologies;
- Patient with frontal deformities (varus, valgus) of more than 12°;
- Patient with degenerative pathologies at the operative stage but likely to benefit from a conservative intervention (osteotomy), except if the knee is centred;
- Patient with stiff knees (more than 20° of flexum and/or less than 90° of flexion);
- Patient with painful severe femoro-patellar osteoarthritis;
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- Patient with contraindications for Magnetic Resonance Imaging (MRI);
- Patient with history of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease);
- Patient with history of cognitive-behavioural disorders that could interact with assessment by self-questionnaire;
- Patient with local or general infection or suspicion of infection;
- Patient with severe coagulation disorders;
- Patient with primary bone tumour in the knee area,
- Patient with undercurrent serious pathology with life expectance < 2 years;
- Female patient of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
- Patient who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection;
- Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study;
- Patients who cannot read or write French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis.
The main question it aims to answer is:
- Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ?
Participants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement.
This study will be conducted for 4 years.
Read the detailed description
Background :
The technique of subchondroplasty is recent and was created to follow the availability of low-viscosity injectable phosphocalcic cement. It is aimed at osteoarthritic lesions and proposes to treat subchondral disease associated with the process of osteoarthritic degeneration, and which would be particularly painful in the support area.
This technique seems interesting in terms of effectiveness with less risk since it is a minimally invasive percutaneous procedure and it is systematically practiced on an outpatient basis.
In this context, the principal investigator has decided to conduct a long-term study for the first time in France in order to collect clinical data and data on the safety profile of the device.
Design :
This study is prospective, longitudinal, observational, single-arm, open monocentric and is a post-market study.
Intervention :
As the current study is observational, the study will follow the usual standard of care.
The participation of the patient can be divided in 2 parts :
- The first part is the treatment. After the inclusion of the patient, this latest will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the treatment (AccuFill Porous Bone Substitute Material (BSM)).
- The second part is the follow-up visits. During this part the patient will follow a appointment schedule with the doctor in order for the physicien to realised a clinical examination and for the patient to fulfil the 3 validated questionnaires. These visits will be spaced out over 4 years.
- Conditions
- Knee Osteoarthritis
- Being tested
- AccuFill® Porous Bone Substitute Material (BSM)
- Keywords
- Knee osteoarthritis, Subchondroplasty, Knee mechanical pain, AccuFill Porous Bone Substitute Material, Minimally invasive surgical procedure
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuFill® Porous Bone Substitute Material (BSM)Device
Also called Subchondroplasty
The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).
| Study group | Role | What they receive |
|---|---|---|
| Subchondroplasty | AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit).
During the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement. Receives: Device: AccuFill® Porous Bone Substitute Material (BSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months.
Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)
Measured: Month 3
Secondary outcomes (6)
Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to each visits
Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10).
Measured: Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48
Change from baseline (inclusion) in International Knee Documentation Committee (IKDC) score to each visits
IKDC is a subjective knee evaluation form to detect improvement or deterioration in symptoms, function and sports activities due to knee impairment.
This self-questionnaire is divided into three parts (symptoms, sports activities, function) and gives a score between 0 (worst) and 100 (best).
Measured: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Change from baseline (inclusion) for the Knee injury and Osteoarthritis Outcome Score (KOOS) to each visits
KOOS is a knee-specific instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.
It contains 42 items divided into five subscales:
KOOS Pain, KOOS Symptoms, Activities of Daily Living (KOOS ADL), Sport (KOOS Sport), and Quality of Life regarding the knee (KOOS QOL). Total scores can range from 0 to 100.
Measured: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Rate of adverse events
To assess the rate of adverse events
Measured: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Radiography and MRI evolution of the knee lesions from baseline (inclusion) to 24 months
Morphologic evolution of knee joint on MRI and radiography
Measured: Month 24
Rate of conversion to prosthetic replacement
Rate of patient who have to undergo to prosthetic replacement
Measured: Month 12, Month 24, Month 36, Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Paris-Bercy
- Sponsor type
- University, hospital or other
- Collaborators
- CEISO, ClinServ
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027697
- Sponsor's protocol ID
- Subchondroplasty
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06027697
- Acronym / sponsor ID
- Subchondroplasty
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Subchondroplasty, Knee mechanical pain, AccuFill Porous Bone Substitute Material, Minimally invasive surgical procedure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Clinique Paris-BercyUniversity, hospital or other
- Collaborators
- CEISO, ClinServ
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Sep 2023 (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.
The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis.
The main question it aims to answer is:
- Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ?
Participants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement.
This study will be conducted for 4 years.
Detailed description
Background :
The technique of subchondroplasty is recent and was created to follow the availability of low-viscosity injectable phosphocalcic cement. It is aimed at osteoarthritic lesions and proposes to treat subchondral disease associated with the process of osteoarthritic degeneration, and which would be particularly painful in the support area.
This technique seems interesting in terms of effectiveness with less risk since it is a minimally invasive percutaneous procedure and it is systematically practiced on an outpatient basis.
In this context, the principal investigator has decided to conduct a long-term study for the first time in France in order to collect clinical data and data on the safety profile of the device.
Design :
This study is prospective, longitudinal, observational, single-arm, open monocentric and is a post-market study.
Intervention :
As the current study is observational, the study will follow the usual standard of care.
The participation of the patient can be divided in 2 parts :
- The first part is the treatment. After the inclusion of the patient, this latest will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the treatment (AccuFill Porous Bone Substitute Material (BSM)).
- The second part is the follow-up visits. During this part the patient will follow a appointment schedule with the doctor in order for the physicien to realised a clinical examination and for the patient to fulfil the 3 validated questionnaires. These visits will be spaced out over 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subchondroplasty | – | Device: AccuFill® Porous Bone Substitute Material (BSM)AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit). During the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who go for a consultation for refractory mechanical knees pain
Key inclusion criteria (10 listed)
- Patient 18 years of age or older;
- Patient with a Body Mass Index ≤35 (BMI=kg/m2);
- Patient with Kellgren-Lawrence grade 3-4 Osteoarthritis, as reviewed on MRI and plain radiography;
- Patient with knee bone marrow lesions confirmed by MRI result at least 3 months before the intervention;
- Patients with degenerative knee pathology at the prosthetic stage (outdated medical treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay the prosthetic procedure as much as possible) / goniometry);
Key exclusion criteria (17 listed)
- Patient with a Body Mass Index > 35 (BMI=kg/m2);
- Patient with inflammatory rheumatic pathologies;
- Patient with frontal deformities (varus, valgus) of more than 12°;
- Patient with degenerative pathologies at the operative stage but likely to benefit from a conservative intervention (osteotomy), except if the knee is centred;
- Patient with stiff knees (more than 20° of flexum and/or less than 90° of flexion);
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 |
|---|---|---|
| AccuFill® Porous Bone Substitute Material (BSM)Also: SubchondroplastyThe patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM). | Device | Subchondroplasty |
Primary outcome
Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months.
Time frame: Month 3
Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)
6 secondary outcomes
Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to each visits
Time frame: Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48
Change from baseline (inclusion) in International Knee Documentation Committee (IKDC) score to each visits
Time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Change from baseline (inclusion) for the Knee injury and Osteoarthritis Outcome Score (KOOS) to each visits
Time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Rate of adverse events
Time frame: Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48
Radiography and MRI evolution of the knee lesions from baseline (inclusion) to 24 months
Time frame: Month 24
Rate of conversion to prosthetic replacement
Time frame: Month 12, Month 24, Month 36, Month 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Clinique Paris-Bercy at 1 site in France.
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 10 inclusion and 17 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: opening soon, as of the sponsor's last update on 7 Sep 2023. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guy Mylle, Dr (01 44 01 01 02, guymylle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months. (time frame: Month 3). 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 7 Sep 2023.