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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
| ClinServ | UNKNOWN |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuFill® Porous Bone Substitute Material (BSM) | Device | The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who go for a consultation for refractory mechanical knees pain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guy Mylle, Dr | Contact | 01 44 01 01 02 | guymylle@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Paris Bercy | Charenton-le-Pont | 94220 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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). | 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. | 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 | 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 | Month 24 |
| Rate of conversion to prosthetic replacement | Rate of patient who have to undergo to prosthetic replacement | Month 12, Month 24, Month 36, Month 48 |
| D012216 |
| Rheumatic Diseases |