Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.
ConditionKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClinique Paris-Bercy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Patients who go for a consultation for refractory mechanical knees pain
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AccuFill® Porous Bone Substitute Material (BSM)
DeviceThe patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Subchondroplasty1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Month 3Secondary outcomes
1
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).
Time frame
Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 482
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).
Time frame
Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 483
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.
Time frame
Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 484
Rate of adverse events
To assess the rate of adverse events
Time frame
Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: