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
Qualifiers
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 design
Treatments tested in this trial
- AccuFill® Porous Bone Substitute Material (BSM)
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov