Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.
NCT06027697 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55
Last updated 2023-09-07
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 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.
Conditions
Interventions
- DEVICE
-
AccuFill® Porous Bone Substitute Material (BSM)
The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).
Sponsors & Collaborators
-
CEISO
collaborator INDUSTRY -
ClinServ
collaborator UNKNOWN -
Clinique Paris-Bercy
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2028-09-30
Countries
- France
Study Locations
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