NCT06027697

Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Clinique Paris-Bercy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2028-09-01
• First posted: 2023-09-07
• Last updated: 2023-09-07

Locations

1 site across 1 country: France