Prospective Evaluation of Subchondroplasty in Advanced Knee

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06027697
Study type	Observational
Source	Clinique Paris-Bercy
Contact	Guy Mylle, Dr
Phone	01 44 01 01 02
Email	guymylle@gmail.com
Status	Not yet recruiting
Phase
Start date	December 2023
Completion date	September 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms