Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.

NCT06027697 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-09-07

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027697 on ClinicalTrials.gov