Status:
NOT_YET_RECRUITING
Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.
Lead Sponsor:
Clinique Paris-Bercy
Collaborating Sponsors:
CEISO
ClinServ
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Brief 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 subchondroplas...
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 propose...
Eligibility Criteria
Inclusion
- 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;
- Patients with degenerative knee pathology at the prosthetic stage (outdated medical treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay the prosthetic procedure as much as possible) / goniometry);
- Patient with unbearable mechanical pain with a walking perimeter limited at 500 m
- Patient with non-surgical treatment failure (infiltration of Platelet Rich Plasma (PRP), corticoids, acid hyaluronic);
- Patient who agrees to participate in the study and who signed the informed non-opposition form;
- Patient physically and mentally willing and able, in the Investigator's opinion at the time of enrolment, to be compliant with the protocol including all follow-up visits, survey completion, weight- bearing restrictions, and post-operative rehabilitation;
- Patient with social protection.
Exclusion
- 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;
- Patient with stiff knees (more than 20° of flexum and/or less than 90° of flexion);
- Patient with painful severe femoro-patellar osteoarthritis;
- Patient with contraindications for Magnetic Resonance Imaging (MRI);
- Patient with history of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease);
- Patient with history of cognitive-behavioural disorders that could interact with assessment by self-questionnaire;
- Patient with local or general infection or suspicion of infection;
- Patient with severe coagulation disorders;
- Patient with primary bone tumour in the knee area,
- Patient with undercurrent serious pathology with life expectance \< 2 years;
- Female patient of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
- Patient who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection;
- Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study;
- Patients who cannot read or write French
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06027697
Start Date
December 1 2023
End Date
September 1 2028
Last Update
September 7 2023
Active Locations (1)
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1
Clinique Paris Bercy
Charenton-le-Pont, France, 94220