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Recruiting NCT06592248

Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction (The Forgotten Knee)

No phase Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coc Knee.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction

Overview

The results of TKP (Total Knee Prosthesis) are satisfactory but do not reach those of THP (Total Hip Prosthesis) in terms of indolence and function. By using an all-ceramic friction torque, identical to that of the hip, the promotor of this Clinical Investigation expects to obtain an improvement in term of indolence, ability to perform heavy activities, knee stability and an improvement in the long-term survival of TKP, while at the same time, a decrease in the rate of re-intervention in young patients.

Detailed description

The aim of this study is to evaluate the all-ceramic knee prosthesis, according to clinical and radiological criteria of usual follow-up of a TKP for knee osteoarthritis, at 12 months.

Evaluation of clinical and radiographic endpoints at 12 months:

\- Clinical: functional scores (Oxford and International Knee Society IKS), pain (from 0 to 6, better to worse outcome), knee mobility in flexion and extension (degrees), frontal and sagittal stability (in degrees and mm), joint sounds, Forgotten Joint Score (FJS).

The scores are mostly qualitative and all of them will be globally evaluated by the investigator regarding to the patient status.

-Radiographic: X-rays of the front and profile of the prosthesis, positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element.

MRI will be performed to evaluate the creation of a specific fibrous tissue around the joint that is expected with a ceramic on ceramic bearing.

Interventions

  • Device Coc Knee
    Implementation of a ceramic on ceramic knee prosthesis

Primary outcome measures

  • Evaluation of clinical endpoint 1(Oxford score) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 2 (IKS score) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 3 (Forgotten Joint score) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 4 (Joint sounds) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 5 (Pain) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 6 (Knee mobility) at 12 months [Time frame: 1 year]
  • Evaluation of clinical endpoint 7 (Knee stability) at 12 months [Time frame: 1 year]
  • Evaluation of radiographic endpoints at 12 months [Time frame: 1 year]
Secondary outcome measures (10)
  • Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of clinical endpoint 7 (Knee stability) at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of radiographic endpoints at 3 and 6 months and physical capabilities of the patient [Time frame: 3 and 6 months]
  • Evaluation of fibrous tissue [Time frame: 1 year]
  • Validation of the ancillary equipment used and the prosthesis surgical technique [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Previously active adult under 70 years of age with disabling knee osteoarthritis resistant to medical treatments (anti-inflammatories, infiltrations, analgesics), with a frontal deformity < 10° for a primary implantation
  • Written informed consent by the patient
  • Patients affiliated to the French social security system

Exclusion criteria

  • Knee deformity > 10
  • Obesity (BMI > 30)
  • Inflammatory rheumatism
  • History of infection
  • Poor skin coverage at the knee joint
  • Known allergy to the materials used and/or anesthetic used in the surgery
  • Repeated falls, major neurological disorders, mental or neuromuscular disorders which can be a source of post-operative complications
  • Significant functional deficit of the collateral ligaments
  • Positive serum or urine pregnancy test for woman with child bearing potential. Pregnancy or within 48 hours post-partum or breast feeding women
  • Phobic patient refusing to have an MRI
  • Patient with a contraindication to have an MRI (active medical devices, metal implants, etc.)
  • Patient under legal protection
  • Patient participating in another Clinical Investigation
  • Post fracture osteoarthritis
  • Osteoporosis
  • Anatomical configuration not allowing the implant to be fixed (depending on size constraints)
  • Disabling comorbidity upon any resumption of physical activity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpital Lariboisière — Paris

Identifiers

NCT: NCT06592248 · APHP190284 · 2020-A02892-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗