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

NCT06592248 | Recruiting DMC

• 2 other identifiers: APHP1902842020-A02892-37
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Prosthesis; Ceramic on ceramic bearing

Outcome Measures

Primary Outcomes (8)

• Evaluation of clinical endpoint 1(Oxford score) at 12 months

  Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort )

  1 year

• Evaluation of clinical endpoint 2 (IKS score) at 12 months

  Clinical 2 : International Knee Society (IKS) score : * objective component (symptoms) 25 points * subjective component: * expectation (pre or post surgery) 15 points * satisfaction 40 points * function 100 points

  1 year

• Evaluation of clinical endpoint 3 (Forgotten Joint score) at 12 months

  Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25)

  1 year

• Evaluation of clinical endpoint 4 (Joint sounds) at 12 months

  Clinical 4: Joint sounds : 5 questions, no score

  1 year

• Evaluation of clinical endpoint 5 (Pain) at 12 months

  Clinical 5: Pain : 0 to 6

  1 year

• Evaluation of clinical endpoint 6 (Knee mobility) at 12 months

  Clinical 6: Knee mobility : Flexion (°) Extension (°)

  1 year

• Evaluation of clinical endpoint 7 (Knee stability) at 12 months

  Clinical 7: Knee stability : Frontal (° and mm) Sagittal (° and mm)

  1 year

• Evaluation of radiographic endpoints at 12 months

  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.

  1 year

Secondary Outcomes (10)

• Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient

  3 and 6 months

• Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient

  3 and 6 months

• Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient

  3 and 6 months

• Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient

  3 and 6 months

• Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient

  3 and 6 months

Study Arms (1)

CocKnee

EXPERIMENTAL

Implementation of CocKnee

Device: Coc Knee

Interventions

Coc Knee DEVICE

Implementation of a ceramic on ceramic knee prosthesis

CocKnee

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Pascal BIZOT, MD, Pr

  APHP

  PRINCIPAL INVESTIGATOR

• Laurent SEDEL, MD, Pr

  CC/ Contact

  STUDY DIRECTOR

Central Study Contacts

Pascal BIZOT, MD, Pr

CONTACT

+33 (0)1 49 95 91 34; pascal.bizot@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Validation of the concept * Absence of added risks after implementation * Measurement of fibrous tissue formed by MRI examination Inclusion will be done by sequencing in 2 steps: * Inclusion of 2 patients with implementation of the experimental MD with a post-operative follow-up of 3 months, * if no SAE linked to the experimental MD is detected, the inclusions will continue until the 5th patient with experimental DM, * In the event of notification of an SAE linked to the experimental MD according to the investigator in the first 2 patients, within the first 3 months, the research will be stopped prematurely

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2024
• Primary Completion: December 19, 2025
• Study Completion (Estimated): December 19, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)