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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Coc Knee

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal BIZOT, MD, Pr; Phone Number: +33 (0)1 49 95 91 34; Email: pascal.bizot@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hopital Lariboisière
    • Contact: Pascal BIZOT, MD, Pr; Phone Number: +33 1 49 95 91 34; Email: pascal.bizot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CocKnee; Implementation of CocKnee	Device: Coc Knee; Implementation of a ceramic on ceramic knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 pointssatisfaction 40 pointsfunction 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient	Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort )	3 and 6 months
Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient	Clinical 2 : International Knee Society (IKS) score : objective component (symptoms) 25 points; subjective component:expectation (pre or post surgery) 15 pointssatisfaction 40 pointsfunction 100 points	3 and 6 months
Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient	Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25)	3 and 6 months
Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient	Clinical 4 : Joint sounds : 5 questions, no score	3 and 6 months
Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient	Clinical 5 : Pain : 0 to 6	3 and 6 months
Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient	Clinical 6 : Knee mobility : Flexion (°) Extension (°)	3 and 6 months
Evaluation of clinical endpoint 7 (Knee stability) at 3 and 6 months and physical capabilities of the patient	Clinical 7 : Knee stability : Frontal (° and mm) Sagittal (° and mm)	3 and 6 months
Evaluation of radiographic endpoints at 3 and 6 months and physical capabilities of the patient	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.	3 and 6 months
Evaluation of fibrous tissue	Evaluation of fibrous tissue around the prosthesis: Performance of ultrasounds and MRI at 3, 6 and 12 months postoperatively, allowing to evaluate and measure (in mm) the thickness and progression of fibrous tissue around the prosthesis.	1 year
Validation of the ancillary equipment used and the prosthesis surgical technique	Notification of any malfunction noticed during the use of ancillary equipment	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pascal BIZOT, MD, Pr, APHP; Study Director: Laurent SEDEL, MD, Pr, CC/ Contact

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): December 19, 2025
• Study Completion (Estimated): December 19, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Total Knee Prosthesis; Ceramic on ceramic bearing
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: APHP190284; 2020-A02892-37 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No