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Knee OsteoarthritisForgottenKneNCT06592248

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

A study testing Coc Knee in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Coc Knee
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteFrance
Study dates
19 Dec 2024to 19 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pascal BIZOT, MD, Pr contact

+33 (0)1 49 95 91 34

pascal.bizot@aphp.fr

France1 site, 1 recruiting

  • Hôpital Lariboisière

    Paris, 75010

    Pascal BIZOT, MD, Pr, +33 1 49 95 91 34, pascal.bizot@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Coc Knee
Keywords
Total Knee Prosthesis, Ceramic on ceramic bearing
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coc KneeDevice

    Implementation of a ceramic on ceramic knee prosthesis

Study groups in NCT06592248
Study groupRoleWhat they receive
CocKneeExperimentalImplementation of CocKnee
Receives: Device: Coc Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 )

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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)

    Measured: 1 year

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

    Clinical 4:

    Joint sounds :

    5 questions, no score

    Measured: 1 year

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

    Clinical 5:

    Pain : 0 to 6

    Measured: 1 year

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

    Clinical 6:

    Knee mobility :

    Flexion (°) Extension (°)

    Measured: 1 year

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

    Clinical 7:

    Knee stability :

    Frontal (° and mm) Sagittal (° and mm)

    Measured: 1 year

  8. 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.

    Measured: 1 year

Secondary outcomes (10)

  1. 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 )

    Measured: 3 and 6 months

  2. 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 points
    • satisfaction 40 points
    • function 100 points

    Measured: 3 and 6 months

  3. 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)

    Measured: 3 and 6 months

  4. 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

    Measured: 3 and 6 months

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

    Clinical 5 :

    Pain : 0 to 6

    Measured: 3 and 6 months

  6. Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient

    Clinical 6 :

    Knee mobility :

    Flexion (°) Extension (°)

    Measured: 3 and 6 months

  7. 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)

    Measured: 3 and 6 months

  8. 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.

    Measured: 3 and 6 months

  9. 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.

    Measured: 1 year

  10. Validation of the ancillary equipment used and the prosthesis surgical technique

    Notification of any malfunction noticed during the use of ancillary equipment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start19 Dec 2024
  3. Primary completion19 Dec 2025 (estimated)
  4. Study completion19 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
* 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
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592248
Sponsor's protocol ID
APHP190284
Other IDs
2020-A02892-37
Acronym
ForgottenKne
Status last verified
Jan 2025
First submitted
16 Jul 2024
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Coc Knee in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pascal BIZOT, MD, Pr (+33 (0)1 49 95 91 34, pascal.bizot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of clinical endpoint 1(Oxford score) at 12 months (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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