Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication

About this trial

This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients who objected to participating in the study and the processing of their data

Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up

Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.

Trial population

Male or female adult for whom a unicondylar knee prosthesis is indicated according to U-Knee / Uni-Kroma instructions for use. Patients will be followed according to current practice

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Unicompartmental knee arthroplasty

    Device

    Knee joint could be subject to natural or pathological wear or shocks (primary or secondary evolutive or traumatic osteoarthritis) which cause pain and reduced mobility of the knee. When only one lateral or medial compartment of the femoro-tibial knee joint is affected, the treatment of unicompartmental femoro-tibial osteoarthritis of the knee is generally carried out by the implantation of a so-called unicondylar knee prosthesis (UKP), in order to reduce pain and improve joint mobility of the knee compared to the preoperative state.

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: Fixed cementless UKP1 intervention
Group B: Fixed cemented UKP1 intervention
Group C: Mobile Cementless UKP1 intervention
Group D: Mobile Cemented UKP1 intervention
Group E: Fixed Cementless UKP (TIT coating)1 intervention

Trial outcomes

Primary outcomes

1

Survival rate

Assess the survival rate of the investigational medical devices at 5 year follow-up

Time frame
5 years

Secondary outcomes

1

Survival rate

Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up

Time frame
12-18 months to 10 years
2

Functional improvement

Restoration of mobility and pain reduction evaluation using IKS score

Time frame
From pre-operative to 10 years
3

Functional improvement

Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score

Time frame
From pre-operative to 10 years
4

Forgetfulness of prosthesis

Evaluate the degree of forgetfulness of the prostheses using FJS- score

Time frame
From pre-operative to 10 years

Other outcomes

Sponsors and contacts

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