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NCT Number: NCT05876143

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

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.

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Key information

Conditions

Unicompartmental Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lyon Sud

Pierre-Bénite, France

Location status: Recruiting

Location contact

Anthony Viste

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Survival rate

    Time frame: 5 years

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

Secondary outcomes

  1. Survival rate

    Time frame: 12-18 months to 10 years

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

  2. Functional improvement

    Time frame: From pre-operative to 10 years

    Restoration of mobility and pain reduction evaluation using IKS score

  3. Functional improvement

    Time frame: From pre-operative to 10 years

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

  4. Forgetfulness of prosthesis

    Time frame: From pre-operative to 10 years

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

  5. Activity

    Time frame: From pre-operative to 10 years

    Evaluate the degree of activity using Devane score

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Department

CONTACT

[email protected]

0472056010 ext. +33

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Official study title

Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants

Important dates

Study start
2023
Primary completion
2030
Study completion
2035
First posted
May 25, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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