Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unicompartmental knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Unicompartmental Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
Overview
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.
Interventions
- Device Unicompartmental knee arthroplasty
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
Primary outcome measures
- Survival rate [Time frame: 5 years]
Secondary outcome measures (5)
- Survival rate [Time frame: 12-18 months to 10 years]
- Functional improvement [Time frame: From pre-operative to 10 years]
- Functional improvement [Time frame: From pre-operative to 10 years]
- Forgetfulness of prosthesis [Time frame: From pre-operative to 10 years]
- Activity [Time frame: From pre-operative to 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Lyon Sud — Pierre-Bénite
Identifiers
NCT: NCT05876143 · 2022-01