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

Unicompartmental Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876143
• Other study ID #: 2022-01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 31, 2035

Study information

• Verified date: May 2023
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: Clinical Department
• Phone: 0472056010
• Email: clinical[@]serf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 31, 2035
• Est. primary completion date: January 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Unicompartmental Knee Arthroplasty

Intervention

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 knee compared to the preoperative state.

Locations

Country	Name	City	State
France	CHU Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Assess the survival rate of the investigational medical devices at 5 year follow-up	5 years
Secondary	Survival rate	Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up	12-18 months to 10 years
Secondary	Functional improvement	Restoration of mobility and pain reduction evaluation using IKS score	From pre-operative to 10 years
Secondary	Functional improvement	Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score	From pre-operative to 10 years
Secondary	Forgetfulness of prosthesis	Evaluate the degree of forgetfulness of the prostheses using FJS- score	From pre-operative to 10 years
Secondary	Activity	Evaluate the degree of activity using Devane score	From pre-operative to 10 years