Unicompartmental Knee ArthroplastyNCT05876143
Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants
An observational study of Unicompartmental Knee Arthroplasty, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unicompartmental Knee Arthroplasty
- What is being tested?
- Unicompartmental knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 31 Jan 2035
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed 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.
- Conditions
- Unicompartmental Knee Arthroplasty
- Being tested
- Unicompartmental knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental knee arthroplastyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed cementless UKP | Patient implanted with a fixed cementless Unicompartmental prosthesis Receives: Device: Unicompartmental knee arthroplasty | |
| Fixed cemented UKP | Patient implanted with a fixed cemented Unicompartmental prosthesis Receives: Device: Unicompartmental knee arthroplasty | |
| Mobile Cementless UKP | Patient implanted with a mobile cementless Unicompartmental prosthesis Receives: Device: Unicompartmental knee arthroplasty | |
| Mobile Cemented UKP | Patient implanted with a mobile cemented Unicompartmental prosthesis Receives: Device: Unicompartmental knee arthroplasty | |
| Fixed Cementless UKP (TIT coating) | Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT" Receives: Device: Unicompartmental knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Assess the survival rate of the investigational medical devices at 5 year follow-up
Measured: 5 years
Secondary outcomes (5)
Survival rate
Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up
Measured: 12-18 months to 10 years
Functional improvement
Restoration of mobility and pain reduction evaluation using IKS score
Measured: From pre-operative to 10 years
Functional improvement
Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score
Measured: From pre-operative to 10 years
Forgetfulness of prosthesis
Evaluate the degree of forgetfulness of the prostheses using FJS- score
Measured: From pre-operative to 10 years
Activity
Evaluate the degree of activity using Devane score
Measured: From pre-operative to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jan 2023
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unicompartmental Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876143
- Sponsor's protocol ID
- 2022-01
- Status last verified
- Apr 2026
- First submitted
- 16 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
- ClinicalTrials.gov ID
- NCT05876143
- Acronym / sponsor ID
- 2022-01
- Conditions
- Unicompartmental Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fixed cementless UKP | – | Device: Unicompartmental knee arthroplastyPatient implanted with a fixed cementless Unicompartmental prosthesis |
| Fixed cemented UKP | – | Device: Unicompartmental knee arthroplastyPatient implanted with a fixed cemented Unicompartmental prosthesis |
| Mobile Cementless UKP | – | Device: Unicompartmental knee arthroplastyPatient implanted with a mobile cementless Unicompartmental prosthesis |
| Mobile Cemented UKP | – | Device: Unicompartmental knee arthroplastyPatient implanted with a mobile cemented Unicompartmental prosthesis |
| Fixed Cementless UKP (TIT coating) | – | Device: Unicompartmental knee arthroplastyPatient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (1 listed)
- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unicompartmental knee arthroplastyKnee 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. | Device | Fixed Cementless UKP (TIT coating), Fixed cemented UKP, Fixed cementless UKP, Mobile Cemented UKP, Mobile Cementless UKP |
Primary outcome
Survival rate
Time frame: 5 years
Assess the survival rate of the investigational medical devices at 5 year follow-up
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unicompartmental Knee Arthroplasty, run by Societe dEtude, de Recherche et de Fabrication 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 1 inclusion and 3 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 22 Apr 2026. 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 Clinical Department (0472056010 ext. +33, clinical@serf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.