Knee ArthropathyTKA&RTSNCT05928403
Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Types of Prostheses
An observational study of Knee Arthropathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- total knee prosthesis
- How many people
- 660 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jun 2024to Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are eligible on retrospective criteria. These are patients who underwent total knee prosthesis surgery between 2018 and 2020 with placement of a medial pivot, medial bearing and cruciate retaining type prosthesis.
Who may be able to join
- First total knee prosthesis between 2018 and 2020;
- Conventional alignment technique using the same surgical technique for total knee prosthesis;
- Placement of a medial pivot prosthesis (Evolution®), mobile bearing (SCORE® Amplitude) or traditional cruciate retaining prosthesis (Stryker® Triathlon);
- Affiliation to a social security scheme;
- Patient having been informed and having given his oral non-objection
Who cannot join
- Bilateral total knee prosthesis;
- Medical history of revision of Total Knee Prosthesis;
- Articulation malformation of the lower limbs;
- Having undergone revision surgery;
- Inability to understand information related to the study for linguistic, psychological, cognitive reasons;
- Patient under legal protection, or deprived of liberty by judicial or administrative decision.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Clinique Aguiléra
Biarritz, 64200
Jérôme MURGIER, MD, 5 36 28 64 00 ext. +33, murgier.jerome@hotmail.fr
- Recruiting
Clinique des Cèdres
Cornebarrieu, 31700
Xavier CASSARD, MD, 562133284 ext. +33, dr.cassard@orange.fr
About this study
Official title: Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Different Types of Prostheses (Medial Pivot, Medial Bearing and Cruciate Retaining)
The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.
Read the detailed description
This is an ambispective, comparative study of three cohorts, non-randomized, open, monocentric, relating to the return to sport of patients who have benefited from one of the three designs of prostheses under study (medial pivot, medial bearing and cruciate retaining) after total knee prosthesis.
Patients who received a total knee prosthesis with medial pivot, medial bearing and cruciate retaining prosthesis between 2018 and 2020 will be called by the investigator, and the study will be offered to them (D-3 to D0). The investigator will explain the study to the patient, send him the information note electronically and answer all his questions about the study. If the patient agrees to participate after a reflection period, the inclusion (D0) will be documented in the medical file, and the patient will be assessed the same day by telephone using the assessments set up in the study, except for the questionnaires on his functional and physical abilities that will be sent to him electronically. The patient will return his answers to the questionnaires on this same email address or by telephone according to his preference. A secure and unique email address will be created by the principal investigator for the purposes of the study and for use strictly specific to the study, in the investigating center.
- Conditions
- Knee Arthropathy
- Being tested
- total knee prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee prosthesisOther
Comparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis
| Study group | Role | What they receive |
|---|---|---|
| medial pivot | Return to sport rate for patients with a Medial Pivot knee prosthesis Receives: Other: total knee prosthesis | |
| medial bearing | Return to sport rate for patients with a Medial Bearing knee prosthesis Receives: Other: total knee prosthesis | |
| cruciate retaining | Return to sport rate for patients with a Cruciate Retaining prosthesis Receives: Other: total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of return to sport
rate of return to sport after a minimum of 3 years after total knee prosthesis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928403
- Sponsor's protocol ID
- 2023-A00626-39
- Acronym
- TKA&RTS
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Different Types of Prostheses (Medial Pivot, Medial Bearing and Cruciate Retaining)
- ClinicalTrials.gov ID
- NCT05928403
- Acronym / sponsor ID
- TKA&RTS / 2023-A00626-39
- Conditions
- Knee Arthropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jul 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.
The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.
Detailed description
This is an ambispective, comparative study of three cohorts, non-randomized, open, monocentric, relating to the return to sport of patients who have benefited from one of the three designs of prostheses under study (medial pivot, medial bearing and cruciate retaining) after total knee prosthesis.
Patients who received a total knee prosthesis with medial pivot, medial bearing and cruciate retaining prosthesis between 2018 and 2020 will be called by the investigator, and the study will be offered to them (D-3 to D0). The investigator will explain the study to the patient, send him the information note electronically and answer all his questions about the study. If the patient agrees to participate after a reflection period, the inclusion (D0) will be documented in the medical file, and the patient will be assessed the same day by telephone using the assessments set up in the study, except for the questionnaires on his functional and physical abilities that will be sent to him electronically. The patient will return his answers to the questionnaires on this same email address or by telephone according to his preference. A secure and unique email address will be created by the principal investigator for the purposes of the study and for use strictly specific to the study, in the investigating center.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medial pivot | – | Other: total knee prosthesisReturn to sport rate for patients with a Medial Pivot knee prosthesis |
| medial bearing | – | Other: total knee prosthesisReturn to sport rate for patients with a Medial Bearing knee prosthesis |
| cruciate retaining | – | Other: total knee prosthesisReturn to sport rate for patients with a Cruciate Retaining prosthesis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible on retrospective criteria. These are patients who underwent total knee prosthesis surgery between 2018 and 2020 with placement of a medial pivot, medial bearing and cruciate retaining type prosthesis.
Key inclusion criteria (5 listed)
- First total knee prosthesis between 2018 and 2020;
- Conventional alignment technique using the same surgical technique for total knee prosthesis;
- Placement of a medial pivot prosthesis (Evolution®), mobile bearing (SCORE® Amplitude) or traditional cruciate retaining prosthesis (Stryker® Triathlon);
- Affiliation to a social security scheme;
- Patient having been informed and having given his oral non-objection
Key exclusion criteria (6 listed)
- Bilateral total knee prosthesis;
- Medical history of revision of Total Knee Prosthesis;
- Articulation malformation of the lower limbs;
- Having undergone revision surgery;
- Inability to understand information related to the study for linguistic, psychological, cognitive reasons;
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 |
|---|---|---|
| total knee prosthesisComparison of three cohorts on the return to sport of patients after total knee prosthesis according to the type of prosthesis | Other | cruciate retaining, medial bearing, medial pivot |
Primary outcome
rate of return to sport
Time frame: 3 years
rate of return to sport after a minimum of 3 years after total knee prosthesis
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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites 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 5 inclusion and 6 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of return to sport (time frame: 3 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 15 Jan 2026.