Knee ArthritisNCT00435357
Comparison Between Fixed- Versus Mobile-bearing TKA
A study testing mobile-bearing TKA and fixed- bearing TKA in people with Knee Arthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- mobile-bearing TKA and fixed- bearing TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medial medial femorotibial arthritis requiring an arthroplasty
- Age between 50y and 90y
Who cannot join
- Lateral femorotibial arthritis
- Inflammatory disease
- Stiff knee with flexion under 90°
- Revision TKA
- Previous surgery (except meniscectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study
The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.
- Conditions
- Knee Arthritis
- Being tested
- mobile-bearing TKA, fixed- bearing TKA
- Keywords
- Mobile-bearing, arthroplasty, fixed-bearing, knee, patella, posterior stabilized TKA
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-bearing TKADevice
fixed- bearing TKADevice
| Study group | Role | What they receive |
|---|---|---|
| mobile-bearing TKA | Experimental | Not described Receives: Device: mobile-bearing TKA |
| fixed- bearing TKA | Active comparator | Not described Receives: Device: fixed- bearing TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Society Score
Measured: 2, 6 and 12 monthes after surgery
Secondary outcomes (3)
Patellofemoral tilt on skyline view, measurement of two angles :
Measured: 2 and 12 monthes after surgery
patellar tilt
Measured: 2 and 12 monthes after surgery
patellar displacement from the center of the trochlear groove
Measured: 2 and 12 monthes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Neyret, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435357
- Sponsor's protocol ID
- 2005.407
- Status last verified
- May 2026
- First submitted
- 13 Feb 2007
- Last updated
- 15 May 2026
- Results posted
- No
Publications
Sappey-Marinier E, Swan J, Maucort-Boulch D, Batailler C, Malatray M, Neyret P, Lustig S, Servien E. No significant clinical and radiological differences between fixed versus mobile bearing total knee replacement using the same semi-constrained implant type: a randomized controlled trial with mean 10 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):603-611. doi: 10.1007/s00167-020-06346-1. Epub 2020 Nov 5.
PubMed 33151364Sappey-Marinier E, de Abreu FGA, O'Loughlin P, Gaillard R, Neyret P, Lustig S, Servien E. No difference in patellar position between mobile-bearing and fixed-bearing total knee arthroplasty for medial osteoarthritis: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 2020 May;28(5):1542-1550. doi: 10.1007/s00167-019-05565-5. Epub 2019 Jun 19.
PubMed 31218390
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00435357
- Acronym / sponsor ID
- 2005.407
- Conditions
- Knee Arthritis
- Keywords
- Mobile-bearing, arthroplasty, fixed-bearing, knee, patella, posterior stabilized TKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Feb 2007 (estimated)
- 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 to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile-bearing TKA | Experimental | Device: mobile-bearing TKA |
| fixed- bearing TKA | Active comparator | Device: fixed- bearing TKA |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medial medial femorotibial arthritis requiring an arthroplasty
- Age between 50y and 90y
Key exclusion criteria (5 listed)
- Lateral femorotibial arthritis
- Inflammatory disease
- Stiff knee with flexion under 90°
- Revision TKA
- Previous surgery (except meniscectomy)
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 |
|---|---|---|
| mobile-bearing TKA | Device | mobile-bearing TKA |
| fixed- bearing TKA | Device | fixed- bearing TKA |
Primary outcome
International Knee Society Score
Time frame: 2, 6 and 12 monthes after surgery
3 secondary outcomes
Patellofemoral tilt on skyline view, measurement of two angles :
Time frame: 2 and 12 monthes after surgery
patellar tilt
Time frame: 2 and 12 monthes after surgery
patellar displacement from the center of the trochlear groove
Time frame: 2 and 12 monthes after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 33151364Sappey-Marinier E, Swan J, Maucort-Boulch D, Batailler C, Malatray M, Neyret P, Lustig S, Servien E. No significant clinical and radiological differences between fixed versus mobile bearing total knee replacement using the same semi-constrained implant type: a randomized controlled trial with mean 10 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):603-611. doi: 10.1007/s00167-020-06346-1. Epub 2020 Nov 5.
- Results publication: PubMed 31218390Sappey-Marinier E, de Abreu FGA, O'Loughlin P, Gaillard R, Neyret P, Lustig S, Servien E. No difference in patellar position between mobile-bearing and fixed-bearing total knee arthroplasty for medial osteoarthritis: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 2020 May;28(5):1542-1550. doi: 10.1007/s00167-019-05565-5. Epub 2019 Jun 19.
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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. This study is not recruiting at the moment.
Philippe Neyret, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-bearing TKA and fixed- bearing TKA in people with Knee Arthritis, run by Hospices Civils de Lyon 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Society Score (time frame: 2, 6 and 12 monthes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435357, which also lists 2 linked publications.
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 May 2026.