NCT00435357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

February 13, 2007

Last Update Submit

May 13, 2026

Conditions

Keywords

Mobile-bearingarthroplastyfixed-bearingkneepatellaposterior stabilized TKA

Outcome Measures

Primary Outcomes (1)

  • International Knee Society Score

    2, 6 and 12 monthes after surgery

Secondary Outcomes (3)

  • Patellofemoral tilt on skyline view, measurement of two angles :

    2 and 12 monthes after surgery

  • patellar tilt

    2 and 12 monthes after surgery

  • patellar displacement from the center of the trochlear groove

    2 and 12 monthes after surgery

Study Arms (2)

mobile-bearing TKA

EXPERIMENTAL
Device: mobile-bearing TKA

fixed- bearing TKA

ACTIVE COMPARATOR
Device: fixed- bearing TKA

Interventions

mobile-bearing TKA
fixed- bearing TKA

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medial medial femorotibial arthritis requiring an arthroplasty
  • Age between 50y and 90y

You may not qualify if:

  • Lateral femorotibial arthritis
  • Inflammatory disease
  • Stiff knee with flexion under 90°
  • Revision TKA
  • Previous surgery (except meniscectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sebastien Lustig

Lyon, 69300, France

Location

Related Publications (2)

  • 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.

  • Sappey-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.

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Philippe Neyret, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 14, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations