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RecruitingNCT07313449PTG-AnatomicUpdated Jan 2, 2026

Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.

An observational study in Hip Osteoarthritis, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
960
Ages
18 Years and older
Sex
All
01

Study summary

The knee replacement market is experiencing constant growth. Alongside this growth, there is also an increasing interest in customizing implantation based on specific phenotypes to restore the morphology of the native knee. For example, in the last five years, 2019 publications on knee prosthesis alignment have been identified on PubMed.

It seems worthwhile to study and analyze the performance of the prosthesis used in the Orthopedic Surgery Department of the Strasbourg University Hospitals (HUS) and to compare it with results from the literature.

02

Conditions studied

  • Hip Osteoarthritis

Keywords

  • Osteonecrosis
  • Hip Osteoarthritis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patient who underwent total knee replacement (TKR) between January 2013 and December 2024

- Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR

Inclusion criteria

  • Adult patient
  • Patient who underwent total knee replacement (TKR) between January 2013 and December 2024
  • Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
  • Patient operated on by Professor F. Bonnomet
  • Available radiological data: preoperative, immediate postoperative, and postoperative at a minimum of 1 year follow-up

Exclusion criteria

Exclusion Criteria:

- Revision of the arthroplasty during the study follow-up period for a cause not investigated in the study

04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
960 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. IKS / KSS (Knee Society Score)

    The classic IKS (often called KSS) has 2 separate scores, each out of 100 points: 1. Knee Score (Objective / Clinical) - 0 to 100 Assesses the knee itself: * Pain (0-50) * Range of motion (0-25) * Stability (0-25) 2. Function Score - 0 to 100 * Assesses patient function: * Walking distance (0-50) * Stair climbing (0-50) Interpretation (commonly used): * 80-100: Excellent * 70-79: Good * 60-69: Fair * \< 60: Poor

    Time frame: Up to 12 months

06

Study locations

1 of 1 sites recruiting
  • Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • François BONNOMET, MD, PhD · Contact · Francois.bonnomet@chru-strasbourg.fr · 33 3 68 76 52 82
    • François BONNOMET, MD, PhD · Principal investigator
    • Thibaut GOETSCH, Statistician · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT07313449
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Jan 31, 2025
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jan 2, 2026

Study contacts

François BONNOMET, MD, PhD
Contact
Francois.bonnomet@chru-strasbourg.fr
33 3 68 76 52 82

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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