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NCT Number: NCT07313449

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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

François BONNOMET, MD, PhD

CONTACT

[email protected]

33 3 68 76 52 82

François BONNOMET, MD, PhD

PRINCIPAL_INVESTIGATOR

Thibaut GOETSCH, Statistician

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. IKS / KSS (Knee Society Score)

    Time frame: Up to 12 months

    The classic IKS (often called KSS) has 2 separate scores, each out of 100 points:

    • Knee Score (Objective / Clinical) - 0 to 100

    Assesses the knee itself:

    • Pain (0-50)
    • Range of motion (0-25)
    • Stability (0-25)
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

François BONNOMET, MD, PhD

CONTACT

[email protected]

33 3 68 76 52 82

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PTG-Anatomic

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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