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. (PTG-Anatomic)

December 17, 2025 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • François BONNOMET, MD, PhD
        • Sub-Investigator:
          • Thibaut GOETSCH, Statistician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  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
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9534 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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