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Clinical Trials/NCT07313449
NCT07313449
Recruiting
Not Applicable

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.

University Hospital, Strasbourg, France1 site in 1 country960 target enrollmentStarted: January 31, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Strasbourg, France
Enrollment
960
Locations
1
Primary Endpoint
IKS / KSS (Knee Society Score)

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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