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.

NCT07313449 | Recruiting

• 1 other identifier: 9534
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

Osteonecrosis; Hip Osteoarthritis

Outcome Measures

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

  Up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteonecrosis

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François BONNOMET, MD, PhD

CONTACT

33 3 68 76 52 82; Francois.bonnomet@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: January 31, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)