Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty

September 30, 2025 updated by: Hospices Civils de Lyon

Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study

Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.

The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.

In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.

In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.

Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.

There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".

It seems necessary to compare both methods in terms of long-term postsurgery results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Lyon, France, 69004
        • Hopital de la croix rousse

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female (age ≥ 18 years)
  • Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)
  • Indication of total first-line knee arthroplasty

Exclusion Criteria:

  • Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).
  • Refusal to participate in the study
  • Pregnant women, parturients or nursing mothers
  • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
  • Minor Patients
  • Major persons who are subject to a legal protection measure or are unable to express their consent
  • Patient not affiliated to a social security scheme
  • Patient participating in other interventional research excluding routine care studies not interfering with analysis of primary endpoint

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patellar resurfacing
Patellar resurfacing during the total knee prosthesis Anatomic surgery
Other: Patellar resurfacing
The resurfacing of the patella is generally done at the end of the surgery, after having ejected the patella. A frontal bone cut is made using a dedicated ancillary to remove the entire cartilage. Orifices are then made in the patella so that the polyethylene implant can be accommodated with studs which will be cemented on the joint face of the ball joint.
Other: Patellar non-resurfacing
Patellar non-resurfacing during the total knee prosthesis Anatomic surgery
Other: Patellar non-resurfacing
Non-resurfacing of the patella does not involve any additional surgical action

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of International Knee Society score (IKS score)
Time Frame: 12 months after surgery
The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abnormality of the patellar stroke
Time Frame: 12 months after surgery
Presence of an abnormality of the patellar stroke with the type of tilting, subluxation or dislocation of the patella on the X-ray images.
12 months after surgery
Measure of the forgotten joint score
Time Frame: 12 months after surgery
The comparison of the forgotten joint score will be done between both groups.
12 months after surgery

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sebastien Lustig, MD, Hôpital de la Croix-Rousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 3, 2017

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0645
  • 2016-A01697-44 (Other Identifier: ANSM)

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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