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

NCT ID: NCT03081260

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2020-02-28

Brief Summary

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.

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.

Conditions

Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patellar resurfacing

Patellar resurfacing during the total knee prosthesis Anatomic surgery

Group Type: OTHER

Patellar resurfacing

Intervention Type: OTHER

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.

Patellar non-resurfacing

Patellar non-resurfacing during the total knee prosthesis Anatomic surgery

Group Type: OTHER

Patellar non-resurfacing

Intervention Type: OTHER

Non-resurfacing of the patella does not involve any additional surgical action

Interventions

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.

Intervention Type: OTHER

Patellar non-resurfacing

Non-resurfacing of the patella does not involve any additional surgical action

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastien Lustig, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital de la Croix-Rousse

Locations

Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

Deroche E, Batailler C, Swan J, Sappey-Marinier E, Neyret P, Servien E, Lustig S. No difference between resurfaced and non-resurfaced patellae with a modern prosthesis design: a prospective randomized study of 250 total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):1025-1038. doi: 10.1007/s00167-021-06521-y. Epub 2021 Mar 4.

Reference Type: RESULT

PMID: 33661323 (View on PubMed)

Other Identifiers

2016-A01697-44

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0645

Identifier Type: -

Identifier Source: org_study_id