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

NCT03081260 | Completed

• 2 other identifiers: 69HCL16_06452016-A01697-44
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty

Keywords

Total Knee Arthroplasty; Patella; Resurfacing; IKS score

Outcome Measures

Primary Outcomes (1)

• measure of International Knee Society score (IKS score)

  The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.

  12 months after surgery

Secondary Outcomes (2)

• abnormality of the patellar stroke

  12 months after surgery

• Measure of the forgotten joint score

  12 months after surgery

Study Arms (2)

Patellar resurfacing

OTHER

Patellar resurfacing during the total knee prosthesis Anatomic surgery

Other: Patellar resurfacing

Patellar non-resurfacing

OTHER

Patellar non-resurfacing during the total knee prosthesis Anatomic surgery

Other: Patellar non-resurfacing

Interventions

Patellar resurfacing 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 resurfacing

Patellar non-resurfacing OTHER

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

Patellar non-resurfacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• 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.

  PMID: 33661323 RESULT

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Sebastien Lustig, MD

  Hôpital de la Croix-Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 16, 2017
• Study Start: April 3, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (1)