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Completed

NCT Number: NCT03081260

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

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.

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Key information

Conditions

Arthroplasty Fractures, Bone Knee Fractures Patella Fracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 non-resurfacing

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2017
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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