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

Arthroplasty Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081260
• Other study ID #: 69HCL16_0645
• Secondary ID: 2016-A01697-44
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty

Intervention

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.
• Patellar non-resurfacing
Non-resurfacing of the patella does not involve any additional surgical action

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	abnormality of the patellar stroke	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
Secondary	Measure of the forgotten joint score	The comparison of the forgotten joint score will be done between both groups.	12 months after surgery