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Migration of CS vs CR Insert in TKA Using RSA

NCT05936593 · Reinier Haga Orthopedisch Centrum · Updated 18 Dec 2023

What is being tested
Condylar Stabilizing (CS) insert; Cruciate Retaining (CR) insert
For
Wear of Articular Bearing Surface of Prosthetic Joint; Migration of Implant
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 70 years. About 44 people. The full rules are on the registry page.
Where
Netherlands
When
Starts or started 21 July 2023, ends June 2035. Registered 10 July 2023.
Results
None posted yet.

In the researchers' words

Background: The choice whether or not to preserve the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) is coupled to the us of a PCL-retaining (CR) or a condylar (CS) insert. The CS insert is anterior-lipped (AL) to prevent anterior translation of the femur on the tibia with flexion and compensate the function of the PCL. Currently both the CR and CS insert are made of highly cross-linked polyethylene (HXPLE) to theoretically reduce wear related osteolysis. However, this also might diminish the fracture toughness and crack propagation of the insert. The investigators expect that due to the high contact forces on the anterior lip of the CS insert during flexion, especially in younger and more active patients, and the lower fracture toughness of HXPLE, the CS insert insert might show more migration, wear or other damage compared to the CR insert in the long-term, which might lead to more revisions in the CS insert compared to the CR insert. To measure the migration and wear, during surgery tantalum markers will be inserted in the host bone using a marker inserter. The displacement of the prosthesis with reference to the host bone will be measured using model-based RSA. Both tantalum markers ande the inserter are already used for study purposes. However, the safety and usability are not registered before. Objective: The primary objective is to compare the…
ClinicalTrials.gov, NCT05936593

Sites

  • Reinier Haga Orthopedisch CentrumZoetermeer, South Holland, Netherlands