Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty

NCT ID: NCT04769544

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-12-31

Brief Summary

The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.

In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.

In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.

Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.

The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.

Detailed Description

Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.

At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:

1. Study group: patients treated with a medial pivot TKA.

2. Control group: patients treated with a conventional TKA. Patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Medial pivot group

Device used: medial pivot total knee arthroplasty design

Group Type: ACTIVE_COMPARATOR

total knee arthroplasty with medial pivot tibial insert or symmetrical insert

Intervention Type: DEVICE

standard surgical implantation of total knee arthroplasty

Conventional group

Device used: conventional total knee arthroplasty design

Group Type: ACTIVE_COMPARATOR

total knee arthroplasty with medial pivot tibial insert or symmetrical insert

Intervention Type: DEVICE

standard surgical implantation of total knee arthroplasty

Interventions

total knee arthroplasty with medial pivot tibial insert or symmetrical insert

standard surgical implantation of total knee arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary osteoarthritis of the knee
• 50 years and older
• Participants must be able to give informed consent

Exclusion Criteria

• Inflammatory arthritis
• Traumatic etiology
• Neurologic disease
• Neoplastic disease
• Morbid obesity
• Severe collateral ligament instability (> 10° varus/valgus)
• Severe knee misalignment (greater than 10° of varus or valgus)
• Flexion contracture greater than 15º
• Prior surgery on the affected knee (except meniscus)
• Knee arthroplasty in the contralateral knee

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: collaborator

Elda University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Lizaur-Utrilla, PhD, MD

Head of Orthopaedic Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alejandro Lizaur-Utrilla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Elda University Hospital

Locations

Elda University Hospital

Elda, Alicante, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alejandro Lizaur-Utrilla, MD, PhD

Role: CONTACT

lizaur1@telefonica.net

+34 966989019

Facility Contacts

Alejandro Lizaur-Utrilla, PhD, MD

Role: primary

lizaur1@telefonica.net

Other Identifiers

MedialPivotPTR2021

Identifier Type: -

Identifier Source: org_study_id