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Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty

Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04769544
Enrollment
100
Registered
2021-02-24
Start date
2022-01-01
Completion date
2025-12-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis, Total knee arthroplasty, Medial pivot

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.

Interventions

DEVICEtotal knee arthroplasty with medial pivot tibial insert or symmetrical insert

standard surgical implantation of total knee arthroplasty

Sponsors

Universidad Miguel Hernandez de Elche
CollaboratorOTHER
Elda University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double Blind. Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization. Both patients and evaluators will be blinded with regard to the TKA design.

Intervention model description

Patients will be treated surgically with a TKA. The two patient groups will include: 1) Study group treated a medial pivot TKA; 2) Control group treated with a conventional TKA. Patients will be followed at regular postoperative intervals by orthopaedic surgeons not involved in the surgeries or cares.

Eligibility

Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Knee Society Score2 yearsFunctional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater

Countries

Spain

Contacts

Primary ContactAlejandro Lizaur-Utrilla, MD, PhD
lizaur1@telefonica.net+34 966989019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026