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临床试验/NCT04769544
NCT04769544招募中不适用

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

Elda University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
The Knee Society Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
50 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

The Knee Society Score

时间窗: 2 years

Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater

次要结局

未报告次要终点

研究者

发起方
Elda University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Lizaur-Utrilla, PhD, MD

Head of Orthopaedic Surgery Department

Elda University Hospital

研究点 (2)

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