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临床试验/CTRI/2026/03/106207
CTRI/2026/03/106207招募中不适用

EFFECT OF COMPONENT ROTATIONAL ALIGNMENT ON FEMORO-TIBIAL ROTATIONAL ALIGNMENT IN TOTAL KNEE ARTHROPLASTY

DR ALAN AJAYAN PHILIP1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
1

研究概览

简要总结

Rotational Alignemnt is goof dor functional outcome and long term success of Total Knee Arthroplasty. Malalignment causes- 1)Patellofemoral complications such s Subluxation, Dislocation, Wear and tear. 2)Abnormal internal and external alignment can cause instability, implant loosening and unexplained painful total knee arthroplasty.. Achieving correct femoro-tibial rotation is difficult with both conventional and navigation systems. Alignment errors after TKA has led to rigorous evaluation of surgical techniques. Alignment in trnasverse plane is problematic due to- 1)Errors of component malalignemnt relative to bone anatomical landmark 2)Mismatch between femoral and tibial components relative position. Both resulting in small rotational errors.

This prospective study evaluates whether component malalignement and mismatch affects the axial rotation motion during passive knee flexion after total knee arthroplasty

This is a prospective study is on the patients that are admitted in Acharya Vinoba Bhave Rural Hospital, Sawanghi(Meghe) that are willing to undergo Total Knee Arthroplasty between June 2025 and December 2027.

Consecutive sampling method will be used. A total sample size of 45 knees will be taken into account using formula developed by William G. Cochran

Postoperative assessment of rotational alignment will be evaluated using CT scan. Femoral component alignment relative to Surgical Transepicondylar axis. Tibial component alignment relative to Akagi’s line.

Postoperative femorotibial rotation on passive flexion of knee will be assessed using Xray Radiography

Functional outcome scores using KSS score, WOMAC score will be done to assess pain and limitations following TKA

Bases on the results of CT scan the participants will be categorised into nominal group(Femoral component rotation <3, Tibial component rotation <10, Femorotibial rotation <5) and Outlier group(Femoral component rotation >3, Tibial component rotation >10, Femorotibial rotation >5)

Statistical Analysis will be done using

Descriptive statistics

Test for normalcy using Shapiro Wilk Test, Histogram, Q-Q plots

Inferential statistics using Independent t-test/Mann Whitney U test, One way ANOVA, Chi-Square test, Pearson/Spearman correlation coefficient

A p-value <0.005 will be considered significant

This study seeks to improve functional outcomes, patient satisfaction, implant longevity in total knee arthroplasty by addressing one of its most common yet underevaluated causes of failure; rotational malalignment

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to undergo Total knee arthroplasty -Patients between the ages of 40-80 years of age.

排除标准

  • Patients with pre-existing hip and ankle deformities -Patients with previous knee surgery over the same limb -Patients with inflamatory arthropathies or pathological conditions that may obscure measuring lanmarks -Post operative complications that may affect rotational measurement.

研究者

发起方
DR ALAN AJAYAN PHILIP
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Alan Ajayan Philip

JNMC WARDHA, SAWANGHI(MEGHE)

研究点 (1)

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