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临床试验/CTRI/2024/07/071637
CTRI/2024/07/071637尚未招募不适用

Comparison of gait following Mechanically Aligned and callipered restricted Kinematically Aligned Total Knee Arthroplasty - A Randomized Controlled Trial

Dr Kshitij Gupta1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Maximum knee flexion angle during swing phase

研究概览

简要总结

Osteoarthritis (OA) is a debilitating condition which alters the biomechanics of the gait cycle. End stage patients need to be managed by Total Knee Arthroplasty (TKA) to alleviate pain and improve gait dynamics. There are various types of coronal alignments proposed for TKA- Mechanical alignment (MA-TKA) and restricted kinematic alignment (rKA-TKA) being one of them. While MA-TKA restores the knee into a rectus alignment, rKA-TKA aims to restore the native alignment of the original knee within the acceptable limits. The literature has shown that MA-TKA gives the patient a gait different from the normal gait pattern. The aim of the study is to ascertain if rKA-TKA is able to give better gait dynamics to the patient as compared to MA-TKA.

The null hypothesis of the study is that there is no difference in the gait pattern between the two groups of TKA.

This is a single centre randomised controlled trial comparing the dynamic gait biomechanics between two different types of Total Knee Arthroplasties- MA-TKA and rKA-TKA. Blinding of the patient and observer will be done. The primary outcome of the study are maximum knee flexion in swing phase and knee adduction moment in stance phase at 6 months post-operative period. The secondary objectives are comparison of other temporal, spatial, kinematic and kinetic gait variables and patient reported outcome measures at 6 months post-operative period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • • All patients posted for simultaneous single staged B/L TKA • More than one compartmental primary OA with pain interfering with their ADL • MPTA between 5-10° varus • KL Grade 3/4 • ASA grade 1 and 2.

排除标准

  • • Any patient with previous knee surgery • Extra-articular knee deformity • Any spine disorder which may interfere with mobilization • Revision TKA cases • Inflammatory Arthritis • FFD 15° or more degrees • Clinically uncorrectable Valgus/Varus deformity of 15° or more • Any previous ligament surgery/reconstruction • Previous history Septic Arthritis knee.

结局指标

主要结局

Maximum knee flexion angle during swing phase

时间窗: Pre-operatively and 6 months post-operatively

Maximum knee adduction moment in overall stance phase

时间窗: Pre-operatively and 6 months post-operatively

次要结局

  • Comparison of other temporal, spatial, kinematic and kinetic gait variables(Pre-operatively and 6 months post-operatively)
  • Comparison of Patient reported outcome measures (PROMs)(Pre-operatively and 6 months post-operatively)

研究者

发起方
Dr Kshitij Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kshitij Gupta

All India Institute of Medical Sciences, Rishikesh

研究点 (1)

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