跳至主要内容
临床试验/CTRI/2019/10/021517
CTRI/2019/10/021517尚未招募不适用

Influence of Total knee replacement on concomitant back pain and its correlation with functional outcome and patient satisfaction.

Ganga medical centre and hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To evaluate the prevalence of low back pain in patients with end stage knee arthritis undergoing TKR.

研究概览

简要总结

All the patients undergoing primary TKR meeting inclusion criteria with or without LBA during study period were taken into study.

Group A: With the low backache

Group B: Without low backache (control group)

 All the patients were clinically examined and functional scores recorded. The scores taken were VAS score for pain, Oswestry disability index for back pain, SF-12 for patient-reported outcome measure and Knee society score for knee function.

 Radiologically, Both groups- Standard TKR Protocol radiographs ( Alignment Xray, Knee Anteroposterior and skyline views) taken.

•Whole spine Xray- AP, lateral (Standing)

•Dynamic views â€“ if symptomatic

•MRI ( to stratify based on diagnosis)- if symptomatic

 The patient will undergo standard total knee replacement and postoperative protocol. After total knee replacement, both groups assessed with clinical scores and radiological criteria at 6 months and 1 year follow up.

 Statistical analysis used for comparison between groups:

•       Student’s t-test for continuous variables

•       Chi-squared test and Fisher’s exact test for categorical variables.

For comparison between pre- and postoperative data within a group:

•       Paired t-test or Wilcoxon signed-rank test

•       Correlation- assessed by the Spearman coefficient.

•       Statistical significance was considered for P values less than 0.05

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patient undergoing TKR with or without LBA.
  • Degenerative osteoarthritis.

排除标准

  • Previous spinal surgery and/or fractures Functional discrepancy of limb length Patient who not able to stand Associated hip pathology Inflammatory arthritis.

结局指标

主要结局

To evaluate the prevalence of low back pain in patients with end stage knee arthritis undergoing TKR.

时间窗: 6 months and 1 year

Influence on back pain on the functional outcome after TKR and vice versa.

时间窗: 6 months and 1 year

次要结局

  • Changes in spinopelvic parameters post TKR (Simultaneous & Staggered).(To compare the radiological changes and PROM in matched cohort population with and without LBA.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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