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临床试验/CTRI/2024/01/062034
CTRI/2024/01/062034已完成3 期

THE COMPARISON OF CLINICAL AND RADIOLOGICALOUTCOMES OF TOTAL HIP ARTHROPLASTY WITH DIRECTANTERIOR APPROACH VERSUS POSTERIOR APPROACH –A RANDOMISED CONTROL TRIAL

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月2日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
To compare the clinical and radiological outcomes of THA with direct anterior approach

研究概览

简要总结

The study aims to compare the clinical and radiological outcomes in patients undergoing Total Hip Arthroplasty (THA) with direct anterior approach (DAA) versus posterior approach. Blood tests, MRI, EOS scan, Gait analysis, Radiological and clinical evaluation shall be done at preoperative period, immediate postop period, and at 2 weeks, 6 weeks, 3 months and 1 year postoperatively.  Primary objectives being:

• To compare tissue damage between Direct Anterior Approach (DAA) versus Posterior Approach THA by blood tests and MRI.

• To compare functional outcomes between DAA vs Posterior approach THA using patient reported outcome scores and Gait analysis.

• To compare rate of return to activities of daily living using a milestone diary.

• To compare the radiological outcomes between the two groups for optimal implant positioning and leg length using standard radiographs and EOSTM scan.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged between 18-70 years with unilateral symptomatic hip arthritis undergoing unilateral cementless THA.

排除标准

  • Patients with previous prosthetic hip replacement devices/ revision surgeries.
  • Patients aged less than 18 years or more than 70 years.
  • Patients with the presence of infections- highly communicable diseases like AIDS, venereal diseases, hepatitis, pulmonary tuberculosis.
  • Patients undergoing simultaneous hip and knee arthroplasty.
  • Patients not giving consent.
  • Patients with Crowe 3 and 4 hip dysplasias.
  • Patients with neuromuscular disorders or musculoskeletal disorders or diseases that may adversely affect normal weight bearing or gait
  • Patients with active major psychiatric illness or active metastatic disease.
  • Patients with spinopelvic involvement and difference in sacral slope in standing and sitting lateral spine x ray less than 10º.

结局指标

主要结局

To compare the clinical and radiological outcomes of THA with direct anterior approach

时间窗: Preoperative period upto 1 year of Postoperative follow up, including regular follow ups at 2 weeks, 6 weeks, 3 months and 1 year.

(DAA) versus posterior approach.

时间窗: Preoperative period upto 1 year of Postoperative follow up, including regular follow ups at 2 weeks, 6 weeks, 3 months and 1 year.

次要结局

  • • To compare tissue damage between Direct Anterior Approach (DAA) versus Posterior Approach THA by blood tests and MRI.(• To compare functional outcomes between DAA vs Posterior approach THA using patient reported outcome scores and Gait analysis.)

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution and hospital

研究点 (1)

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