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临床试验/CTRI/2025/09/095196
CTRI/2025/09/095196尚未招募不适用

Impact of consideration of Spinopelvic Mobility on Functional outcomes in total hip Arthroplasty for patients with Low Back Ache: A Randomized Control Trial.

Jawaharlal Nehru Medical College, Wardha1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年10月7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
26
试验地点
1
主要终点
Functional outcome after THA, measured by Harris Hip Score (HHS) at 12 months post-surgery.

研究概览

简要总结

This study is a randomized controlled trial designed to evaluate the impact of considering spinopelvic mobility during preoperative planning on functional outcomes in patients with chronic low back pain who undergo total hip arthroplasty. Adult patients (aged 18 and above) with hip osteoarthritis and chronic low back ache will be recruited, subject to inclusion and exclusion criteria. After randomization, the intervention group will undergo a detailed spinopelvic assessment—both clinical and radiological—including standing and sitting spine-pelvis radiographs to measure pelvic incidence, pelvic tilt, sacral slope, and lumbar flexibility. Conventional preoperative assessment without targeted spinopelvic evaluation will be done in the control group. Surgery will follow standardized protocols, with implant positioning based on spinopelvic parameters in the intervention group and conventional alignment in controls. Outcomes including the Harris Hip Score, SF-36 for back pain, radiological cup placement parameters, and gait analysis will be assessed at baseline, 6 weeks, 3 months, and 6 months postoperatively. The study will be conducted at the Department of Orthopaedics, Jawaharlal Nehru Medical College & Acharya Vinoba Bhave Rural Hospital, Wardha, from October 2025 onwards, enrolling a minimum of 26 patients. Ethical approval has been obtained from the Institutional Ethics Committee, and informed consent will be secured from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults with hip osteoarthritis and chronic low back ache undergoing primary Total Hip Replacement -Able to undergo sitting and standing radiographs of lumbosacral spine.

排除标准

  • Revision Hip Arthroplasty -Neurological disorders -Any other condition affecting True Outcome Analysis based on criteria included Randomization and Groups.

结局指标

主要结局

Functional outcome after THA, measured by Harris Hip Score (HHS) at 12 months post-surgery.

时间窗: Baseline (pre-operative), 3 months, 6 months, and 12 months post-surgery.

次要结局

  • Gait analysis of randomly selected patients on Xsens Analyse system(Baseline (pre-operative), 3 months, 6 months, & 12 months post-surgery.)

研究者

发起方
Jawaharlal Nehru Medical College, Wardha
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Trish Chetan Shetty

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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