跳至主要内容
临床试验/CTRI/2025/12/099440
CTRI/2025/12/099440尚未招募不适用

Prospective evaluation of spinal canal remodeling and clinical recovery after MIS-TLIF and open TLIF: Correlation of clinical and functional outcome with improvement in spinal canal diameter

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月29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
200
试验地点
1

研究概览

简要总结

The study will include consecutive adult patients (Greater than 18 years) diagnosed with degenerative lumbar spondylolisthesis and moderate-to-severe central canal stenosis on MRI, whose surgeons have already planned surgery using either MIS-TLIF or open TLIF. Consecutive enrolment during a 12-month window will reduce selection bias and reflect real-world practice.

Each patient will be followed for 12 months after surgery, allowing analysis of early recovery, radiological canal remodeling, and postoperative complications. All surgeries will be performed at a single centre by experienced surgeons using standardized operative steps (decompression, discectomy, cage insertion, and pedicle-screw fixation), ensuring uniformity of technique so that any differences observed later can be attributed mainly to the type of surgical approach rather than surgeon variability.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Radiologically confirmed degenerative lumbar spondylolisthesis with moderate-to-severe central canal stenosis.
  • Planned transforaminal lumbar interbody fusion (minimally invasive or open).
  • Single-level or multilevel fusion (two or more levels as clinically indicated; no upper limit).
  • Willing and able to provide consent and comply with postoperative follow-up.

排除标准

  • History of prior lumbar instrumentation or decompression at the index level.
  • Presence of lumbar spine trauma, infection, neoplasm, or major spinal deformity (e.g., scoliosis greater than 20° Cobb angle).
  • Contraindication to magnetic resonance imaging (e.g., pacemaker, metallic implant incompatible with MRI).
  • Patient refusal to participate or inability/unwillingness to complete scheduled follow-up evaluations.

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

研究点 (1)

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