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
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
Dr Bharat R Dave
Stavya Spine Hospital And Research Institute
