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Changes in Spinal Canal Size and Patient Recovery After Lumbar Spine Surgery: A Prospective Study

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099440
Enrollment
200
Registered
2025-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M480- Spinal stenosis

Interventions

Intervention1: NIL.: NIL. Intervention2: Nil: Nil Control Intervention1: NIL.: NIL.

Sponsors

Stavya Spine Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Radiologically confirmed degenerative lumbar spondylolisthesis with moderate-to-severe central canal stenosis. 2. Planned transforaminal lumbar interbody fusion (minimally invasive or open). 3. Single-level or multilevel fusion (two or more levels as clinically indicated; no upper limit). 4. Willing and able to provide consent and comply with postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. History of prior lumbar instrumentation or decompression at the index level. 2. Presence of lumbar spine trauma, infection, neoplasm, or major spinal deformity (e.g., scoliosis greater than 20 Cobb angle). 3. Contraindication to magnetic resonance imaging (e.g., pacemaker, metallic implant incompatible with MRI). 4. Patient refusal to participate or inability/unwillingness to complete scheduled follow-up evaluations.

Design outcomes

Primary

MeasureTime frame
To quantify changes in back and leg pain (10-cm Visual Analogue Scale) and disability (Oswestry Disability Index) from baseline to the immediate postoperative period, postoperative day 1, postoperative day 2, and at 3, 6, and 12 months. To measure radiological changes on MRI including dural sac cross sectional area and spinal canal cross sectional area, at baseline, 6 months, and 12 months. To correlate radiologic improvement, particularly change in dural sac cross sectional area, with clinical and functional recovery measured by the Visual Analogue Scale and the Oswestry Disability Index at matched time points. Timepoint: All enrolled patients will be prospectively evaluated at baseline (Day 0, date of surgery) and followed up at 3, 6 and 12 months postoperatively for serial clinical, functional, and radiological assessments—

Secondary

MeasureTime frame
NIL.Timepoint: NIL.—

Countries

India

Contacts

Public ContactDr Bharat R Dave

Stavya Spine Hospital And Research Institute

brd_172@yahoo.com09825019913

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026