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Comparison of Clinicoradiological Outcomes in Patients Undergoing Transforaminal Lumbar Intervertebral Fusion via Unilateral Biportal Endoscopy vs Open approach

Comparison of Clinicoradiological Outcomes in Patients Undergoing Transforaminal Lumbar Intervertebral Fusion via Unilateral Biportal Endoscopy vs Open approach; an Open Non-Inferior Randomised controlled trial study - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080261
Enrollment
48
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: TRANSFORAMINAL LUMBAR INTERVERTEBRAL FUSION VIA UNILATERAL BIPORTAL ENDOSCOPY: patients who are diagnosed with degenerative spine disorders will undergo Thoracolumbar intervertebral fus

Sponsors

No sponsor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than or equal to 18 years degenerative spondylolisthesis at one level Severe lumbar canal stenosis at one level Recurrent prolapsed intervertebral disc at one level Lytic listhesis at one level Patients who are willing to follow up for a minimum of 12 months

Exclusion criteria

Exclusion criteria: Patient with tandem spinal stenosis Patient with spondylodiscitis Patient with disseminated active infection Pregnant women Patients with traumatic spinal injury, severe osteoporosis, spinal tumors. Patients who are unfit to undergo spinal surgery Patients having severe mental insufficiency-like those with Parkinsonism, Alzheimer s disease and other neurological disorder. Patients with adult spinal deformity like degenerative scoliosis or coronal imbalance Patient with more than one level pathogenesis

Design outcomes

Primary

MeasureTime frame
To compare clinico radiological outcomes of patients undergoing Transforaminal lumbar intervertebral fusion via open vs UBE methodTimepoint: preop, post-op day-01 , day 7,2 weeks, 6weeks,3 months and 6 months

Secondary

MeasureTime frame
By measuring the amount of graft obtained from both open & unilateral biportal endoscopy method in a syringe in terms of ml Complications, immediate & late at 3 months & 6 months Timepoint: immediate post op & at 3 months & 6 months

Countries

India

Contacts

Public ContactDr Avinash Kumar

AIIMS patna

dravinashk@aiimspatna.org8789483273

Outcome results

None listed

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