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Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery

Q

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Invitation-only

Conditions

Foraminal Stenosis

Treatments

Procedure: Endoscopic Foraminotomy Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06685575
020/2567

Details and patient eligibility

About

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

Full description

Backgrounds :

Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.

Objectives :

To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis

Methods :

This is an ambi-directional cohort study, In retrospective part conducted from JAN2019-JAN2024 in Queen Savang Vadhana Memorial Hospital and the prospective part conducted from AUG2024 - JUNE 2025, Thailand. 60 patients presented with stable lumbar foraminal stenosis were divided into posterior decompression with conventional transforaminal lumbar interbody fusion (TLIF) group ( N=30) and full-endoscopic lumbar foraminoplasty (FELF) group (N=30). Demographic data and pre-perioperative parameters were analyzed. For TLIF group , Standard procedure had been performed.

Posterior decompression, pedicle screws and interbody cage ( Mont blanc, Spineway, France) insertion under image intensifier ( BV Pulsera,Philips).For endoscopic foraminoplasty , uniportal stenoscope ( Vertebris ,Riwospine ) was used to perform endoscopic decompressive surgery. Post-operative outcome , for instance , Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) were recorded at preoperative, post-op day1, 3 month, 6 month and 1 year respectively. Other parameters such as estimated blood loss (EBL), length of hospital stay and post- operative complications were also recorded

Enrollment

52 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 30-80
  • Persist radiculopathy and sciatica pain
  • Patient that was diagnosed Stable lumbar foraminal stenosis
  • Failed conservative for at least 6 months
  • Patients who willing to join the study

Exclusion criteria

  • Patients with unstable lumbar foraminal stenosis
  • Patient with spine infection or tumor or fracture
  • Patient with BMD less than -2.5 or osteopenia
  • Patient with inflammatory joint diseases who on steroids
  • Patient who has undergo with surgery that inserted metals in back
  • Unable to answer questionnaires
  • Cannot tolerate surgery due to severe medical comorbidities

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery
No Intervention group
Description:
standard surgery for foraminal stenosis
Endoscopic Foraminotomy Surgery
Experimental group
Description:
The new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine
Treatment:
Procedure: Endoscopic Foraminotomy Surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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