Last reviewed · How we verify

NCT06052579

Comparison Of A Novel Hand-held Retractor-Assisted Transforaminal Lumbar Interbody Fusion By The Wiltse Approach And Posterior TLIF

Completed NA Last updated 28 September 2023
What this trial tests

NA trial testing new hand-held retractor systems-assisted WiltseTLIF surgery in Lumbar Stenosis in 60 participants. Completed in 30 June 2023.

Timeline
1 January 2019
Primary endpoint
1 December 2021
30 June 2023

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingsingle
Primary purposetreatment
Enrollment60
Start date1 January 2019
Primary completion1 December 2021
Estimated completion30 June 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 20 to 70, any sex, with Lumbar Stenosis or Spondylolisthesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, hand-held retractors have been applied to assist in Wiltse approach to perform canal decompression, causing less paraspinal muscle injury and yielding better postoperative clinical outcomes than P-TLIF. However, few prospective studies have been conducted comparing the clinical and radiological outcomes between Wiltse TLIF and P-TLIF, both assisted by hand-held retractors. Therefore, further research is warranted to assess whether hand-held retractor-assisted Wiltse TLIF can yield less paraspinal muscle injury and better postoperative clinical outcomes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comparison of a novel hand-held retractor-assisted transforaminal lumbar interbody fusion by the wiltse approach and posterior TLIF: a one-year prospective controlled study.
    Shen X, Li FT, Quan Cheng Y, Zheng MH, et al · · 2024 · cited 3× · PMID 38355528 · DOI 10.1186/s12891-024-07248-w
  2. Comparison Of A Novel Hand-held Retractor-Assisted Transforaminal Lumbar Interbody Fusion By The Wiltse Approach And Posterior TLIF
    Shen X, Li Ft, Chen Yq, Zheng Mh, et al · · 2023 · DOI 10.21203/rs.3.rs-3391204/v1

Verify or expand the search:

Other recruiting trials for Lumbar Stenosis

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06052579.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing