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

NCT06052579 | Completed DMC

• 1 other identifier: NFEC-2022-309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Stenosis; Spondylolisthesis

Keywords

Wiltse approach TLIF; transforaminal lumbar interbody fusion; hand-held retractors system

Outcome Measures

Primary Outcomes (1)

• the degree of paraspinal muscle degeneration

  the infiltration of fat and connective tissue are mainly manifested as enhanced signals on T2-weighted imaging

  6 months postoperatively

Secondary Outcomes (1)

• the degree of paraspinal muscle degeneration

  Preoperative,7 days, 3, 6, and 12 months after surgery

Study Arms (2)

study group

EXPERIMENTAL

the patients included in the study group underwent Wiltse TLIF

Procedure: new hand-held retractor systems-assisted WiltseTLIF surgery

control group

ACTIVE COMPARATOR

the patients included in the control group underwent traditional posterior -TLIF

Procedure: new hand-held retractor systems-assisted WiltseTLIF surgery

Interventions

new hand-held retractor systems-assisted WiltseTLIF surgery PROCEDURE

patients were included in study group underwent the new hand-held retractors assisted Wiltse TLIF surgery

control group; study group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients underwent either one or two-level spinal fusion surgery due to lumbar stenosis, grade 1 or 2 spondylolisthesis, or lumbar disc herniation with lumbar instability and mechanical lower back pain

You may not qualify if:

• Patients with lumbar infection (i), spinal tumor (ii), severe osteoporosis (iii), pregnant and lactating women (iv), severe lumbar stenosis (v), and severe comorbidities (vi)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Division of Spinal Surgery, Department of Orthopaedics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Shen X, Li FT, Quan Cheng Y, Zheng MH, Yao XQ, Wang HM, Ting Chen J, Jiang H. 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. BMC Musculoskelet Disord. 2024 Feb 14;25(1):142. doi: 10.1186/s12891-024-07248-w.

  PMID: 38355528 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic; Spondylolisthesis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Xing Shen, M.D

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This one-year prospective controlled study compared two approaches (Wiltse TLIF vs P-TLIF) for hand-held retractors-assisted TLIF was approved by the Institutional Review Board (IRB) of our hospital. Written informed consent was obtained from all study participants. 60 eligible patients were included in this study and were divided into two groups.30patientswere included in the study group and underwent Wiltse TLIF, and 30 were included in the control group and underwent P-TLIF.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: June 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)