NCT06545032

Brief Summary

The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 6, 2024

Last Update Submit

August 6, 2024

Conditions

Degenerative Spine Diseases

Outcome Measures

Primary Outcomes (1)

  • severity of pain according to visual analog score(vas)

    comparison between pre \& post operative pain

    1 year

Interventions

lumbar fusionPROCEDURE

Minimal Invasive Transforaminal Lumbar Interbody Fusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Degenerative spondylolisthesis.
  • Degenerative unilateral disc herniations.
  • Recurrent disc herniation.

You may not qualify if:

  • Spondylolisthesis Grade III or IV.
  • Degenerative scoliosis .
  • Traumatic fracture spine.
  • Infections.
  • Neoplasms.
  • Debilitated patients .
  • Coagulation dysfunction.
  • Severe osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PMID: 11074683BACKGROUND

  • Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep.

    PMID: 35783004BACKGROUND

  • Jang HD, Lee JC, Choi SW, Hong CH, Suh YS, Shin BJ. A novel surgical approach using the "lateral corridor" for minimally invasive oblique lumbar interbody fusion at L5-S1: a clinical series and technical note. Eur Spine J. 2024 Jul;33(7):2611-2620. doi: 10.1007/s00586-024-08217-6. Epub 2024 May 31.

    PMID: 38819738BACKGROUND

  • Le H, Anderson R, Phan E, Wick J, Barber J, Roberto R, Klineberg E, Javidan Y. Clinical and Radiographic Comparison Between Open Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion With Bilateral Facetectomies. Global Spine J. 2021 Jul;11(6):903-910. doi: 10.1177/2192568220932879. Epub 2020 Jun 22.

    PMID: 32677520BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08