NCT03692845

Brief Summary

A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Status
unknown

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

September 28, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 28, 2018

Last Update Submit

October 1, 2018

Conditions

Spinal Fusion

Keywords

spine fusionminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability index(Arabic version) 1 month

    an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

    1 month

Secondary Outcomes (1)

  • • Fusion rate as assessed by Bridwell fusion score.

    1 year

Study Arms (2)

O-TLIF group

OTHER

Spinal fusion ,Transforaminal lumbar interbody fusion procedure will be performed through open surgery.

Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive

MI-TLIF group

OTHER

Spinal fusion,Transforaminal lumbar interbody fusion procedure will be performed through minimally invasive surgery using a tubular retractor.

Procedure: Transforaminal Lumbar Interbody Fusion either open or minimally invasive

Interventions

Transforaminal Lumbar Interbody Fusion either open or minimally invasivePROCEDURE

Spinal fusion procedure through the intervertebral foramen

MI-TLIF groupO-TLIF group

Eligibility Criteria

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

You may qualify if:

  • Adults more than 18 years of age and less than 65 years of age..
  • Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
  • Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
  • Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
  • Symptoms not responding to conservative treatment for at least 3 months.

You may not qualify if:

  • Previous spinal fusion or instrumentation.
  • Spinal tumours, infection and fractures.
  • Patients with severe osteoporosis
  • BMI more than 35.
  • Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
  • Patients not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 2, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2020

Study Completion

October 1, 2021

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share