Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03692845

Enrollment

Registered

2018-10-02

Start date

2018-11-30

Completion date

2021-10-31

Last updated

2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion

Keywords

spine fusion, minimally invasive surgery

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.

Detailed description

The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

Interventions

PROCEDURETransforaminal Lumbar Interbody Fusion either open or minimally invasive

Spinal fusion procedure through the intervertebral foramen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Oswestry Disability index(Arabic version) 1 month	1 month	an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

Secondary

Measure	Time frame	Description
• Fusion rate as assessed by Bridwell fusion score.	1 year	Grade I is defined as fusion with remodelling and trabeculae present; Grade II is an intact graft with incomplete remodelling and no lucency present; Grade III is an intact graft with potential lucency at the cranial or caudal end; Grade IV is absent fusion with collapse/resorption of the graft.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026