Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Spinal Fusion Clinical Trial

Official title:

Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03692845
• Other study ID #: 6272829
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: October 2021

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fusion

Intervention

Procedure:
• Transforaminal Lumbar Interbody Fusion either open or minimally invasive
Spinal fusion procedure through the intervertebral foramen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• Fusion rate as assessed by Bridwell fusion score.	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.	1 year