Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage

A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion

● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.

● Alternative hypothesis (H1):

Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.

Study Overview

• Status: Not yet recruiting
• Conditions: Treatment
• Intervention / Treatment: Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided; Procedure: pedicle screw fixation and interbody cage on the same side

Detailed Description

Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation.

Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues.

Sample size:

The Study will include 40 patients divided into two groups, each group containing 20 patients.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wael Elmesallamy, M.D; Phone Number: 002 01142453993; Email: waelmesallamy50@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient acceptance.
• Both sexes.
• Age (21-60) years old.
• Patients with monosegmental lumber degenerative spinal diseases including lumbar spondylosis, spondylolysis, spondylolisthesis grade one, or lumbar disc prolapse.

Exclusion Criteria:

• Patient refusal.
• Altered mental status.
• Patients with associated comorbidity interfere with surgery.
• Extremes of age.
• Multiple level lumbar degenerative disease
• Trauma
• Spinal tumour
• Active infection
• Previous lumbar operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; pedicle screw fixation on one side and intervertebral cage on the other sided	Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided; pedicle screw fixation on one side and intervertebral cage on the other sided
Active Comparator: Group B; pedicle screw fixation and interbody cage on the same side	Procedure: pedicle screw fixation and interbody cage on the same side; pedicle screw fixation and interbody cage on the same side

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of fusion status	Evaluation of fusion status using CT scan and Xray	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back Pain	use of Visual Analogue Scale (VAS) as a 10-cm line labeled with (0= no pain and 10=worst pain)	At 24 hours, 2 weeks and 3 months after surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Wael Elmesallamy, M.D, Zagazig University, Faculty of human medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 9181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No