NCT05238662

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

● 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.

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.

Conditions

• Treatment

Interventions

Type	Name	Description
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
PROCEDURE	pedicle screw fixation and interbody cage on the same side	pedicle screw fixation and interbody cage on the same side

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2022-02-14
• Last updated: 2022-02-14