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

Not Applicable

• Conditions: Treatment
• Interventions: 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

• Registration Number: NCT05238662
• Lead Sponsor: Zagazig University

Brief 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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-14
• Last Update Posted: 2022-02-14
• Study Start: 2022-03-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	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
Group B	pedicle screw fixation and interbody cage on the same side	pedicle screw fixation and interbody cage on the same side

Primary Outcome Measures

Name	Time	Method
Evaluation of fusion status	up to 3 months	Evaluation of fusion status using CT scan and Xray

Secondary Outcome Measures

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