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

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05238662
• Other study ID #: 9181
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2022
• Source: Zagazig University
• Contact: Wael Elmesallamy, M.D
• Phone: 01142453993
• Email: waelmesallamy50[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Treatment

Intervention

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
• pedicle screw fixation and interbody cage on the same side
pedicle screw fixation and interbody cage on the same side

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of fusion status	Evaluation of fusion status using CT scan and Xray	up to 3 months
Secondary	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