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NCT05238662 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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