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

Zagazig University

Status: Unknown

Conditions: Treatment

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT05238662

9181

Details and patient eligibility

About

● 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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group A

Active Comparator group

Description:

pedicle screw fixation on one side and intervertebral cage on the other sided

Treatment:

Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided

Group B

Active Comparator group

Description:

pedicle screw fixation and interbody cage on the same side

Treatment:

Procedure: pedicle screw fixation and interbody cage on the same side