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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-01-01

Brief Summary

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● 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.

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Detailed Description

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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

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

pedicle screw fixation and interbody cage on the same side

Intervention Type PROCEDURE

pedicle screw fixation and interbody cage on the same side

Interventions

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

Intervention Type PROCEDURE

pedicle screw fixation and interbody cage on the same side

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No