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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05238662

Enrollment

Registered

2022-02-14

Start date

2022-03-01

Completion date

2023-01-01

Last updated

2022-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment

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.

Interventions

PROCEDUREpedicle 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

PROCEDUREpedicle screw fixation and interbody cage on the same side

pedicle screw fixation and interbody cage on the same side

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of fusion status	up to 3 months	Evaluation of fusion status using CT scan and Xray

Secondary

Measure	Time frame	Description
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)

Contacts

Primary ContactWael Elmesallamy, M.D

waelmesallamy50@gmail.com01142453993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026