TreatmentNCT05238662
Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage
A study testing pedicle screw fixation on one side and intervertebral cage on the other sided and pedicle screw fixation and interbody cage on the same side in people with Treatment, run by Zagazig University.
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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Treatment
- What is being tested?
- pedicle screw fixation on one side and intervertebral cage on the other sided and pedicle screw fixation and interbody cage on the same side
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patient refusal.
- Altered mental status.
- Patients with associated comorbidity interfere with surgery.
- Extremes of age.
- Multiple level lumbar degenerative disease
- Trauma
Show all 9Show fewer
- Spinal tumour
- Active infection
- Previous lumbar operation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion
● 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.
Read the 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.
- Conditions
- Treatment
- Being tested
- pedicle screw fixation on one side and intervertebral cage on the other sided, pedicle screw fixation and interbody cage on the same side
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedicle screw fixation on one side and intervertebral cage on the other sidedProcedure or surgery
pedicle screw fixation on one side and intervertebral cage on the other sided
pedicle screw fixation and interbody cage on the same sideProcedure or surgery
pedicle screw fixation and interbody cage on the same side
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | pedicle screw fixation on one side and intervertebral cage on the other sided Receives: Procedure: pedicle screw fixation on one side and intervertebral cage on the other sided |
| Group B | Active comparator | pedicle screw fixation and interbody cage on the same side Receives: Procedure: pedicle screw fixation and interbody cage on the same side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of fusion status
Evaluation of fusion status using CT scan and Xray
Measured: up to 3 months
Secondary outcomes (1)
Back Pain
use of Visual Analogue Scale (VAS) as a 10-cm line labeled with (0= no pain and 10=worst pain)
Measured: At 24 hours, 2 weeks and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, wael Abdelrahman Elmesallamy, Zagazig University
- Investigators
- Wael Elmesallamy, M.D, Principal investigator, Zagazig University, Faculty of human medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238662
- Sponsor's protocol ID
- 9181
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique for Degenerative Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage Fusion
- ClinicalTrials.gov ID
- NCT05238662
- Acronym / sponsor ID
- 9181
- Conditions
- Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
● 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: pedicle screw fixation on one side and intervertebral cage on the other sidedpedicle screw fixation on one side and intervertebral cage on the other sided |
| Group B | Active comparator | Procedure: pedicle screw fixation and interbody cage on the same sidepedicle screw fixation and interbody cage on the same side |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Patient refusal.
- Altered mental status.
- Patients with associated comorbidity interfere with surgery.
- Extremes of age.
- Multiple level lumbar degenerative disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedicle screw fixation on one side and intervertebral cage on the other sidedpedicle screw fixation on one side and intervertebral cage on the other sided | Procedure or surgery | Group A |
| pedicle screw fixation and interbody cage on the same sidepedicle screw fixation and interbody cage on the same side | Procedure or surgery | Group B |
Primary outcome
Evaluation of fusion status
Time frame: up to 3 months
Evaluation of fusion status using CT scan and Xray
1 secondary outcome
Back Pain
Time frame: At 24 hours, 2 weeks and 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Elmesallamy, M.D principal investigator
Zagazig University, Faculty of human medicine
Questions about this trial
What is this clinical trial studying?
A study testing pedicle screw fixation on one side and intervertebral cage on the other sided and pedicle screw fixation and interbody cage on the same side in people with Treatment, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wael Elmesallamy, M.D (01142453993 ext. 002, waelmesallamy50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of fusion status (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.