NCT05238662

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

February 7, 2022

Last Update Submit

February 7, 2022

Conditions

Treatment

Outcome Measures

Primary Outcomes (1)

  • Evaluation of fusion status

    Evaluation of fusion status using CT scan and Xray

    up to 3 months

Secondary Outcomes (1)

  • Back Pain

    At 24 hours, 2 weeks and 3 months after surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

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

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

Interventions

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

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

Group A
pedicle screw fixation and interbody cage on the same sidePROCEDURE

pedicle screw fixation and interbody cage on the same side

Group B

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wael Elmesallamy, M.D

    Zagazig University, Faculty of human medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wael Elmesallamy, M.D

CONTACT

01142453993waelmesallamy50@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 14, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

February 14, 2022

Record last verified: 2022-02