NCT04083703

Brief Summary

Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse

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
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

September 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 2, 2019

Last Update Submit

September 6, 2019

Conditions

Lumbar Disc Herniation

Keywords

Interbody Cage

Outcome Measures

Primary Outcomes (1)

  • Decrease pain after discectomy and interbody cage insertion.

    Comparison between preoperative pain with lumbar disc prolapse and posoperative pain improved after Interbody cage insertion.

    Base line

Study Arms (2)

Simple lumbar discectomy

EXPERIMENTAL
Procedure: Interbody cage insertion in lumbar disc prolapse

Lumbar discectomy with inter vertebral cage

EXPERIMENTAL
Procedure: Interbody cage insertion in lumbar disc prolapse

Interventions

Interbody cage insertion in lumbar disc prolapsePROCEDURE

Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse

Also known as: Discectomy
Lumbar discectomy with inter vertebral cageSimple lumbar discectomy

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with lumbar disc prolapse one or two levels.
  • Patients (age \>18 and \< 70 years old).
  • Patients fit for surgery.

You may not qualify if:

  • Patients with instability of lumbar spine.
  • Patients with degenerative diseases.
  • More than two levels
  • Patients \<18 or \>70 years.
  • Patients unfit for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Diskectomy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, Operative

Study Officials

  • Abdel Hai Moussa Abdel Latif, prof.

    Assiut University hospital,Neurosurgery department

    STUDY DIRECTOR

  • Ahmed Elsayed Abo Kresha, Assistant Prof.

    Assiut University hospital,Neurosurgery department

    STUDY DIRECTOR

  • Mohamed Elsayed mahmoud, Assistant Prof.

    Assiut University hospital,Neurosurgery department

    STUDY DIRECTOR

Central Study Contacts

Fahd Abdel Sabour Ahmed, Rdr

CONTACT

00201029522851fahdneuro4@outlook.com

Study Design

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

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 10, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09