NCT06540274

Brief Summary

The purpose of this study is to determine the effectiveness of surgery on the elderly patients with DSD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

June 10, 2024

Last Update Submit

August 5, 2024

Conditions

Degenerative Lumbar Spine Diseases

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS).

    Subjective measurement for back and leg pain.The highest degree which consider worse is 8-10 and the degree which consider better is 0-3

    baseline

Secondary Outcomes (1)

  • Oswestry Disability Index.

    baseline

Interventions

lumbar surgeryPROCEDURE

Discectomy, lumbar fusion or laminectomy

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study on the elderly patients of both genders with degenerative lumbar spine diseases.

You may qualify if:

  • Patients of both genders with age above 65 years with Low Back Pain and disability.
  • Pt with clinical diagnosis of degenerative lumbar spine disease.
  • Pt with MRI showing Degenerative lumbar spine disease need surgical intervention.

You may not qualify if:

  • Patients having malignancy, vertebral fractures, trauma, inflammatory illnesses, and infection.
  • Patients with degenerative conditions in the cervical and /or thoracic spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud

Asyut, Egypt

Location

Central Study Contacts

Mahmoud zaki, Master

CONTACT

201015695687Mahmoud.Zaki@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 10, 2024

First Posted

August 6, 2024

Study Start

August 15, 2024

Primary Completion

May 1, 2025

Study Completion

April 30, 2026

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

EG(1)