Outcomes of Surgery for Degenerative Lumbar Spine Diseases | NCT06540274

Studies
Outcomes of Surgery for Degenerative Lumbar Spine Diseases

NCT06540274

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Aug 6, 2024Actual

Enrollment

49Estimated

Phase

Not provided

Conditions

Degenerative Lumbar Spine Diseases

Interventions

lumbar surgery

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2024Estimated

Primary Completion Date

May 1, 2025Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Jun 10, 2024

First Submission Date that Met QC Criteria

Aug 5, 2024

First Posted Date

Aug 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2024

Last Update Posted Date

Aug 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study based on observation and follow up of elderly patients underwent for surgery for degenrtative lumbar spine diseases and the effectiveness of the surgery on the quality of their life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Estimated

Name	Type	Description	Arm Group Labels	Other Names
lumbar surgery	Procedure	Discectomy, lumbar fusion or laminectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Oswestry Disability Index.	To measure satisfaction of the patient and the functional disability. The score 0-20 consider better and the score 40-100 consider worse	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud zaki, Master	Contact	201015695687		Mahmoud.Zaki@med.aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahmoud		Asyut			Egypt	Khaled Hassan, Prof