Outcomes of Surgery for Degenerative Lumbar Spine Diseases

August 5, 2024 updated by: Mahmoud Mohammed Zaki Morsi, Assiut University

Outcomes and Complications of Surgery for Degenerative Lumbar Spine Diseases in Elderly Patients Above 65 Years.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS).
Time Frame: baseline
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lumbar spine surgery in elders

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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