Degenerative Lumbar Spine DiseasesNCT06540274
Outcomes of Surgery for Degenerative Lumbar Spine Diseases
An observational study of Degenerative Lumbar Spine Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the effectiveness of surgery on the elderly patients with DSD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Degenerative Lumbar Spine Diseases
- What is being tested?
- lumbar surgery
- Type of treatment
- Surgery or procedure
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 30 Apr 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: The study on the elderly patients of both genders with degenerative lumbar spine diseases.
Who may be able to join
- 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.
Who cannot join
- Patients having malignancy, vertebral fractures, trauma, inflammatory illnesses, and infection.
- Patients with degenerative conditions in the cervical and /or thoracic spine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mahmoud
Asyut
Khaled Hassan, Prof, +20 100 536 3318, khaledhyounes@yahoo.com
Essam Elmorshidy, 01119343404, Esmorshidy@aun.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Lumbar Spine Diseases
- Being tested
- lumbar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar surgeryProcedure or surgery
Discectomy, lumbar fusion or laminectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spine DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Zaki Morsi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540274
- Sponsor's protocol ID
- Lumbar spine surgery in elders
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Complications of Surgery for Degenerative Lumbar Spine Diseases in Elderly Patients Above 65 Years.
- ClinicalTrials.gov ID
- NCT06540274
- Acronym / sponsor ID
- Lumbar spine surgery in elders
- Conditions
- Degenerative Lumbar Spine Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- The study on the elderly patients of both genders with degenerative lumbar spine diseases.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients having malignancy, vertebral fractures, trauma, inflammatory illnesses, and infection.
- Patients with degenerative conditions in the cervical and /or thoracic spine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar surgeryDiscectomy, lumbar fusion or laminectomy | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Oswestry Disability Index.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spine Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud zaki, Master (201015695687, Mahmoud.Zaki@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS). (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.