NCT06722859

Brief Summary

To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

Study Start

First participant enrolled

December 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 4, 2024

Last Update Submit

December 4, 2024

Conditions

Degenerative Lumbar Canal Stenosis

Outcome Measures

Primary Outcomes (1)

  • Clincal evaluation by visual analogue scale back pain and leg pain

    12 months

Study Arms (2)

Open surgical decompression

OTHER
Procedure: Open surgical decompression in degenerative lumbar canal stenosisProcedure: Microsurgical decompression

Microsurgical decompression

OTHER
Procedure: Open surgical decompression in degenerative lumbar canal stenosisProcedure: Microsurgical decompression

Interventions

Open surgical decompression in degenerative lumbar canal stenosisPROCEDURE

Open surgical decompression in degenerative lumbar canal stenosis

Microsurgical decompressionOpen surgical decompression
Microsurgical decompressionPROCEDURE

Microsurgical decompression of degenerative lumbar canal stenosis

Microsurgical decompressionOpen surgical decompression

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients present with degenerative lumber spinal canal stenosis in one or two level

You may not qualify if:

  • degenrative listhesis.
  • degenerative scoliosis.
  • other secondary causes of lumber canal stenosis as tumor , abscesses and infection.
  • Patients with previous lumbar operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Shamel Mahmoud Mohamed, Resident

CONTACT

01028174272shamel.15259250@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of orthopedic and trauma surgery Assiut university hospital

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

December 1, 2024

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12