Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 180
Summary
- Conditions
- Degenerative Disc Disease
- Lumbar Spinal Stenosis
- Spondylolisthesis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective randomised study monitoring patients for up to 5 years post treatment. Only patients who have an appropriately diagnosed Lumbar Spinal Stenosis with intermittent claudication with/without low back pain, with no adequate symptomatic relief after at least 6 months of conservative...
This is a prospective randomised study monitoring patients for up to 5 years post treatment. Only patients who have an appropriately diagnosed Lumbar Spinal Stenosis with intermittent claudication with/without low back pain, with no adequate symptomatic relief after at least 6 months of conservative treatment will be asked to give consent to be involved. Potential participants will be approached for enrollment 17days before the planned baseline visit. Patients will be given oral and written information about the trial as well as the patient information leaflet for the study. If informed consent is given their participation in this study will be for a maximum of 5 years.
Tracking Information
- NCT #
- NCT01455805
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Investigators
- Principal Investigator: Ganesan Baranidharan, Dr Leeds Teaching Hospitals NHS Trust