Status:
COMPLETED
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Lead Sponsor:
Spinal Simplicity LLC
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Conditions:
Lumbar Spinal Stenosis
Spondylolisthesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on th...
Detailed 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 wit...
Eligibility Criteria
Inclusion
- Is male or a non pregnant female aged 18years or older
- BMI ≤ 35kg/m2
- Has chronic leg pain with or without back pain of greater than 6 months duration,which is partially or completely relieved by either sitting or adopting a flexed posture and who are suitable in the clinicians opinion for posterior lumbar surgery
- Pre-operative ODI score ≥ 20%
- Pre-operative ZCQ Physical Function Domain ≥2
- Pre-operative VAS Leg pain score ≥ 4
- Has completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief or has worsening neurological symptoms.
- Has degenerative changes at 1 or 2 levels confirmed by MRI or CT Myelogram within the last 12 months) with one or more of the following:
- Lumbar spinal stenosis with intermittent neurogenic claudication
- Degeneration of the disc (as evidenced by imaging on MRI)
- Annular thickening
- Degenerative Spondylolisthesis ≤ Meyerding Grade 1
- Thickening of ligamentum flavum
Exclusion
- Fixed motor deficit
- Has undergone previous lumbar spinal surgery
- Is unwilling or unable to give consent or adhere to the follow up schedule
- Has active infection or metastatic disease
- Has spondylolisthesis \> grade 1
- Has neurogenic bladder or bowel disease
- Has a history of Osteopenia and or Osteoporosis. Evaluation of possible Osteopenia and or Osteoporosis will be conducted via a bone density scan prior to randomisation if ANY of the Bone Mass Evaluation criteria is met
- Patients who are not deemed fit for anaesthesia/major surgery due to underlying medical condition
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01455805
Start Date
June 1 2012
End Date
March 1 2024
Last Update
April 11 2024
Active Locations (4)
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1
Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
2
The Ipswich Hospital NHS Trust
Ipswich, Suffolk, United Kingdom, IP4 5PD
3
Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS14 6UH
4
The Dudley Group NHS Foundation Trust, Russell Hall Hospital
Birmingham, United Kingdom, DY1 2HQ