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Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

Primary Purpose

Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Minuteman Fusion Implant
surgical decompression
Sponsored by
Spinal Simplicity LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital
  • The Ipswich Hospital NHS Trust
  • Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust
  • The Dudley Group NHS Foundation Trust, Russell Hall Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Minuteman Fusion Implant

Surgical decompression

Arm Description

Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011

Surgical decompression refers to the following operations Laminectomy, Foraminotomy, Discectomy or any other surgical procedure that the clinician feels is relevant for the decompression of lumbar spinal stenosis.

Outcomes

Primary Outcome Measures

Change from baseline of clinical efficacy up to 60 months post procedure
These include: Visual Analogue Scale (VAS) pain scores Leg Pain Visual Analogue Scale (VAS) pain scores Back Pain Oswestry Disability Index (ODI) Zurich Claudication Questionnaire (ZCQ) Assessment of Physical Function via distance walked in 5 minutes and number of repetitions of sitting to standing in 1 minute. The main outcome will be a comparison between treatment groups based on the change from baseline at each follow-up visit for each of the measures listed above.

Secondary Outcome Measures

measures of quality of life
These include: Change in functional status questionnaire from baseline Participants global impression of change from baseline (PGIC) Clinician's global Impression of change from baseline (CGIC) Employment status
Adverse events related to device and procedure

Full Information

First Posted
October 13, 2011
Last Updated
May 5, 2022
Sponsor
Spinal Simplicity LLC
Collaborators
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01455805
Brief Title
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Official Title
Efficacy and Quality of Life Following Treatment of Lumbar Spinal Stenosis, Spondylolisthesis or Degenerative Disc Disease With the Minuteman Interspinous Interlaminar Fusion Implant Versus Surgical Decompression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinal Simplicity LLC
Collaborators
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 the spinal nerves.There are several treatment options for LSS including physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy, Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from May 2011 Minuteman™. Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue allowing more room for the nerves. The operation is usually preformed under general anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™ implant is preformed as a day case under local or general anaesthetic and involves implanting the device into the space between two back bones to relieve pressure on the nerves and, therefore, pain in the legs. This is a multi centred (four sites) randomised controlled trial with a total sample of 50 participants after obtaining their informed consent. Participants will attend the pain clinic at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation arrangements will be made for the participant to receive the randomised treatment. If allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist identified at the site. If allocated to surgical decompression, the treatment will be conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed up regularly for 60 months post implant to assess clinical efficacy, safety, participants function and quality of life of each treatment.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minuteman Fusion Implant
Arm Type
Active Comparator
Arm Description
Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011
Arm Title
Surgical decompression
Arm Type
Other
Arm Description
Surgical decompression refers to the following operations Laminectomy, Foraminotomy, Discectomy or any other surgical procedure that the clinician feels is relevant for the decompression of lumbar spinal stenosis.
Intervention Type
Device
Intervention Name(s)
Minuteman Fusion Implant
Other Intervention Name(s)
The Minuteman™ interspinous interlaminar fusion device
Intervention Description
The Minuteman™ interspinous interlaminar fusion device consists of a central threaded portion that has a two-part wing plate hinged near its proximal end, with spikes on the extended distal end of the wing plate, and a multi-spiked end cap plate that is located at the distal end of the device and is retained and tightened in place with a locking hex nut. Compression between the spiked wing plate and the spiked end cap plate serves to fix the spinous processes in place and to facilitate fusion, together with bone graft fusion material placed within the device. The threaded external body has been designed to provide ease of distraction and insertion via a minimally invasive surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
surgical decompression
Intervention Description
Surgical decompression refers to the following operations Laminectomy, Foraminotomy, Discectomy or any other surgical procedure that the clinician feels is relevant for the decompression of lumbar spinal stenosis
Primary Outcome Measure Information:
Title
Change from baseline of clinical efficacy up to 60 months post procedure
Description
These include: Visual Analogue Scale (VAS) pain scores Leg Pain Visual Analogue Scale (VAS) pain scores Back Pain Oswestry Disability Index (ODI) Zurich Claudication Questionnaire (ZCQ) Assessment of Physical Function via distance walked in 5 minutes and number of repetitions of sitting to standing in 1 minute. The main outcome will be a comparison between treatment groups based on the change from baseline at each follow-up visit for each of the measures listed above.
Time Frame
8 weeks and up to 60 months post procedure.
Secondary Outcome Measure Information:
Title
measures of quality of life
Description
These include: Change in functional status questionnaire from baseline Participants global impression of change from baseline (PGIC) Clinician's global Impression of change from baseline (CGIC) Employment status
Time Frame
8 weeks and up to 60 months post procedure.
Title
Adverse events related to device and procedure
Time Frame
safety to be assessed at 8 weeks and up to 60 months post procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ganesan Baranidharan, Dr
Organizational Affiliation
Leeds Teaching Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
The Ipswich Hospital NHS Trust
City
Ipswich
State/Province
Suffolk
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS14 6UH
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust, Russell Hall Hospital
City
Birmingham
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom

12. IPD Sharing Statement

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Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

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