Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Spinal Simplicity LLC
Sponsor:
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Spinal Simplicity LLC
ClinicalTrials.gov Identifier:
NCT01455805
First received: October 13, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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 (five sites) randomised controlled trial with a total sample of 180 participants (36 from each site) 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.


Condition Intervention Phase
Lumbar Spinal Stenosis
Spondylolisthesis
Degenerative Disc Disease
Device: Minuteman Interspinous Interlaminar Fusion Implant
Procedure: surgical decompression
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:A Prospective Randomised Trial

Resource links provided by NLM:


Further study details as provided by Spinal Simplicity LLC:

Primary Outcome Measures:
  • Change from baseline of clinical efficacy up to 60 months post procedure [ Time Frame: 8 weeks and up to 60 months post procedure. ] [ Designated as safety issue: No ]

    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 [ Time Frame: 8 weeks and up to 60 months post procedure. ] [ Designated as safety issue: No ]

    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 [ Time Frame: safety to be assessed at 8 weeks and up to 60 months post procedure. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: interspinous distraction
Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011
Device: Minuteman Interspinous Interlaminar Fusion Implant

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. The assembled device can easily be placed under fluoroscopy, using a dedicated insertion tool, into the lumbar-sacral spine (L1-S1) through a one-inch lateral incision.

Other Name: Minuteman
Surgical decompression
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.
Procedure: surgical decompression
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 6 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455805

Contacts
Contact: Helen Radford helen.radford@leedsth.nhs.uk
Contact: Suzanne Rogerson suzanne.rogerson@leedsth.nhs.uk

Locations
United Kingdom
The James Cook University Hospital Not yet recruiting
Middlesbrough, South Tees, United Kingdom, TS4 3BW
Contact: helen Radford       helen.radford@leedsth.nhs.uk   
Principal Investigator: ASHISH GULVE         
Sub-Investigator: Waleed Hekal         
The Ipswich Hospital NHS Trust Not yet recruiting
Ipswich, Suffolk, United Kingdom, IP4 5PD
Contact: Helen Radford       helen.radford@leedsth.nhs.uk   
Principal Investigator: David Cumming         
Sub-Investigator: David Sharp         
Pallium Research Group, Pain Management Dept Seacroft Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS14 6UH
Contact: Helen Radford       helen.radford@leedsth.nhs.uk   
Principal Investigator: Ganesan Baranidharan, DR         
Sub-Investigator: Jake Timothy, Dr         
St Thomas' Hospital Not yet recruiting
London, United Kingdom, SE1 7EH
Contact: helen radford       helen.radford@leedsth.nhs.uk   
Principal Investigator: Stefano Palmisani         
Northampton General Hospital NHS Trust Not yet recruiting
Northampton, United Kingdom, NN1 5BD
Contact: helen Radford       helen.radford@leedsth.nhs.uk   
Principal Investigator: Partha Basu         
Sub-Investigator: Robertson-Smith         
Sponsors and Collaborators
Spinal Simplicity LLC
The Leeds Teaching Hospitals NHS Trust
Investigators
Principal Investigator: Ganesan Baranidharan, Dr Leeds Teaching Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Spinal Simplicity LLC
ClinicalTrials.gov Identifier: NCT01455805     History of Changes
Other Study ID Numbers: SS2011UK
Study First Received: October 13, 2011
Last Updated: June 22, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Constriction, Pathologic
Intervertebral Disc Degeneration
Spinal Stenosis
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on October 21, 2014