- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455805
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Birmingham, United Kingdom, DY1 2HQ
- The Dudley Group NHS Foundation Trust, Russell Hall Hospital
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Somerset
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Taunton, Somerset, United Kingdom, TA1 5DA
- Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital
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Suffolk
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Ipswich, Suffolk, United Kingdom, IP4 5PD
- The Ipswich Hospital NHS Trust
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West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS14 6UH
- Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Minuteman Fusion Implant
Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011
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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.
Other Names:
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Other: 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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from baseline of clinical efficacy up to 60 months post procedure
Time Frame: 8 weeks and up to 60 months post procedure.
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These include:
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. |
8 weeks and up to 60 months post procedure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measures of quality of life
Time Frame: 8 weeks and up to 60 months post procedure.
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These include:
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8 weeks and up to 60 months post procedure.
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Adverse events related to device and procedure
Time Frame: safety to be assessed at 8 weeks and up to 60 months post procedure.
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safety to be assessed at 8 weeks and up to 60 months post procedure.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ganesan Baranidharan, Dr, Leeds Teaching Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SS2011UK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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