Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
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|ClinicalTrials.gov Identifier: NCT01455805|
Recruitment Status : Recruiting
First Posted : October 20, 2011
Last Update Posted : October 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis Spondylolisthesis Degenerative Disc Disease||Device: Minuteman Fusion Implant Procedure: surgical decompression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Minuteman Fusion Implant
Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011
Device: Minuteman 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.
Other Name: The Minuteman™ interspinous interlaminar fusion device
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
- Change from baseline of clinical efficacy up to 60 months post procedure [ Time Frame: 8 weeks and up to 60 months post procedure. ]
- 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.
- measures of quality of life [ Time Frame: 8 weeks and up to 60 months post procedure. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455805
|Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital||Recruiting|
|Taunton, Somerset, United Kingdom, TA1 5DA|
|Principal Investigator: Ashok Subramanian|
|The Ipswich Hospital NHS Trust||Active, not recruiting|
|Ipswich, Suffolk, United Kingdom, IP4 5PD|
|Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS14 6UH|
|Principal Investigator: Ganesan Baranidharan|
|Sub-Investigator: Almas Kahn|
|The Dudley Group NHS Foundation Trust, Russell Hall Hospital||Recruiting|
|Birmingham, United Kingdom, DY1 2HQ|
|Principal Investigator: Mushtaq Ahmed|
|Principal Investigator:||Ganesan Baranidharan, Dr||Leeds Teaching Hospitals NHS Trust|