Lumbar Spinal StenosisNCT01455805
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
A study testing Minuteman Fusion Implant and surgical decompression in people with Lumbar Spinal Stenosis and Spondylolisthesis, run by Spinal Simplicity LLC at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- What is being tested?
- Minuteman Fusion Implant and surgical decompression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jun 2012to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
The Dudley Group NHS Foundation Trust, Russell Hall Hospital
Birmingham, DY1 2HQ
The Ipswich Hospital NHS Trust
Ipswich, Suffolk, IP4 5PD
Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS14 6UH
Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
About this study
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
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.
Read the 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.
- Being tested
- Minuteman Fusion Implant, surgical decompression
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minuteman Fusion ImplantDevice
Also called The Minuteman™ interspinous interlaminar fusion device
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.
surgical decompressionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Minuteman Fusion Implant | Active comparator | Minuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011 Receives: Device: Minuteman Fusion Implant |
| Surgical decompression | Other | 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. Receives: Procedure: surgical decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks and up to 60 months post procedure.
Secondary outcomes (2)
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
Measured: 8 weeks and up to 60 months post procedure.
Adverse events related to device and procedure
Measured: safety to be assessed at 8 weeks and up to 60 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJun 2012
- Primary completionMar 2024
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Simplicity LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ganesan Baranidharan, Dr, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455805
- Sponsor's protocol ID
- SS2011UK
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2011
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01455805
- Acronym / sponsor ID
- SS2011UK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Spinal Simplicity LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- Jun 2012
- Primary completion
- Mar 2024 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minuteman Fusion Implant | Active comparator | Device: Minuteman Fusion ImplantMinuteman™ interspinous interlaminar fusion Implant (interspinous interlaminar fusion device) which gained CE Mark approval in May 2011 |
| Surgical decompression | Other | Procedure: surgical decompressionSurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minuteman Fusion ImplantAlso: The Minuteman™ interspinous interlaminar fusion deviceThe 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. | Device | Minuteman Fusion Implant |
| surgical decompressionSurgical 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 or surgery | Surgical decompression |
Primary outcome
Change from baseline of clinical efficacy up to 60 months post procedure
Time frame: 8 weeks and 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.
2 secondary outcomes
measures of quality of life
Time frame: 8 weeks and up to 60 months post procedure.
Adverse events related to device and procedure
Time frame: safety to be assessed at 8 weeks and up to 60 months post procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesan Baranidharan, Dr principal investigator
Leeds Teaching Hospitals NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minuteman Fusion Implant and surgical decompression in people with Lumbar Spinal Stenosis and Spondylolisthesis, run by Spinal Simplicity LLC at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of clinical efficacy up to 60 months post procedure (time frame: 8 weeks and up to 60 months post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.