Disk, HerniatedNCT01652053
A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy
An observational study of Disk, Herniated, run by Vertebral Technologies, Inc. at 1 site in Canada.
Trial summary
The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Disk, Herniated
- What is being tested?
- Disc Nucleus Replacement (InterCushion DNP)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jun 2018
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The protocol includes skeletally mature patients, both male and female, 18 to 60 years old suffering from a herniated disc (confirmed by X-ray, CT or MRI) with persistent leg pain.
Who may be able to join
- Patient has signed and dated a study specific informed consent form approved by the reviewing Institutional Review Board or Ethics Committee.
- Patient is 21 to 60 years of age.
- Patient is skeletally mature
- Patient requires a discectomy of one level from L2-S1.
- Patient has less than 50% loss of disc height at the affected level.
- Patient has persistent pain (predominantly leg pain, although some back pain that occurred at the same time as the leg pain and is believed to be associated with the disc herniation will not disqualify the patient from participating in this study) and symptoms despite a minimum of six weeks of non-operative treatment.
Show all 10Show fewer
- Patient X-ray, CT or MR evidence of a herniated disc at the affected level.
- Patient has a minimum leg pain score of 6 cm on a 10 cm (i.e. 60 mm on a 100 mm) point visual analog scale (VAS).
- Patient has a minimum Oswestry Disability Index score of 40% (based upon a 100% scale).
- Patient is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient has had any previous surgery at the affected levels.
- Patient has had any attempt at spinal fusion, at any lumbar levels.
- Patient has motion of < 3 degrees on pre-operative lateral flexion/extension radiographs
- Patient has a BMI
- Patient has severe osteoporosis of the spine.
- Patient has previously undergone chemotherapy, immunosuppressive therapy or radiation to the local area.
Show all 17Show fewer
- Patient has active local or systemic infection.
- Patient has any known active malignancy.
- Patient has rheumatoid arthritis or systemic lupus erythematosus, or other chronic, inflammatory autoimmune disorder.
- Patient has ankylosing spondylitis or other spondyloarthropathy.
- Patient has spondylolisthesis.
- Patient is pregnant or plans to become pregnant during the course of the study.
- Patient has other concurrent physical or mental conditions that are likely to affect their outcome.
- Patient has congenital stenosis
- Patient is diabetic.
- The patient has osteoporosis or severe osteopenia as determined by the Investigator. Females over 40 with bone density score less than -1. A clinical SCORE calculator may also be utilized for females over 40 years of age.
- Patient has significant facet disease.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Brandon Regional Health Center
Brandon, Manitoba, R7A 2B3
Jeff Felt, MD, 612-708-4838, jfelt@vti-spine.com
Ben A. Wasscher, MBA, 763-218-4311, bwasscher@vti-spine.com
About this study
Official title: A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy
The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or better than the historical published results for discectomy alone.
Read the detailed description
All patients will be followed for at least 24 months once enrolled in the study. Clinical evaluations will be conducted before surgery (baseline), intraoperative, 2 week (± 1 week), 6 week (± 1 week), 3 months (± 2 weeks), 6 months (± 1 month), 12 months (± 2 months) and 24 months (± 2 months).
- Conditions
- Disk, Herniated
- Being tested
- Disc Nucleus Replacement (InterCushion DNP)
- Keywords
- InterCushion
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disc Nucleus Replacement (InterCushion DNP)Device
Also called InterCushion Disc Nucleus Prosthesis (DNP)
The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1. These patients should have no spondylolisthesis at the involved level.
| Study group | Role | What they receive |
|---|---|---|
| Disc Nucleus Replacement | Disc Nucleus Replacement (InterCushion DNP) Receives: Device: Disc Nucleus Replacement (InterCushion DNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in ODI
Improvement in the Oswestry Disability Index (ODI) score i.e. decrease of 15% or better ODI.
Measured: 6 months
Decrease in VAS
Improvement in leg pain evidenced by decrease in pain score of at least 2 cm (i.e. 20 mm) on the visual analog scale (VAS)
Measured: 6 months
Maintenance of post-operative disc height
Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.
Measured: 6 months
Mobility of treated segment
Motion of ≥ 3 degrees on lateral flexion/extension radiographs
Measured: 6 months
Neurologic deficits
No new permanent neurological deficit or worsening of an existing permanent neurological deficit
Measured: 6 months
Secondary outcomes (5)
Maintenance or decrease in ODI
Maintenance of improvement or further improvement in the Oswestry Disability Index (ODI) score measured at six months i.e. decrease of 15% or better ODI.
Measured: 12 and 24 months
Maintenance or decrease in VAS
Maintenance of improvement or further improvement in leg pain evidenced by decrease in pain score on the visual analog scale (VAS)
Measured: 12 and 24 months
Maintenance of post-operative disc height.
Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.
Measured: 12 and 24 months
Mobility of treated segment
Motion of ≥ 3 degrees on lateral flexion/extension radiographs
Measured: 12 and 24 months
Neurological deficits
No new permanent neurological deficit or worsening of an existing permanent neurological deficit
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk, HerniatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertebral Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip F de Muelanaere, MD, Principal investigator, Brandon General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652053
- Sponsor's protocol ID
- CP 2010-001
- Status last verified
- Nov 2016
- First submitted
- 24 Jul 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Assess the Safety and Effectiveness of the InterCushion Disc Nucleus Prosthesis in Patients Receiving Discectomy
- ClinicalTrials.gov ID
- NCT01652053
- Acronym / sponsor ID
- CP 2010-001
- Conditions
- Disk, Herniated
- Keywords
- InterCushion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vertebral Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 Jul 2012 (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.
The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale (VAS) at six months post-surgery. It is anticipated that outcomes with the InterCushion Disc Nucleus Prosthesis (DNP) will be comparable to or better than the historical published results for discectomy alone.
Detailed description
All patients will be followed for at least 24 months once enrolled in the study. Clinical evaluations will be conducted before surgery (baseline), intraoperative, 2 week (± 1 week), 6 week (± 1 week), 3 months (± 2 weeks), 6 months (± 1 month), 12 months (± 2 months) and 24 months (± 2 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disc Nucleus Replacement | – | Device: Disc Nucleus Replacement (InterCushion DNP)Disc Nucleus Replacement (InterCushion DNP) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The protocol includes skeletally mature patients, both male and female, 18 to 60 years old suffering from a herniated disc (confirmed by X-ray, CT or MRI) with persistent leg pain.
Key inclusion criteria (10 listed)
- Patient has signed and dated a study specific informed consent form approved by the reviewing Institutional Review Board or Ethics Committee.
- Patient is 21 to 60 years of age.
- Patient is skeletally mature
- Patient requires a discectomy of one level from L2-S1.
- Patient has less than 50% loss of disc height at the affected level.
Key exclusion criteria (17 listed)
- Patient has had any previous surgery at the affected levels.
- Patient has had any attempt at spinal fusion, at any lumbar levels.
- Patient has motion of < 3 degrees on pre-operative lateral flexion/extension radiographs
- Patient has a BMI
- Patient has severe osteoporosis of the spine.
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 |
|---|---|---|
| Disc Nucleus Replacement (InterCushion DNP)Also: InterCushion Disc Nucleus Prosthesis (DNP)The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1. These patients should have no spondylolisthesis at the involved level. | Device | Disc Nucleus Replacement |
Primary outcome
Decrease in ODI
Time frame: 6 months
Improvement in the Oswestry Disability Index (ODI) score i.e. decrease of 15% or better ODI.
Decrease in VAS
Time frame: 6 months
Improvement in leg pain evidenced by decrease in pain score of at least 2 cm (i.e. 20 mm) on the visual analog scale (VAS)
Maintenance of post-operative disc height
Time frame: 6 months
Disc at the treated level is collapsed by ≤ 15% when compared to an adjacent health level.
Mobility of treated segment
Time frame: 6 months
Motion of ≥ 3 degrees on lateral flexion/extension radiographs
Neurologic deficits
Time frame: 6 months
No new permanent neurological deficit or worsening of an existing permanent neurological deficit
5 secondary outcomes
Maintenance or decrease in ODI
Time frame: 12 and 24 months
Maintenance or decrease in VAS
Time frame: 12 and 24 months
Maintenance of post-operative disc height.
Time frame: 12 and 24 months
Mobility of treated segment
Time frame: 12 and 24 months
Neurological deficits
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Disk, Herniated
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
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.
Phillip F de Muelanaere, MD principal investigator
Brandon General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disk, Herniated, run by Vertebral Technologies, Inc. at 1 site in Canada.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurie E Lynch, PhD (952-221-2468, laurie.lynch@visi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in ODI (time frame: 6 months). The study lists 5 primary outcomes in all. 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 2 Nov 2016.