Low Back PainPhase 4NCT02678130
A Prospective Study of the InterFuse T(tm),
A Phase 4 study testing InterFuse T in people with Low Back Pain, run by Vertebral Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- InterFuse T
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2019
- Phase
- Phase 4
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meets indications for an interbody fusion (determined by the study investigator)
- Has documented conservative (non-operative ) treatment for at least 3 months
- Has a VAS back pain of > or = 60mm
- Has an ODI > or = 40%
- at least 18 years of age and skeletally mature
- Willing and able to comply with study requirements
- Patient's condition is appropriate for surgery
- Agreed to participate in study
Who cannot join
- Has severe osteoporosis or osteopenia
- Grade 3 or higher Spondylolisthesis
- Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation
- Body Mass Index (BMI) > 40
- Patient has active infection
- Patient is pregnant or planning to become pregnant
Show all 11Show fewer
- Patient is mentally ill or has history of drug abuse
- Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum
- Patient is currently enrolled in an investigational spine study
- Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease
- patient bhas symptomatic fibrous arachnoiditis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Christine Hudson, 843-792-3790, hudsoncm@musc.edu
Michelle DeCandio, RN,OCN,CCRP, 843-792-9016, decandio@musc.edu
About this study
Official title: A Prospective Study of the InterFuse T(tm)
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
Read the detailed description
The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in [patients undergoing interbody fusion.
The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study
- Conditions
- Low Back Pain
- Being tested
- InterFuse T, Standard of Care TLIF (Stryker AVS Unilif)
- Keywords
- Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Bone Diseases, Musculoskeletal Diseases, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterFuse TDevice
Transforaminal Lumbar Interbody fusion (TLIF)
Standard of Care TLIF (Stryker AVS Unilif)Device
Transforaminal Lumbar Interbody Fusion (TLIF)
| Study group | Role | What they receive |
|---|---|---|
| InterFuse Group | Active comparator | Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device Receives: Device: InterFuse T |
| Control Group: Standard of care TLIF | Active comparator | treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif) Receives: Device: Standard of Care TLIF (Stryker AVS Unilif) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fusion rates
Assessment of the fusion rates as demonstrated by radiographic evidence.
Measured: 12 months
Secondary outcomes (4)
Visual Analog Scale (VAS)
Visual Analog Scale pre-op compared to VAS score at 2-4 weeks, 6 months and at 1 year
Measured: up to 12 months
Oswestry Disability Score (ODI)
Oswestry Low Back Pain Disability Questionaire
Measured: 12 months
SF-36
Rand 36-item Health Survey (version 1.0)
Measured: 12 months
Maintenance of disk height
comparison of disk height pre-op versus at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertebral Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen P Kallhorn, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678130
- Sponsor's protocol ID
- VTI-011
- Status last verified
- Nov 2016
- First submitted
- 22 Jan 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study
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 Prospective Study of the InterFuse T(tm)
- ClinicalTrials.gov ID
- NCT02678130
- Acronym / sponsor ID
- VTI-011
- Conditions
- Low Back Pain
- Keywords
- Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vertebral Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Feb 2016 (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 purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
Detailed description
The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in [patients undergoing interbody fusion.
The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InterFuse Group | Active comparator | Device: InterFuse TPatients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device |
| Control Group: Standard of care TLIF | Active comparator | Device: Standard of Care TLIF (Stryker AVS Unilif)treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- meets indications for an interbody fusion (determined by the study investigator)
- Has documented conservative (non-operative ) treatment for at least 3 months
- Has a VAS back pain of > or = 60mm
- Has an ODI > or = 40%
- at least 18 years of age and skeletally mature
Key exclusion criteria (11 listed)
- Has severe osteoporosis or osteopenia
- Grade 3 or higher Spondylolisthesis
- Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation
- Body Mass Index (BMI) > 40
- Patient has active infection
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 |
|---|---|---|
| InterFuse TTransforaminal Lumbar Interbody fusion (TLIF) | Device | InterFuse Group |
| Standard of Care TLIF (Stryker AVS Unilif)Transforaminal Lumbar Interbody Fusion (TLIF) | Device | Control Group: Standard of care TLIF |
Primary outcome
fusion rates
Time frame: 12 months
Assessment of the fusion rates as demonstrated by radiographic evidence.
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: up to 12 months
Oswestry Disability Score (ODI)
Time frame: 12 months
SF-36
Time frame: 12 months
Maintenance of disk height
Time frame: 12 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: Yes. It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study
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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.
Stephen P Kallhorn, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing InterFuse T in people with Low Back Pain, run by Vertebral Technologies, Inc. at 1 site in United States.
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 8 inclusion and 11 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jeff Felt, MD (612-708-4838, jfelt@vti-spine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fusion rates (time frame: 12 months). 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; AzTrials last refreshed its copy on 31 Oct 2026.