ScoliosisNCT02659722
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
An observational study of Scoliosis and Back Pain, run by Vertebral Technologies, Inc. at 1 site in United States.
Trial summary
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- InterFuse
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) and/or scoliosis and a planned fusion of at least five levels.. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
Who may be able to join
- 1. The patients has a planned fusion construct of at least five levels and will have the InterFuse (S) or (T) planned for L5-S1 and/or L4-L5.
- 2. The patient has documented conservative (non-operative) treatment for at least 6 months.
- 3. The patient has a VAS score of ≥ 60 mm for Back and/or Leg. 4. The patient has an ODI ≥ 40%. 5. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
- 6. The patient is willing and able to comply with study requirements. 7. The patient has agreed to participate in the study
Who cannot join
- 1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). Previous non-fusion surgery at the proposed treatment level(s) is acceptable.
- 2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
- 3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
- 4. The patient has known neoplastic disease other than skin cancer. 5. The patient has a Body Mass Index (BMI) of greater than 40; BMI = wt (kg)/ht2 (m2).
- 6. The patient has an active infection. 7. The patient is pregnant or is planning on becoming pregnant in the next two years.
- 8. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
Show all 9Show fewer
- 9. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum.
- 10. The patient is currently enrolled in an investigational spine study. 11. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
- 12. The patient has symptomatic fibrous arachroiditis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SUNY Upstate
Syracuse, New York, 13210
Tina Craig, CCRP, 315-464-8618, craigt@upstate.edu
About this study
Official title: A Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse® S and InterFuse® T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease.
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..
Read the detailed description
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. While there is no concurrent control population, there is ample historical control data to be used for comparison.
The study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System. Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in the study will be followed for at least 24 months.
- Being tested
- InterFuse
- Keywords
- INTERVERTEBRAL DISC DEGENERATION, Bone Disease, Musculoskeletal disease, Spinal disease
- Medical subject headings
- Scoliosis, 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.
InterFuseDevice
Also called InterFuse S, InterFuse T, Modular Lumbar Interbody Fusion, Expandable cage
TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
disc height retention
loss of restored disc height over time
Measured: 24 months
Complications
Migration, subsidence, hardware lossening and others
Measured: 24 months
Lordosis
retention of restored degree of lordosis
Measured: 24 months
Fusion
Speed of fusion
Measured: 24 months
Secondary outcomes (3)
Pain and function Scores
Visual Analog Scale (VAS) leg and back (at rest and active)
Measured: 24 months
Scoliosis Research Society (SRS) Scores
Scoliosis Research Society Scores
Measured: 24 months
Complications II
re-admission rate and re-operation rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2014
- 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 ScoliosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertebral Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Lavelle, MD, Principal investigator, SUNY Unpstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659722
- Sponsor's protocol ID
- VTI-012
- Status last verified
- Nov 2016
- First submitted
- 15 Jan 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Presentations by investigator(s) at scientific meetings, submission of manuscript to peer reviewed journal
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 Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse® S and InterFuse® T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease.
- ClinicalTrials.gov ID
- NCT02659722
- Acronym / sponsor ID
- VTI-012
- Keywords
- INTERVERTEBRAL DISC DEGENERATION, Bone Disease, Musculoskeletal disease, Spinal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vertebral Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Jan 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 primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..
Detailed description
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. While there is no concurrent control population, there is ample historical control data to be used for comparison.
The study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System. Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in the study will be followed for at least 24 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) and/or scoliosis and a planned fusion of at least five levels.. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
Key inclusion criteria (4 listed)
- 1. The patients has a planned fusion construct of at least five levels and will have the InterFuse (S) or (T) planned for L5-S1 and/or L4-L5.
- 2. The patient has documented conservative (non-operative) treatment for at least 6 months.
- 3. The patient has a VAS score of ≥ 60 mm for Back and/or Leg. 4. The patient has an ODI ≥ 40%. 5. The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
- 6. The patient is willing and able to comply with study requirements. 7. The patient has agreed to participate in the study
Key exclusion criteria (9 listed)
- 1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). Previous non-fusion surgery at the proposed treatment level(s) is acceptable.
- 2. The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
- 3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
- 4. The patient has known neoplastic disease other than skin cancer. 5. The patient has a Body Mass Index (BMI) of greater than 40; BMI = wt (kg)/ht2 (m2).
- 6. The patient has an active infection. 7. The patient is pregnant or is planning on becoming pregnant in the next two years.
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 |
|---|---|---|
| InterFuseAlso: InterFuse S, InterFuse T, Modular Lumbar Interbody Fusion, Expandable cageTRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation | Device | – |
Primary outcome
disc height retention
Time frame: 24 months
loss of restored disc height over time
Complications
Time frame: 24 months
Migration, subsidence, hardware lossening and others
Lordosis
Time frame: 24 months
retention of restored degree of lordosis
Fusion
Time frame: 24 months
Speed of fusion
3 secondary outcomes
Pain and function Scores
Time frame: 24 months
Scoliosis Research Society (SRS) Scores
Time frame: 24 months
Complications II
Time frame: 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: Yes. Presentations by investigator(s) at scientific meetings, submission of manuscript to peer reviewed journal
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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.
William Lavelle, MD principal investigator
SUNY Unpstate
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 Scoliosis and 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 4 inclusion and 9 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.
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?
disc height retention (time frame: 24 months). The study lists 4 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.