- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659722
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
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.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jeff Felt, MD
- Phone Number: 612-708-4838
- Email: jfelt@vti-spine.com
Study Contact Backup
- Name: Ben A. Wasscher, MBA
- Phone Number: 763-218-4311
- Email: bwasscher@vti-spine.com
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Recruiting
- SUNY Upstate
-
Contact:
- Tina Craig, CCRP
- Phone Number: 315-464-8618
- Email: craigt@upstate.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disc height retention
Time Frame: 24 months
|
loss of restored disc height over time
|
24 months
|
Complications
Time Frame: 24 months
|
Migration, subsidence, hardware lossening and others
|
24 months
|
Lordosis
Time Frame: 24 months
|
retention of restored degree of lordosis
|
24 months
|
Fusion
Time Frame: 24 months
|
Speed of fusion
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain and function Scores
Time Frame: 24 months
|
Visual Analog Scale (VAS) leg and back (at rest and active)
|
24 months
|
Scoliosis Research Society (SRS) Scores
Time Frame: 24 months
|
Scoliosis Research Society Scores
|
24 months
|
Complications II
Time Frame: 24 months
|
re-admission rate and re-operation rate
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Lavelle, MD, SUNY Unpstate
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTI-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Marco LoggiaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruitingLow Back Pain | Pain, Chronic | Back Pain Lower Back Chronic | Back Pain With Radiation | Back Pain Without Radiation | Back AcheUnited States
-
Carilion ClinicVirginia Center for Health InnovationEnrolling by invitationBack Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Canandaigua VA Medical CenterFoot Levelers, Inc.; Northeast College of Health SciencesTerminatedBack Pain Lower Back ChronicUnited States
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
-
Vanderbilt University Medical CenterWithdrawnBack Pain, Low | Back Pain Without RadiationUnited States
Clinical Trials on InterFuse
-
Vertebral Technologies, Inc.Unknown