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InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)

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ClinicalTrials.gov Identifier: NCT02659722
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Vertebral Technologies, Inc.

Brief 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. Comparisons will be made with published historical data..

Condition or disease Intervention/treatment
Scoliosis Back Pain Device: InterFuse

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 : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Study Start Date : January 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis


Intervention Details:
  • Device: InterFuse
    TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation
    Other Names:
    • InterFuse S
    • InterFuse T
    • Modular Lumbar Interbody Fusion
    • Expandable cage


Primary Outcome Measures :
  1. disc height retention [ Time Frame: 24 months ]
    loss of restored disc height over time

  2. Complications [ Time Frame: 24 months ]
    Migration, subsidence, hardware lossening and others

  3. Lordosis [ Time Frame: 24 months ]
    retention of restored degree of lordosis

  4. Fusion [ Time Frame: 24 months ]
    Speed of fusion


Secondary Outcome Measures :
  1. Pain and function Scores [ Time Frame: 24 months ]
    Visual Analog Scale (VAS) leg and back (at rest and active)

  2. Scoliosis Research Society (SRS) Scores [ Time Frame: 24 months ]
    Scoliosis Research Society Scores

  3. Complications II [ Time Frame: 24 months ]
    re-admission rate and re-operation rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659722


Contacts
Contact: Jeff Felt, MD 612-708-4838 jfelt@vti-spine.com
Contact: Ben A. Wasscher, MBA 763-218-4311 bwasscher@vti-spine.com

Locations
United States, New York
SUNY Upstate Recruiting
Syracuse, New York, United States, 13210
Contact: Tina Craig, CCRP    315-464-8618    craigt@upstate.edu   
Sponsors and Collaborators
Vertebral Technologies, Inc.
Investigators
Principal Investigator: William Lavelle, MD SUNY Unpstate

Responsible Party: Vertebral Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02659722     History of Changes
Other Study ID Numbers: VTI-012
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Presentations by investigator(s) at scientific meetings, submission of manuscript to peer reviewed journal

Keywords provided by Vertebral Technologies, Inc.:
INTERVERTEBRAL DISC DEGENERATION
Bone Disease
Musculoskeletal disease
Spinal disease

Additional relevant MeSH terms:
Back Pain
Scoliosis
Intervertebral Disc Degeneration
Spondylolisthesis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis