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

November 1, 2016 updated by: Vertebral Technologies, Inc.

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..

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William Lavelle, MD, SUNY Unpstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Presentations by investigator(s) at scientific meetings, submission of manuscript to peer reviewed journal

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.

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