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

Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659722
• Other study ID #: VTI-012
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2016
• Last updated: November 1, 2016
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: November 2016
• Source: Vertebral Technologies, Inc.
• Contact: Jeff Felt, MD
• Phone: 612-708-4838
• Email: jfelt[@]vti-spine.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration
• Scoliosis
• Spondylolisthesis

Intervention

Device:
• InterFuse
TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation

Locations

Country	Name	City	State
United States	SUNY Upstate	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vertebral Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disc height retention	loss of restored disc height over time	24 months	No
Primary	Complications	Migration, subsidence, hardware lossening and others	24 months	No
Primary	Lordosis	retention of restored degree of lordosis	24 months	No
Primary	Fusion	Speed of fusion	24 months	No
Secondary	Pain and function Scores	Visual Analog Scale (VAS) leg and back (at rest and active)	24 months	No
Secondary	Scoliosis Research Society (SRS) Scores	Scoliosis Research Society Scores	24 months	No
Secondary	Complications II	re-admission rate and re-operation rate	24 months	No