Recruiting

InterFuse® S & T

Sponsor:

Vertebral Technologies, Inc.

Code:

NCT02659722

Conditions

Scoliosis

Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

InterFuse

Study Details

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..

Conditions

Scoliosis

Back Pain

Study ID

NCT02659722

Start date

Jan, 2014

Status verified date

Nov, 2016

Completion date

Jan, 2019

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

InterFuse

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

Primary outcome measure

  • disc height retention [ Time Frame: 24 months ]
  • Complications [ Time Frame: 24 months ]
  • Lordosis [ Time Frame: 24 months ]
  • Fusion [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

SUNY Upstate

Recruiting

Syracuse, New York, United States, 13210

Contacts

More Information

Sponsor

Vertebral Technologies, Inc.

Last update posted

Nov 2, 2016

Last verified

Nov, 2016

Keywords

  • INTERVERTEBRAL DISC DEGENERATION
  • Bone Disease
  • Musculoskeletal disease
  • Spinal disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vertebral Technologies, Inc. on 2016-11-02.