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

Status unconfirmed

Conditions studied: Scoliosis, Back Pain

In brief

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..

Key facts

Study ID

NCT02659722

Run by

Vertebral Technologies, Inc.

People needed

200

Starts

2014-01-01

Expected to finish

2019-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• The patient has documented conservative (non-operative) treatment for at least 6 months.
• 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.
• The patient is willing and able to comply with study requirements. 7. The patient has agreed to participate in the study

You may not qualify if…

• 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.
• 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.
• The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
• 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).
• The patient has an active infection. 7. The patient is pregnant or is planning on becoming pregnant in the next two years.
• The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
• The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum.
• The patient is currently enrolled in an investigational spine study. 11. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
• The patient has symptomatic fibrous arachroiditis.

Where it is running

• SUNY Upstate — Syracuse, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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