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

• Conditions: Scoliosis; Back Pain

• Registration Number: NCT02659722
• Lead Sponsor: 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..

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02
• Primary Completion: 2018-06
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

  4. 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).

  5. The patient has an active infection. 7. The patient is pregnant or is planning on becoming pregnant in the next two years.

  6. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.

  7. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum.

  8. The patient is currently enrolled in an investigational spine study. 11. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.

  9. The patient has symptomatic fibrous arachroiditis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lordosis	24 months	retention of restored degree of lordosis
Fusion	24 months	Speed of fusion
disc height retention	24 months	loss of restored disc height over time
Complications	24 months	Migration, subsidence, hardware lossening and others

Secondary Outcome Measures

Name	Time	Method
Pain and function Scores	24 months	Visual Analog Scale (VAS) leg and back (at rest and active)
Scoliosis Research Society (SRS) Scores	24 months	Scoliosis Research Society Scores
Complications II	24 months	re-admission rate and re-operation rate

Trial Locations

Locations (1)

SUNY Upstate; 🇺🇸 Syracuse, New York, United States