Clinical trial NCT02659722: InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Back Pain
Keywords: INTERVERTEBRAL DISC DEGENERATION
Bone Disease
Musculoskeletal disease
Spinal disease
Lead sponsor: Vertebral Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: disc height retention
timeFrame: 24 months
measure: Complications
timeFrame: 24 months
measure: Lordosis
timeFrame: 24 months
measure: Fusion
timeFrame: 24 months
Secondary outcomes:
measure: Pain and function Scores
timeFrame: 24 months
measure: Scoliosis Research Society (SRS) Scores
timeFrame: 24 months
measure: Complications II
timeFrame: 24 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate
state: New York
Study officials:
affiliation: SUNY Unpstate
name: William Lavelle, MD
role: PRINCIPAL_INVESTIGATOR
References: