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

NCT02659722 | Unknown DMC

• 1 other identifier: VTI-012
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• disc height retention

  loss of restored disc height over time

  24 months

• Complications

  Migration, subsidence, hardware lossening and others

  24 months

• Lordosis

  retention of restored degree of lordosis

  24 months

• Fusion

  Speed of fusion

  24 months

Secondary Outcomes (3)

• Pain and function Scores

  24 months

• Scoliosis Research Society (SRS) Scores

  24 months

• Complications II

  24 months

Interventions

InterFuse DEVICE

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

Also known as: InterFuse S, InterFuse T, Modular Lumbar Interbody Fusion, Expandable cage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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:

• \. 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.

Sponsors & Collaborators

• Vertebral Technologies, Inc.: lead

Study Sites (1)

SUNY Upstate

Syracuse, New York, 13210, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis; Back Pain; Intervertebral Disc Degeneration; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Condition Hierarchy (Ancestors)

Spinal Curvatures; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Lavelle, MD

  SUNY Unpstate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Felt, MD

CONTACT

612-708-4838; jfelt@vti-spine.com

Ben A. Wasscher, MBA

CONTACT

763-218-4311; bwasscher@vti-spine.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)