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..
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 Type
OBSERVATIONAL
Enrollment
200
TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation
SUNY Upstate
Syracuse, New York, United States
RECRUITINGdisc height retention
loss of restored disc height over time
Time frame: 24 months
Complications
Migration, subsidence, hardware lossening and others
Time frame: 24 months
Lordosis
retention of restored degree of lordosis
Time frame: 24 months
Fusion
Speed of fusion
Time frame: 24 months
Pain and function Scores
Visual Analog Scale (VAS) leg and back (at rest and active)
Time frame: 24 months
Scoliosis Research Society (SRS) Scores
Scoliosis Research Society Scores
Time frame: 24 months
Complications II
re-admission rate and re-operation rate
Time frame: 24 months
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