Summary

Eligibility
for people ages 18-110 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lee Tan, MD
Headshot of Lee Tan
Lee Tan

Description

Summary

The objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (IBFD), both expandable (EXP) and static (STC), according to their intended use and cleared labeling to understand IBFD design and technique characteristics that affect occurrence rates of subsidence. Patients treated with IBFD's (both EXP and STC) according to their intended use and cleared labeling 1. EXP IBFD's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to EXP IBFD's that expand in height only and STC IBFD's. 2. EXP IBFD's that are comprised of multi-material composition with Polyetheretherketone (PEEK) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to EXP and STC IBFD's that are primarily comprised of Ti with Ti endplate contacting surfaces. 3. achieve radiographic fusion at a rate consistent with the state-of-the-art 4. achieve significant improvements in pain and function compared to baseline 5. experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery 6. not demonstrate any intraoperative complications during the implant process 7. operative approach does not correlate with increased rates of subsidence

Official Title

A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence

Keywords

Degenerative Disc Disease (DDD) Intervertebral Disc Degeneration Lumbar Interbody Fusion Devices

Eligibility

You can join if…

Open to people ages 18-110

  1. The patient was treated with TLIF or PLIF surgery using the IBFD according to the cleared labeling, based on the surgeon's clinical judgment and patient-specific decision making. Based on the product labeling, the patient must:
  2. Was at least 18 years of age and skeletally mature at the time of surgery
  3. Had clinical and radiological evidence of DDD of the lumbar spine
  4. Undergone treatment with the IBFD with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone at 1 or 2 contiguous levels from L2 to S1

You CAN'T join if...

  1. History of fusion surgery or large laminectomy at L2 to S1 prior to treatment with the IBFD(s) Spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
  2. Surgery with the IBFD(s) at more than 2 contiguous levels
  3. Surgery with the IBFD(s) at levels outside the range of L2 to S1
  4. Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
  5. Any contraindications listed in the cleared product labeling
  6. Osteoporosis, Other Systemic Bone D.O. T score ≤ -1.5
  7. BMI > 40
  8. Systemic Infection
  9. H/O IV Drug Use
  10. . Cancer

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Carolina NeuroSurgery & Spine Associates not yet accepting patients
    Charlotte North Carolina 28204 United States

Lead Scientist at UCSF

  • Lee Tan, MD
    Dr. Lee Tan specializes in both minimally invasive and traditional open surgical techniques for the treatment of various spinal disorders.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Spine and Scoliosis Research Associates
ID
NCT05536453
Study Type
Observational
Participants
Expecting 5000 study participants
Last Updated