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A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence
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
Age
18 - 110 years
Sex
ALL
Healthy Volunteers
No
University of California San Francisco
San Francisco, California, United States
New York University Langone Health
New York, New York, United States
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, United States
Rothman Orthopaedic Institute
Bensalem, Pennsylvania, United States
Start Date
August 16, 2022
Primary Completion Date
July 16, 2025
Completion Date
July 16, 2025
Last Updated
October 20, 2025
465
ACTUAL participants
Lumbar Interbody Fusion Devices
DEVICE
Lead Sponsor
Spine and Scoliosis Research Associates
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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