MedTrace Logo

Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

NCT05536453 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 465

Last updated 2025-10-17

No results posted yet for this study

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

Conditions

  • Degenerative Disc Disease (DDD)

Interventions

DEVICE

Lumbar Interbody Fusion Devices

Posterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease

Sponsors & Collaborators

  • Spine and Scoliosis Research Associates

    lead OTHER

Principal Investigators

  • Aaron Buckland, MD · SSRA Inc.

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2025-07-16
Completion
2025-07-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536453 on ClinicalTrials.gov