Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

Sponsor
Spine and Scoliosis Research Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT05536453
Collaborator
(none)
5,000
4
24
1250
52

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Lumbar Interbody Fusion Devices

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence
Actual Study Start Date :
Aug 16, 2022
Anticipated Primary Completion Date :
Aug 16, 2023
Anticipated Study Completion Date :
Aug 16, 2024

Outcome Measures

Primary Outcome Measures

  1. Incidence of Subsidence [24 months]

    Radiographic subsidence immediately postoperatively (first erect), at 12 months, and at 24 months as evaluated by an independent reviewer. Where subsidence is defined as ≥ 2mm cage penetration of the cephalad, caudal end plate, or both. Intraoperative subsidence will be classified when fluoroscopic images identify end plate violation, and postoperative subsidence is classified by the absence of violation on intraoperative fluoroscopy, but present on 12-month lateral radiographs and/or 24 months.

Secondary Outcome Measures

  1. Incidence of Fusion [24 months]

    Radiographic fusion at 12 months and at 24 months follow-up, as evaluated by up to 3 independent reviewers (2 primary reviewers and 1 adjudicator, as needed for disagreements). Fusion status will be determined according to the Bridwell-Lenke grading system (Bridwell et al. 1995), with grades 1-2 accepted as "Fused" and grades 3-4 accepted as "Not Fused." For subjects determined to be fused at 12 months, additional X-rays will not be required at 24 months unless the treating surgeon determines that radiographs are otherwise needed for the patient. The last-observation-carried-forward (LOCF) approach will be employed for 24-month fusion assessments where additional radiographs were not collected beyond 12 months.

  2. Incidence of End Plate Violation [12 months]

    Incidence of end plate violation determined based upon operative reports and medical records.

  3. Visual Analog Scale (VAS) Scores for Leg Pain, if available [24 months]

    Comparison of VAS scores for leg pain between baseline and 12 months post-operatively and baseline and 24 months post-operatively. The scores range from 0 to 100, with higher numbers indicating more pain.

  4. VAS Scores for Back Pain, if available [24 months]

    Comparison of VAS scores for back pain between baseline and 12 months post-operatively and baseline and 24 months post-operatively. The scores range from 0 to 100, with higher numbers indicating more pain.

  5. Oswestry Disability Index (ODI) Scores, if available [24 months]

    Comparison of ODI scores between baseline and 12 months post-operatively and baseline and 24 months post-operatively. The scores range from 0 to 100, with higher numbers indicating more disability.

  6. Incidence of Device and/or Procedure-Related Adverse Events [24 months]

    Incidence of device and/or procedure-related adverse events determined based upon operative reports and medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  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

Exclusion Criteria:
  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94143
2 New York University Langone Health New York New York United States 10016
3 Carolina NeuroSurgery & Spine Associates Charlotte North Carolina United States 28204
4 Rothman Orthopaedic Institute Bensalem Pennsylvania United States 19020

Sponsors and Collaborators

  • Spine and Scoliosis Research Associates

Investigators

  • Principal Investigator: Aaron Buckland, MD, SSRA Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spine and Scoliosis Research Associates
ClinicalTrials.gov Identifier:
NCT05536453
Other Study ID Numbers:
  • CP-000003
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022