Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

NCT05536453 | Completed FDA Device

• 1 other identifier: CP-000003
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 4

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. 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. 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. 3.achieve radiographic fusion at a rate consistent with the state-of-the-art
4. 4.achieve significant improvements in pain and function compared to baseline
5. 5.experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery
6. 6.not demonstrate any intraoperative complications during the implant process
7. 7.operative approach does not correlate with increased rates of subsidence

Conditions

Degenerative Disc Disease (DDD)

Outcome Measures

Primary Outcomes (1)

• Incidence of Subsidence

  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.

  24 months

Secondary Outcomes (6)

• Incidence of Fusion

  24 months

• Incidence of End Plate Violation

  12 months

• Visual Analog Scale (VAS) Scores for Leg Pain, if available

  24 months

• VAS Scores for Back Pain, if available

  24 months

• Oswestry Disability Index (ODI) Scores, if available

  24 months

Interventions

Lumbar Interbody Fusion Devices DEVICE

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

Also known as: Static Posterior Lumbar Interbody Fusion (PLIF) cages, Expandable PLIF cages, Static Transforaminal Lumbar Interbody Fusion (TLIF) cages, Expandable TLIF cages

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature individuals with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2 to S1, who were treated with TLIF or PLIF surgery using an EXP or STC IBFD according to the surgeon's and patient's choice, as part of the standard of care.

You may qualify if:

• \. 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:
• Was at least 18 years of age and skeletally mature at the time of surgery
• Had clinical and radiological evidence of DDD of the lumbar spine
• 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 may not qualify if:

• 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
• Surgery with the IBFD(s) at more than 2 contiguous levels
• Surgery with the IBFD(s) at levels outside the range of L2 to S1
• Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
• Any contraindications listed in the cleared product labeling
• Osteoporosis, Other Systemic Bone D.O. T score ≤ -1.5
• BMI \> 40
• Systemic Infection
• H/O IV Drug Use
• Cancer

Sponsors & Collaborators

• Spine and Scoliosis Research Associates: lead

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Carolina NeuroSurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Rothman Orthopaedic Institute

Bensalem, Pennsylvania, 19020, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Aaron Buckland, MD

  SSRA Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: August 16, 2022
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (4)