Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

Spine and Scoliosis Research Associates465 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

465

Conditions

Degenerative Disc Disease (DDD)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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: 1. Was at least 18 years of age and skeletally mature at the time of surgery 2. Had clinical and radiological evidence of DDD of the lumbar spine 3. 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

Locations (4)

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

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Incidence of Fusion

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.

Time frame: 24 months

Incidence of End Plate Violation

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

Time frame: 12 months

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

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.

Time frame: 24 months

VAS Scores for Back Pain, if available

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.

Time frame: 24 months

Oswestry Disability Index (ODI) Scores, if available

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.

Time frame: 24 months

Incidence of Device and/or Procedure-Related Adverse Events

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

Time frame: 24 months