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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Interbody Fusion Devices | Device | Posterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Buckland, MD | SSRA Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| New York University Langone Health |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 24 months |
| Incidence of End Plate Violation | Incidence of end plate violation determined based upon operative reports and medical records. | 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. | 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. | 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. | 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. | 24 months |
| New York |
| New York |
| 10016 |
| United States |
| Carolina NeuroSurgery & Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Rothman Orthopaedic Institute | Bensalem | Pennsylvania | 19020 | United States |