An observational study in Degenerative Disc Disease (DDD), sponsored by Spine and Scoliosis Research Associates. Completed at 4 sites in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by Spine and Scoliosis Research Associates · Observational
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
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's enrollment of 465 is above the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Spine and Scoliosis Research Associates is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
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
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
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
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
Spine and Scoliosis Research Associates