Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

• Conditions: Degenerative Disc Disease (DDD)

• Registration Number: NCT05536453
• Lead Sponsor: Spine and Scoliosis Research Associates

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-16
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-08-16
• Study Completion: 2026-08-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Incidence of End Plate Violation	12 months	Incidence of end plate violation determined based upon operative reports and medical records.
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.
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.
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.

Trial Locations

Locations (4)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

New York University Langone Health; 🇺🇸 New York, New York, United States

Rothman Orthopaedic Institute; 🇺🇸 Bensalem, Pennsylvania, United States

Carolina NeuroSurgery & Spine Associates; 🇺🇸 Charlotte, North Carolina, United States