Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

Degenerative Disc Disease (DDD) Clinical Trial

Official title:

A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05536453
• Other study ID #: CP-000003
• Status: Enrolling by invitation
• Start date: August 16, 2022
• Est. completion date: August 16, 2025

Study information

• Verified date: November 2023
• Source: Spine and Scoliosis Research Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: August 16, 2025
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease (DDD)
• Intervertebral Disc Degeneration

Intervention

Device:
• Lumbar Interbody Fusion Devices
Posterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Bensalem	Pennsylvania
United States	Carolina NeuroSurgery & Spine Associates	Charlotte	North Carolina
United States	New York University Langone Health	New York	New York
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Spine and Scoliosis Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 months
Secondary	Incidence of End Plate Violation	Incidence of end plate violation determined based upon operative reports and medical records.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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