Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

NCT ID: NCT05536453

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 465 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2025-07-16

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

Conditions

Degenerative Disc Disease (DDD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Lumbar Interbody Fusion Devices

Posterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease

Intervention Type: DEVICE

Other Intervention Names

Static Posterior Lumbar Interbody Fusion (PLIF) cages; Expandable PLIF cages; Static Transforaminal Lumbar Interbody Fusion (TLIF) cages; Expandable TLIF cages

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spine and Scoliosis Research Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Buckland, MD

Role: PRINCIPAL_INVESTIGATOR

SSRA Inc.

Locations

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

Countries

United States

Other Identifiers

CP-000003

Identifier Type: -

Identifier Source: org_study_id