Degenerative Disc Disease (DDD)NCT05536453
Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
An observational study of Degenerative Disc Disease (DDD), run by Spine and Scoliosis Research Associates at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Degenerative Disc Disease (DDD)
- What is being tested?
- Lumbar Interbody Fusion Devices
- Type of treatment
- Medical device
- How many people
- 465 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Aug 2022to 16 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
- Was at least 18 years of age and skeletally mature at the time of surgery
- Had clinical and radiological evidence of DDD of the lumbar spine
- 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
Who cannot join
- 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
- Surgery with the IBFD(s) at more than 2 contiguous levels
- Surgery with the IBFD(s) at levels outside the range of L2 to S1
- Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
- Any contraindications listed in the cleared product labeling
- Osteoporosis, Other Systemic Bone D.O. T score ≤ -1.5
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- BMI > 40
- Systemic Infection
- H/O IV Drug Use
- Cancer
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rothman Orthopaedic Institute
Bensalem, Pennsylvania, 19020
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, 28204
New York University Langone Health
New York, New York, 10016
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence
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
- 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.
- 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.
- achieve radiographic fusion at a rate consistent with the state-of-the-art
- achieve significant improvements in pain and function compared to baseline
- experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery
- not demonstrate any intraoperative complications during the implant process
- operative approach does not correlate with increased rates of subsidence
- Conditions
- Degenerative Disc Disease (DDD)
- Being tested
- Lumbar Interbody Fusion Devices
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Interbody Fusion DevicesDevice
Also called Static Posterior Lumbar Interbody Fusion (PLIF) cages, Expandable PLIF cages, Static Transforaminal Lumbar Interbody Fusion (TLIF) cages, Expandable TLIF cages
Posterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (6)
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.
Measured: 24 months
Incidence of End Plate Violation
Incidence of end plate violation determined based upon operative reports and medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start16 Aug 2022
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease (DDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine and Scoliosis Research Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Buckland, MD, Principal investigator, SSRA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536453
- Sponsor's protocol ID
- CP-000003
- Status last verified
- Oct 2025
- First submitted
- 7 Sep 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparative Analysis of Interbody Fusion Devices in the Lumbar Spine for Occurrence of Subsidence
- ClinicalTrials.gov ID
- NCT05536453
- Acronym / sponsor ID
- CP-000003
- Conditions
- Degenerative Disc Disease (DDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Spine and Scoliosis Research AssociatesUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- achieve radiographic fusion at a rate consistent with the state-of-the-art
- achieve significant improvements in pain and function compared to baseline
- experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery
- not demonstrate any intraoperative complications during the implant process
- operative approach does not correlate with increased rates of subsidence
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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:
- Was at least 18 years of age and skeletally mature at the time of surgery
- Had clinical and radiological evidence of DDD of the lumbar spine
- 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
Key exclusion criteria (10 listed)
- 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
- Surgery with the IBFD(s) at more than 2 contiguous levels
- Surgery with the IBFD(s) at levels outside the range of L2 to S1
- Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
- Any contraindications listed in the cleared product labeling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Interbody Fusion DevicesAlso: Static Posterior Lumbar Interbody Fusion (PLIF) cages, Expandable PLIF cages, Static Transforaminal Lumbar Interbody Fusion (TLIF) cages, Expandable TLIF cagesPosterior Lumbar Interbody Fusion device placed to treat symptoms associated with degenerative disc disease | Device | – |
Primary outcome
Incidence of Subsidence
Time frame: 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.
6 secondary outcomes
Incidence of Fusion
Time frame: 24 months
Incidence of End Plate Violation
Time frame: 12 months
Visual Analog Scale (VAS) Scores for Leg Pain, if available
Time frame: 24 months
VAS Scores for Back Pain, if available
Time frame: 24 months
Oswestry Disability Index (ODI) Scores, if available
Time frame: 24 months
Incidence of Device and/or Procedure-Related Adverse Events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Buckland, MD principal investigator
SSRA Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease (DDD), run by Spine and Scoliosis Research Associates at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Subsidence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.