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Which spine cage stays put? study compares expandable vs static implants

NCT ID NCT05536453

Knowledge-focused Sponsor: Spine and Scoliosis Research Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked back at 465 patients who had lumbar spine fusion surgery for degenerative disc disease. Researchers compared two types of implants (expandable cages and static cages) to see which ones were less likely to sink into the bone after surgery. The goal is to help surgeons choose the best device to reduce complications and improve patient outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lumbar interbody fusion devices (expandable and static cages)
What this could lead to
If successful, this study could help surgeons choose better-designed spine implants that are less likely to sink into the bone after fusion surgery.
What could go wrong
This is a retrospective review of past surgeries, not a controlled trial, so results may be influenced by patient selection or surgeon technique. The findings may not apply to all patients or newer devices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

465 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 110 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease (DDD)

Contacts and locations

Locations

  • Carolina NeuroSurgery & Spine Associates

    Charlotte, North Carolina, 28204, United States

  • New York University Langone Health

    New York, New York, 10016, United States

  • Rothman Orthopaedic Institute

    Bensalem, Pennsylvania, 19020, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

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