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New spine implants aim to improve fusion in back surgery

NCT ID NCT06704919

Disease control Sponsor: Nitin Agarwal Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing two medical devices—conduit cages and Fibergraft—used together in spine surgery for people with degenerative disc disease or herniated discs. The cages help restore space between vertebrae, while Fibergraft is designed to support natural bone healing. Researchers will follow 100 patients for two years to see how well the spine fuses and track any complications.

What this could mean

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

Active substance
conduit cages and Fibergraft BG Putty (medical devices)
What this could lead to
If successful, this could show that combining these devices improves spine fusion rates and reduces complications after surgery.
What could go wrong
This is a small, early study without a comparison group, so results may not apply to everyone. Risks include typical surgery complications like infection or implant failure.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

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

Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

Ages

18 years and older

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. Age ≥ 18 years 2. Have a radiograph-based diagnosis of degenerative disc disease, ruptured or herniated discs, 3. Pathology of the cervical or lumbar spine. 4. Pathology to be between C2-T1 in the cervical group. 5. Pathology to be between L2-S1 in the lumbar group. 6. Patients with 1-2 contiguous levels in both ACDF and Lumbar groups. 7. Patients receiving the surgery/devices as standard of care prescribed by the treating physician. Exclusion Criteria: 1. Patients \< 18 years 2. BMI \> 40 kg/m2 to be excluded 3. Patients with a bone density (DEXA) score of \<2.0 to be excluded 4. 3 or more levels for ACDF or Lumbar interbody to be excluded 5. Patients with previous pseudoarthrosis or failed spondylodesis to be excluded 6. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded

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Conditions

The condition(s) this trial relates to.

Intervertebral Disc Displacement 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 Herniated disc

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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