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Can a new bone graft match the gold standard for spinal fusion?

NCT ID NCT05238740

Disease control Sponsor: Lindenhofgruppe AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial compares two bone graft materials used during spinal fusion surgery: ViviGen, a cellular bone matrix, and rhBMP-2, a protein that stimulates bone growth. The goal is to see if ViviGen helps bones fuse together as effectively as rhBMP-2. Adults aged 18-70 with certain spinal conditions, like degenerative disc disease or spondylolisthesis, who need surgery on specific lower back segments may participate. The study measures fusion success via CT scans at 6 or 12 months, and also tracks pain and function over a year.

What this could mean

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

Active substance
ViviGen cellular bone matrix or recombinant human bone morphogenetic protein-2 (rhBMP-2), used as bone graft substitutes during spinal fusion surgery.
What this could lead to
If ViviGen works as well as rhBMP-2, it could offer a safer or equally effective option for helping bones fuse after spinal surgery.
What could go wrong
This is a single-center trial, and results may not apply broadly. Bone fusion rates can vary, and both treatments carry risks like inflammation or incomplete healing.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 168 people

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

Started

Oct 2022

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 70 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: Patients who have an indication for a monosegmental ALIF procedure on the L5/S1 segment or a monosegmental XLIF procedure on L4/5 (both ALIF and XLIF procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain * Patients must be 18 - 70 years of age * Patients must have understood and signed the study information and the informed consent form * Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the Informed Consent Exclusion criteria: * Patients under 18 years and over 70 years of age * Patients with tumour / spine trauma / known bone disease / Parkinson's disease and similar CNS disorders / diseases or injuries of the peripheral nerves * Other procedures or segment than mentioned in the inclusion citeriaAdditional planed spine surgeries after index surgery * Current smoking * Pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery) * Insufficient language skills in German * Inability to give informed consent * Refusal to participate in the study, unsigned study consent * Participation in another interventional study within the 30 days preceding and during the present study

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spondylolisthesis spondylosis

As listed by the trial registrant

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

Degenerative disc disease Spondylolisthesis Spondylosis

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

  • Orthopädie Sonnenhof

    RECRUITING

    Bern, 3006, Switzerland

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