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New bone graft aims to cut repeat surgeries in spine deformity patients

NCT ID NCT05038527

Disease control Sponsor: Rigshospitalet, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared a new bone graft material (ABM/P-15) to the standard bone graft in 120 adults having surgery for spinal deformity. The goal was to see if the new graft leads to fewer additional surgeries and better bone healing. Patients were randomly assigned to receive either the new or standard graft, and results were tracked over time.

What this could mean

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

Active substance
ABM/P-15 bone graft (anorganic bovine bone mineral coated with a bioactive peptide)
What this could lead to
If it works, this could mean fewer repeat surgeries and faster bone healing for adults undergoing spinal deformity surgery.
What could go wrong
This is a single, completed trial with 120 patients, so results may not apply to everyone. The new graft might not be better than the standard approach.

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

120 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 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.

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: * Indication for ASD surgery * Indication for the use of bone graft * Age ≥ 18 years old at the date of surgery Exclusion Criteria: * ASA ≥ 4 * Formally diagnosed with a disease affecting the bone metabolism or wound healing (severe osteoporosis, osteomalacia, Pagets disease, hyperparathyreoidism etc.) * Disseminated cancer diseases * Hypersensitivity to any of the i-FACTOR Peptide Enhanced Bone Graft ingredients * Smoking, extensive alcohol use or abuse of hallucinating drugs * Severe liver or kidney disorders * Pregnancy or breastfeeding patients * Patients estimated not to be able to understand the information sheet or patients, who do not consent to participate in the study. * Severe psychiatric diseases * Ongoing infections

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Conditions

The condition(s) this trial relates to.

vertebral column disorder

As listed by the trial registrant

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

Adverse events Bone graft; complications Spine deformity

Contacts and locations

Locations

  • Rigshospitalet, Department of Orthopedics, Spine Unit

    Copenhagen, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.