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3D-Printed spine implant aims to rebuild bones after tumor removal

NCT ID NCT05396222

Disease control Sponsor: National Taiwan University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tests a custom 3D-printed implant designed to rebuild the spine after removing a tumor. The implant is less rigid than traditional ones, which may help bone grow better and reduce sinking. Researchers will follow 18 adults for safety and how well the implant fuses with the spine.

What this could mean

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

Active substance
3D-printed custom-made non-rigid biomimetic implant
What this could lead to
If successful, this implant could offer a safer, more effective way to rebuild the spine after tumor surgery, with better bone healing and less implant sinking.
What could go wrong
This is a very early study with only 18 participants, so results may not apply to everyone. The implant could still fail, sink, or cause complications.

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 18 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2028

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.

Ages

20 to 79 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. Age 20 - 79 years; 2. Patient meet the indication for 1- to 3- level corpectomy, for primary bone tumor at spine, or metastatic tumor at spine. 3. Deficit confirmed by CT, MRI, and X-ray; 4. Pathology level located from C3 to L5. 5. Physically and mentally able and willing to comply with the protocol; 6. Signed informed consent; 7. NTU Spine Multidisciplinary Board confirmed tumor excision surgery is indicated. 8. Life expectancy longer than 6 months (Tokuhashi Scoring System) Exclusion Criteria: 1. Patient does not meet the indication of corpectomy, which is under the surveillance. 2. More than three vertebrae required corpectomy; 3. Corpectomy levels above C3 and below L5 4. T-score less than -2.5 5. Known allergy to device materials - such as titanium 6. Any diseases or conditions that would preclude accurate clinical evaluation; 7. Daily, high-dose oral and/or inhaled steroid or a history of chronic use of high dose steroids; 8. BMI \> 35 9. Life expectancy less than 6 months - (Tokuhashi Scoring System) 10. The subject has received radiation therapy or chemotherapy at the trial site within one year; 11. Anterior spine surgery has been received at or near the spine surgery site; 12. The subject has systemic infection,or focal vertebral infection or trauma; 13. The subject has endocrine disorders or metabolic disorders known to affect bone formation, such as: Paget's disease, renal osteodystrophy, hypothyroidism; 14. The subject has neuromuscular diseases, those at risk of instability, implant fixation failure or postoperative care complications, including: spina bifida, cerebral palsy, and multiple sclerosis; 15. Osteopenia, osteomyelitis; 16. Pregnant women.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm in the spinal cord spinal cord cancer spinal cord neoplasm

As listed by the trial registrant

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

Spinal tumor

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

  • National Taiwan University Hospital

    Taipei, Taiwan

More trials for these conditions

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