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Spine surgery devices under the microscope: do they really work?

NCT ID NCT07615491

Knowledge-focused Sponsor: Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 561 people who have already had spine surgery using METROSAN spinal implants and BONEGRAFT bone fillers. Researchers want to see how well these devices work and if any new safety issues pop up over a year. It's an observational study, meaning patients get standard care and no extra tests or treatments are added.

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 561 people

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

Started

Apr 2026

Expected to finish

Sep 2028

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.

Who is studied

Patients aged 18 years or older who underwent cervical or thoracolumbar spinal instrumentation and/or fusion surgery under current medical practice with appropriate indications, in whom at least one of the investigational devices was used, and who meet all inclusion and no exclusion criteria. The study will enroll a total of 561 subjects across 17 product groups (33 subjects per group, accounting for a 10% dropout rate) at 3 centers in Turkey. All patients who underwent reverse shoulder arthroplasty or hemiarthroplasty using Tıpmed™ Primary Hip Prosthesis Systems, who were informed about this study and voluntarily agreed to participate will be included.

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: * 18 years of age or older. * Skeletally mature. * Male or female. * Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice. * Titania® spinal stabilization/fusion systems and/or BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation. * No general health condition contraindicating surgery. * No legal restriction (military service, incarceration, or equivalent). * Provision of signed and dated Informed Consent Form (ICF) Exclusion Criteria: * Participation in another interventional clinical investigation * Suspected or confirmed pregnancy * Morbid obesity * Neurological or psychiatric conditions preventing compliance with postoperative care and instructions * Active spinal or systemic infection * High fever or leukocytosis * Severe osteoporosis and/or disease affecting bone metabolism * Known allergy or hypersensitivity to PEEK, Titanium, or PMMA * Congenital abnormality, tumor, or other condition preventing secure implant fixation or likely to shorten implant useful life * Inadequate tissue coverage at the operative site * Legally restricted individuals (military personnel, prisoners, etc.)

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spinal cord neoplasm spinal fracture spinal injury spinal stenosis spondylolisthesis

As listed by the trial registrant

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

Degenerative disc disease (DDD) Spinal deformities Spinal infections Spinal stenosis Spinal trauma Spinal tumors Spondylolisthesis Vertebral fractures

How to take part

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

  1. The places running it

    3 sites. 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

  • Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery

    NOT_YET_RECRUITING

    Izmir, 35390, Turkey (Türkiye)

  • Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery

    RECRUITING

    Izmir, 35150, Turkey (Türkiye)

  • Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery

    NOT_YET_RECRUITING

    Van, 65000, Turkey (Türkiye)

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