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New titanium implant aims to get pelvic fracture patients walking again

NCT ID NCT05367505

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special titanium implant, called iFuse-3D, along with screws to treat pelvic fractures in people aged 60 and older. The goal is to see if this surgery helps patients get back to their usual walking ability by the time they leave the hospital. Fifty participants will be followed for up to three months to check mobility and recovery.

What this could mean

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

Active substance
iFuse-3D titanium implant and trans-iliac screws
What this could lead to
If successful, this approach could offer a more reliable surgical option for older adults with pelvic fractures, helping them regain mobility faster.
What could go wrong
This is a small, early pilot study with only 50 participants and no comparison group. The implant is already used for other conditions, but its benefit for pelvic fractures is unproven. Surgery always carries risks 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.

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

50 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Feb 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

60 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: * Legal capacity, capacity to inform * Presence of a written declaration of consent by the patient * Age: ≥ 60 years * Acute or subacute (less than 2 months) posterior pelvic girdle pain associated with low energy trauma or occurring spontaneously * Diagnosis confirmed by CT and/or MRI * The fracture corresponds to types OF3 and OF4 of the OF Pelvis classification. * Prior to the fracture, there was free, non-wheelchair mobility (Functional Mobility Score of 2 or higher) Exclusion Criteria: * Diagnosed uncontrolled psychiatric illness (e.g. dementia, schizophrenia, major depression, personality disorder) that could affect study participation or reporting of findings * History of pelvic fracture within one year with evidence of failure of fracture to heal or internal fixation of the pelvic ring of any type * Patients unable to ambulate before the fracture * Patient has had lumbar instrumentation of more than two vertebrae and/or instrumentation of S1 in the past * Additional fractures that limit mobility * OF-P associated with benign or malignant tumours of the pelvis * Abnormal neurological condition that could affect study participation * An unusual clinical condition associated with a high risk of not being able to follow up (e.g. COPD, severe heart failure, Parkinson's disease, autoimmune diseases) * Any pelvic condition or anatomical feature that makes surgery impracticable * Known allergy to titanium or titanium alloys * Known opioid abuse for chronic pain syndromes * Participation in other interventional trials * Lack of surgical capability * Persons in a dependent/employee relationship with the sponsor or investigator * Placement in an institution due to court or administrative order.

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Conditions

The condition(s) this trial relates to.

Fractures, Stress hip fracture Mobility Limitation

As listed by the trial registrant

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

Contacts and locations

Locations

  • Diakonie Krankenhaus

    Bad Kreuznach, 55543, Germany

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283, Germany

  • University Medical Center of the Johannes Gutenberg University Mainz

    Mainz, 55131, Germany

More trials for these conditions

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