New titanium implant aims to get pelvic fracture patients walking again
NCT ID NCT05367505
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
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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
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50 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Diakonie Krankenhaus
Bad Kreuznach, 55543, Germany
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Helios Universitätsklinikum Wuppertal
Wuppertal, 42283, Germany
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University Medical Center of the Johannes Gutenberg University Mainz
Mainz, 55131, Germany
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