Using titanium implants and screws to treat pelvic fractures
Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
This study tests if using a special titanium implant and screws can help people with pelvic fractures regain their mobility and reduce pain faster after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Witten/Herdecke Academic / other |
| Locations | 3 sites (Bad Kreuznach and 2 other locations) |
| Trial ID | NCT05367505 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the iFuse-3D implant combined with transiliac screws for patients suffering from insufficiency fractures of the pelvis. The approach aims to minimize motion in the sacroiliac joint, promoting early fixation and long-term fusion to enhance recovery. The primary goal is to determine the percentage of patients who regain their pre-fracture mobility by the time they are discharged from the hospital. Participants will be closely monitored for improvements in mobility and pain relief following the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 and older who have experienced acute or subacute pelvic girdle pain due to low-energy trauma and were mobile prior to the fracture.
Not a fit: Patients with uncontrolled psychiatric illnesses or those who were unable to ambulate before the fracture may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mobility and quality of life for patients with pelvic insufficiency fractures.
How similar studies have performed: Previous studies have shown the iFuse-3D implant to be safe and effective for chronic sacroiliac pain, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bad Kreuznach and 2 other locations
- Diakonie Krankenhaus — Bad Kreuznach, Germany (Recruiting)
- University Medical Center of the Johannes Gutenberg University Mainz — Mainz, Germany (Recruiting)
- Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (Recruiting)
Study contacts
- Principal investigator: Erol Gercek, Prof. — University Medical Center of the Johannes Gutenberg University Mainz
- Study coordinator: Katharina Graf
- Email: katharina.graf@uni-wh.de
- Phone: +49 202 896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.