Actively Recruiting
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Led by University of Witten/Herdecke · Updated on 2026-04-15
60
Participants Needed
3
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
University of Witten/Herdecke
Lead Sponsor
S
SI-BONE, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps. The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients. The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.
CONDITIONS
Official Title
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Legal capacity and ability to provide informed consent
- Written consent from the patient
- Age 60 years or older
- Acute or subacute (less than 2 months) posterior pelvic girdle pain from low-energy trauma or spontaneous onset
- Diagnosis confirmed by CT and/or MRI
- Fracture classified as OF3 or OF4 according to the OF Pelvis classification
- Free mobility without wheelchair prior to fracture (Functional Mobility Score of 2 or higher)
You will not qualify if you...
- Uncontrolled psychiatric illness affecting study participation or reporting (e.g., dementia, schizophrenia, major depression, personality disorder)
- Pelvic fracture within the past year with failed healing or previous pelvic ring fixation
- Unable to walk before the fracture
- Previous lumbar instrumentation of more than two vertebrae or S1
- Additional fractures limiting mobility
- Pelvic fractures associated with benign or malignant tumors
- Abnormal neurological conditions affecting participation
- High-risk clinical conditions limiting follow-up (e.g., COPD, severe heart failure, Parkinson's disease, autoimmune diseases)
- Pelvic anatomy or conditions making surgery impossible
- Known allergy to titanium or titanium alloys
- Known opioid abuse for chronic pain
- Participation in other interventional trials
- Lack of surgical capability
- Dependent or employee relationship with sponsor/investigator
- Institutionalization by court or administrative order
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Diakonie Krankenhaus
Bad Kreuznach, Germany, 55543
Actively Recruiting
2
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Germany, 55131
Actively Recruiting
3
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283
Actively Recruiting
Research Team
K
Katharina Graf
CONTACT
R
René Geißen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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