Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID05367505

Titanium Fusion Implant with Trans-iliac Screws for Pelvic Insufficiency Fractures: A Prospective Pilot Study

Led by University of Witten/Herdecke · Updated on 2026-04-15

60

Participants Needed

3

Research Sites

N/A

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

Researchers are evaluating a new surgical approach for patients aged 60 and older with insufficiency fractures of the pelvis, which are fractures due to weakened bones. This study focuses on using a titanium fusion implant called iFuse-3D combined with transiliac-transsacral screws to stabilize the pelvic fractures and potentially improve patient outcomes. The iFuse-3D implant is designed to reduce movement in the sacroiliac joint, which may help promote healing and better mobility. Participants will receive surgery involving the placement of the iFuse-3D implant together with trans-iliac screws to stabilize the pelvic fracture. The implant has a special triangular titanium design with a coating to prevent joint movement and displacement. This surgical method aims to reduce micromotion at the fracture site, which could improve recovery. The study observes patients from the time of surgery through hospital discharge and up to 12 months after surgery. During the study, researchers will assess how many patients regain their mobility levels from before the fracture at hospital discharge, with follow-up visits at six weeks, three months, six months, and one year. Assessments include measuring mobility using the Functional Mobility Score, pain levels, quality of life, opioid use, and physical performance tests. Safety is monitored by checking for implant or screw complications, infections, and any radiological signs of implant issues. The total follow-up period extends to 12 months after the surgery.

CONDITIONS

Brief Title

Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Legal capacity and ability to provide informed consent
  • Age 60 years or older
  • Acute or subacute (less than 2 months) posterior pelvic pain after low-energy trauma or spontaneous onset
  • Diagnosis confirmed by CT and/or MRI
  • Fracture classified as OF3 or OF4 according to OF Pelvis classification
  • Ability to move freely without a wheelchair before the fracture (Functional Mobility Score of 2 or higher)
Not Eligible

You will not qualify if you...

  • Uncontrolled psychiatric illness affecting participation (e.g., dementia, schizophrenia, major depression, personality disorder)
  • Pelvic fracture within the past year with failed healing or previous internal fixation of the pelvic ring
  • Inability to walk before the fracture
  • Prior lumbar spinal instrumentation involving more than two vertebrae or S1
  • Additional fractures limiting mobility
  • Pelvic fractures related to benign or malignant tumors
  • Neurological conditions affecting participation
  • Severe clinical conditions that risk inability to follow up (e.g., COPD, severe heart failure, Parkinson's disease, autoimmune diseases)
  • Pelvic conditions or anatomy that prevent surgery
  • Allergy to titanium or titanium alloys
  • Known opioid abuse for chronic pain
  • Participation in other interventional trials
  • Lack of surgical capability
  • Employment or dependent relationship with sponsor or investigator
  • Placement in an institution by court or administrative order

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 8 days or until hospital discharge

Participants receive a titanium fusion implant in combination with trans-iliac screws to treat pelvic insufficiency fractures.

1 surgery visit and hospital stay until discharge

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants are monitored for recovery and mobility, with assessments of pain, function, and implant stability over time.

Visits at 6 weeks, 3 months, 6 months, and 12 months post-surgery

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

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Research Team

K

Katharina Graf

R

René Geißen, Dr.

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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Published Research Related To This Trial

Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative.

Tim Pohlemann, Dirk Stengel, Georgios Tosounidis...

https://pubmed.ncbi.nlm.nih.gov/21513936