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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Conditions
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Pelvic Fracture, Insufficiency Fractures, Mobility Limitation

Intervention / Treatment
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* Device: iFuse-3D implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iFuse-3D<br>Titanium fusion implant in combination with trans-iliac screws | Device: iFuse-3D implant<br>* The iFuse Implant System consists of cannulated triangular titanium implants (Ti 6AI4V ELI, ASTM F136) with a porous coating of commercially pure titanium plasma spray (C.P. Ti, ASTM F1580) and a setting instrument. The coating and special shape of the implants prevent rotation or displacement of the sacroiliac (SI) joint. The placement instrument uses guide pins to achieve precise placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge | The proportion is shown with frequencies and corresponding percentages. | Time 8 days (discharge) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve pre-fracture mobility within six weeks. | The proportion is shown with frequencies and corresponding percentages. | Time six weeks after surgery | 
| Proportion of patients who achieve pre-fracture mobility at three months. | The proportion is shown with frequencies and corresponding percentages. | Time three months after surgery | 
| Proportion of patients who achieve pre-fracture mobility at six months. | The proportion is shown with frequencies and corresponding percentages. | Time six months after surgery | 
| Proportion of patients who achieve pre-fracture mobility at 12 months. | The proportion is shown with frequencies and corresponding percentages. | Time 12 months after surgery | 
| Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge. | The proportion is shown with frequencies and corresponding percentages. | Time 8 days (discharge) after surgery | 
| Proportion of patients who achieved an FMS ≥ 2 within six weeks. | The proportion is shown with frequencies and corresponding percentages. | Time six weeks after surgery | 
| Proportion of patients who achieved an FMS ≥ 2 at three months. | The proportion is shown with frequencies and corresponding percentages. | Time three months after surgery | 
| Proportion of patients who achieved an FMS ≥ 2 at six months. | The proportion is shown with frequencies and corresponding percentages. | Time six months after surgery | 
| Proportion of patients who achieved an FMS ≥ 2 at 12 months. | The proportion is shown with frequencies and corresponding percentages. | Time 12 months after surgery | 
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery | 
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery | 
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery | 
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery | 
| Timed up and go test after six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery | 
| Timed up and go test after three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery | 
| Timed up and go test after six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery | 
| Timed up and go test after 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery | 
| Opioid consumption and osteoporosis medication in the last six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery | 
| Opioid consumption and osteoporosis medication in the last three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery | 
| Opioid consumption and osteoporosis medication in the last six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery | 
| Opioid consumption and osteoporosis medication in the last 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery | 
| Change in quality of life measured by the EuroQol-5D-3L after six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery | 
| Change in quality of life measured by the EuroQol-5D-3L after three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery | 
| Change in quality of life measured by the EuroQol-5D-3L after six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery | 
| Change in quality of life measured by the EuroQol-5D-3L after 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery | 
| Proportion of screws or iFuse fractures. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months | 
| Proportion of screw sintering. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months | 
| Proportion of sintering/migration of the iFuse implant. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months | 
| Proportion of radiological signs of loosening. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months | 
| Proportion of infections. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive