Insufficiency Fractures, Mobility Limitation, Pelvic Fracture
Conditions
Keywords
Fracture Fixation, Fragility Fractures, Pelvis, Surgical Procedures, Minimal Invasive
Brief summary
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.
Interventions
DEVICEiFuse-3D implant
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.
Sponsors
University of Witten/Herdecke
SI-BONE, Inc.
Johannes Gutenberg University Mainz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge | Time 8 days (discharge) after surgery | The proportion is shown with frequencies and corresponding percentages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who achieve pre-fracture mobility within six weeks. | Time six weeks after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieve pre-fracture mobility at three months. | Time three months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieve pre-fracture mobility at six months. | Time six months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieve pre-fracture mobility at 12 months. | Time 12 months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge. | Time 8 days (discharge) after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieved an FMS ≥ 2 within six weeks. | Time six weeks after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieved an FMS ≥ 2 at three months. | Time three months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieved an FMS ≥ 2 at six months. | Time six months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Proportion of patients who achieved an FMS ≥ 2 at 12 months. | Time 12 months after surgery | The proportion is shown with frequencies and corresponding percentages. |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks. | Time six weeks after surgery | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months. | Time three months after surgery | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months. | Time six months after surgery | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months. | Time 12 months after surgery | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Timed up and go test after six weeks. | Time six weeks after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Timed up and go test after three months. | Time three months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Timed up and go test after six months. | Time six months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Timed up and go test after 12 months. | Time 12 months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Opioid consumption and osteoporosis medication in the last six weeks. | Time six weeks after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Opioid consumption and osteoporosis medication in the last three months. | Time three months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Opioid consumption and osteoporosis medication in the last six months. | Time six months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Opioid consumption and osteoporosis medication in the last 12 months. | Time 12 months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in quality of life measured by the EuroQol-5D-3L after six weeks. | Time six weeks after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in quality of life measured by the EuroQol-5D-3L after three months. | Time three months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in quality of life measured by the EuroQol-5D-3L after six months. | Time six months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Change in quality of life measured by the EuroQol-5D-3L after 12 months. | Time 12 months after surgery | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. |
| Proportion of screws or iFuse fractures. | Time within 12 months | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. |
| Proportion of screw sintering. | Time within 12 months | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. |
| Proportion of sintering/migration of the iFuse implant. | Time within 12 months | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. |
| Proportion of radiological signs of loosening. | Time within 12 months | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. |
| Proportion of infections. | Time within 12 months | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORErol Gercek, Prof.
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed