Clinical trial NCT05367505: Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Official title: Prospective Pilot Study With a Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Fracture
Insufficiency Fractures
Mobility Limitation
Keywords: Fracture Fixation
Fragility Fractures
Pelvis
Surgical Procedures
Minimal Invasive
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: SI-BONE, Inc.
name: Johannes Gutenberg University Mainz
First posted: 2022-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge
timeFrame: Time 8 days (discharge) after surgery
Secondary outcomes:
measure: Proportion of patients who achieve pre-fracture mobility within six weeks.
timeFrame: Time six weeks after surgery
measure: Proportion of patients who achieve pre-fracture mobility at three months.
timeFrame: Time three months after surgery
measure: Proportion of patients who achieve pre-fracture mobility at six months.
timeFrame: Time six months after surgery
measure: Proportion of patients who achieve pre-fracture mobility at 12 months.
timeFrame: Time 12 months after surgery
measure: Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge.
timeFrame: Time 8 days (discharge) after surgery
measure: Proportion of patients who achieved an FMS ≥ 2 within six weeks.
timeFrame: Time six weeks after surgery
measure: Proportion of patients who achieved an FMS ≥ 2 at three months.
timeFrame: Time three months after surgery
measure: Proportion of patients who achieved an FMS ≥ 2 at six months.
timeFrame: Time six months after surgery
measure: Proportion of patients who achieved an FMS ≥ 2 at 12 months.
timeFrame: Time 12 months after surgery
measure: Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks.
timeFrame: Time six weeks after surgery
measure: Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months.
timeFrame: Time three months after surgery
measure: Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months.
timeFrame: Time six months after surgery
measure: Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months.
timeFrame: Time 12 months after surgery
measure: Timed up and go test after six weeks.
timeFrame: Time six weeks after surgery
measure: Timed up and go test after three months.
timeFrame: Time three months after surgery
measure: Timed up and go test after six months.
timeFrame: Time six months after surgery
measure: Timed up and go test after 12 months.
timeFrame: Time 12 months after surgery
measure: Opioid consumption and osteoporosis medication in the last six weeks.
timeFrame: Time six weeks after surgery
measure: Opioid consumption and osteoporosis medication in the last three months.
timeFrame: Time three months after surgery
measure: Opioid consumption and osteoporosis medication in the last six months.
timeFrame: Time six months after surgery
measure: Opioid consumption and osteoporosis medication in the last 12 months.
timeFrame: Time 12 months after surgery
measure: Change in quality of life measured by the EuroQol-5D-3L after six weeks.
timeFrame: Time six weeks after surgery
measure: Change in quality of life measured by the EuroQol-5D-3L after three months.
timeFrame: Time three months after surgery
measure: Change in quality of life measured by the EuroQol-5D-3L after six months.
timeFrame: Time six months after surgery
measure: Change in quality of life measured by the EuroQol-5D-3L after 12 months.
timeFrame: Time 12 months after surgery
measure: Proportion of screws or iFuse fractures.
timeFrame: Time within 12 months
measure: Proportion of screw sintering.
timeFrame: Time within 12 months
measure: Proportion of sintering/migration of the iFuse implant.
timeFrame: Time within 12 months
measure: Proportion of radiological signs of loosening.
timeFrame: Time within 12 months
measure: Proportion of infections.
timeFrame: Time within 12 months
Other outcomes:
Locations:
city: Bad Kreuznach
country: Germany
facility: Diakonie Krankenhaus
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University Mainz
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
Study officials:
affiliation: University Medical Center of the Johannes Gutenberg University Mainz
name: Erol Gercek, Prof.
role: PRINCIPAL_INVESTIGATOR
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