RecruitingNot ApplicableNCT05367505

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

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

Sponsor

University of Witten/Herdecke

Enrollment

60 participants

Start Date

Jan 9, 2023

Study Type

INTERVENTIONAL

Conditions

Mobility Limitation Pelvic Fracture Insufficiency Fractures

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

Min Age: 60 Years

Inclusion Criteria7

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 Criteria15

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.

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.