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

Launched by UNIVERSITY OF WITTEN/HERDECKE · May 9, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical treatment for patients with insufficiency fractures of the pelvis, which can cause pain and limit movement. The study is testing a special implant called iFuse-3D, used alongside other screws, to help stabilize the pelvic area and improve mobility. Researchers aim to find out how many patients can return to their usual activities by the time they leave the hospital after surgery.

To participate, individuals should be at least 60 years old and have recently experienced pelvic pain due to a low-energy injury, such as a fall. They should have been able to walk independently before the injury. The trial is currently looking for participants, and those who join will receive the new treatment and be monitored for their recovery. It's important to note that certain health conditions or previous injuries may prevent someone from being eligible to participate.

Gender

ALL

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.