Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

University of Zurich (UZH)

Status: Unknown

Conditions: Cement Augmentation; Vertebral Fracture

Treatments: Diagnostic Test: PET MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03369288

2017-01207

Details and patient eligibility

About

3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Men and women aged 18 to 70 years
• Minimum 3-year follow-up
• Single-level vertebral kyphoplasty
• Index surgery at UniversitätsSpital Zürich
• MRI-scan during initial treatment
• Informed consent provided

Exclusion criteria

• Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
• Intraoperative intradiscal cement leakage
• Previous history of spinal surgery except on the cervical spine
• Metastatic disease with skeletal involvement
• Known chronic diseases of the bone metabolism other than osteoporosis
• Documented pregnancy (see also 6.3)
• Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)