3D navigated kyphoplasty versus standard 2D fluoroscopy guided kyphoplasty - a prospective randomised trial to compare accuracy of the trajectory, complications, radiation dose and outcome

3D navigated kyphoplasty versus standard 2D fluoroscopy guided kyphoplasty - a prospective randomised trial to compare accuracy of the trajectory, complications, radiation dose and outcome - kyphona

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012976

Enrollment

Registered

2017-09-20

Start date

2017-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M80.88 C79.5 T08.1

Interventions

Group 1: Standard 2D fluoroscopy guided kyphoplasty Group 2: 3D navigated kyphoplasty

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients in our hospital where kyphoplasty is indicated in at least one level (due to osteoporotic and/or pathological vertebral fracture) in the thoracolumbar spine, will be included

Exclusion criteria

Exclusion criteria: minors, inability to provide informed consent, pregnancy, additional surgical stabilisation in relation to the same segment, planned open surgery

Design outcomes

Primary

Measure	Time frame
We want to evaluate if the accuracy of the vertebroplasty-needle position is significantly better using 3D navigation in comparison to standard 2D fluoroscopy. To evaluate accuracy the modified Gertzbein and Robbins classification is used (grade 1, 2 high accuracy and grade 3,4,5 low accuracy).	—

Secondary

Measure	Time frame
We hypothesise that the rate of complications in relation to needle positioning is significantly lower in the navigated kyphoplasty group. Additionally we will evaluate if there is a significant difference in total radiation dose and surgery time, as well es postoperative outcome measured by VAS (Visuell Pain Scale); ODI (Oswestry Disability Index) and quality of life (SF-12,Eq5) before and after (3,12 months) surgery.	—

Measure

Time frame

We hypothesise that the rate of complications in relation to needle positioning is significantly lower in the navigated kyphoplasty group. Additionally we will evaluate if there is a significant difference in total radiation dose and surgery time, as well es postoperative outcome measured by VAS (Visuell Pain Scale); ODI (Oswestry Disability Index) and quality of life (SF-12,Eq5) before and after (3,12 months) surgery.

—

Countries

Germany

Contacts

Public ContactAnna Rienmüller

Klinikum rechts der Isar der TU München

anna.rienmueller@tum.de004989414072151

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026