thoracolumbar scoliosis and/or kyphosis of 4 or more segments in adult patients
Conditions
Interventions
Group 1: 50 patients
With Utilization of the Mazor X Stealth Edition (Fa. Medtronic) robotic system
Group 1: With robotic usage: “Robotic“
Group 2: 50 Patienten
Without utilization of the Mazor X Ste
Sponsors
Zentrum für Wirbelsäulen- und Skoliosetherapie Malteser Waldkrankenhaus St. Marien
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Deformities of the spine of adult patients with indication of spondylodesis (instrumented fusion) over at least 4 segments. Written informed consent
Exclusion criteria
Exclusion criteria: • Refusal of study participation of the patient • Spondylodesis of less than 4 segments • Pregnancy • Inability to understand the required documents • Nursing case • Active infection • Active tumor disease • Acute fracture of the spine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypothesis: The usage of the robotic assist system Mazor X increases the precision of pedicle screw placement in adult deformity surgery in comparison to standard procedure. Primary objective data: Screw positioning data via computed tomography in the group 1 “robotic“ and group 2 “non-robotic“. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • The utilization of the robotic assist system Mazor X leads to significant lower complication rates in comparison to the standard procedure. • The utilization of the robotic assist system Mazor X leads to comparable, non-inferior results of correction in terms of classification, angles of the spine and pelvis (SVA, PT, PI, SS, LL) • The utilization of the robotic assist system Mazor X leads to comparable, non-inferior clinical outcome (clinical PROMS (SRSr 22, ODl, VAS spine, EQ5D, HADS-D) • The utilization of the robotic assist system Mazor X decreases blood loss and X ray dosage (dosis area product) • The utilization of the robotic assist system Mazor X decreases the number of revision surgeries Secondary objective data: Surgical complications, Classification, radiological parameters of the spine and pelvis (SVA, PT, PI, SS, LL), clinical PROMS (SRSr 22, ODl, VAS spine, EQ5D, HADS-D), blood loss, X ray dosage (dosis area product) in the group 1 “robotic“ and group 2 “non-robotic“. | — |
Countries
Germany
Contacts
Public ContactAlexander Hammer
Zentrum für Wirbelsäulen- und Skoliosetherapie Malteser Waldkrankenhaus St. Marien
Outcome results
None listed