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3D Virtual Surgery In an Orthopaedic-trauma Network (3D ViSION trial) A randomised-controlled study initiated by the department of Trauma Surgery, Orthopaedic Surgery and the 3D lab of the University Medical Center Groningen

3D Virtual Surgery In an Orthopaedic-trauma Network (3D ViSION trial) A randomised-controlled study initiated by the department of Trauma Surgery, Orthopaedic Surgery and the 3D lab of the University Medical Center Groningen - 3D ViSION trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51389
Enrollment
492
Registered
2022-10-20
Start date
2023-01-17
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

ankle and wrist

Interventions

In the intervention group, surgery will be prepared by using a 3D virtual fracture model (based on the CT images) in addition to conventional imaging. In the control group the preoperative planning wi

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Acute fractures (= 18 years - Understanding of the Dutch language Table: Fracture types which are eligible for inclusion. Nr Fracture Location AO classification 1 Radius Distal 2R3B; 2R3C 2 Tibia Proximal 41B; 41 C 3 Tibia/Ankle Distal 43B; 43C / 44B/C with tertius fragment

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

MeasureTime frame
1. The primary endpoint is patient-reported outcome, which will be assessed with validated follow-up questionnaires.

Secondary

MeasureTime frame
2. The secondary endpoint is the residual fracture displacement (gap and step-off in mm), as measured on the postoperative CT-scan. 3. The tertiary endpoint is operation efficiency in terms of operation time (minutes), blood loss (mL) and radiation exposure (mGym2). 4. The last endpoint is the cost effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)