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 Groninge

Conditions: ankle and wrist
intra-articular fractures of the knee
bone fractures involving the joint
10005942
10005944

Registration Number: NL-OMON51389

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 492

Inclusion Criteria

- Acute fractures (<3 weeks after the initial injury)
- Fracture of one of the following body regions (distal Radius, proximal Tibia,
distal Tibia/Ankle, see table below for specific fracture types that are
eligible for inclusion)
- Operative treatment
- Availability of a diagnostic (Pre-operative) CT-Scan available (Slice
thickness <= 1 mm)
- Age >= 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

- Age < 18 years
- Previous injury with persistent functional impairment of the fracture site
- Non-operative treatment
- Complicated (open) fractures requiring a free flap
- Pathological fractures
- No understanding of the Dutch language

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The primary endpoint is patient-reported outcome, which will be assessed<br /><br>with validated follow-up questionnaires. </p><br>

Secondary Outcome Measures

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