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3D guided surgery for intra-articular fractures of the tibia

3D guided surgery for intra-articular fractures of the tibia - 3D TIBGUIDE study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49274
Enrollment
50
Registered
2020-03-11
Start date
2020-09-23
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Tibial plateau Fracture

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 years - Intra-articular fracture of the tibial plateau (AO type 41 B1-3 and C1-3) or the pilon tibiale (AO type 41 B1-3 and C1-3). - Indication for surgical treatment of these fractures (as decided by the treating surgeon according to the standard of care) - Written informed consent.

Exclusion criteria

Exclusion criteria: - Patients

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the accuracy of the screw placement (the difference between the intended position and the achieved position will be determined in terms of screw direction in degrees), which will be assessed by matching the preoperative virtual planning with the post-operative CT images.

Secondary

MeasureTime frame
The secondary endpoint is the residual fracture displacement (in mm), as measured on the postoperative CT-scan. Additionally, the surgical efficiency in terms of total time for intra-operative bending manoeuvres, plate positioning and fixation and the surgeon*s satisfaction about implant handling and positioning will be assessed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)