3D-printed drilling guides for optimal screw placement in acetabular fracture surgery

Conditions: acetabular fracture
fracture of the hip joint
10017322
10005944

Registration Number: NL-OMON47996

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Patients >= 18 years with an acute (2 weeks from the injury) displaced
acetabular fracture
- Available diagnostic (preoperative) CT scan with slice thickness of <= 1mm.
-Only patients surgically treated with an anterior intrapelvic approach

Exclusion Criteria

- Patients < 18 years at the time of the incident.
- No availability of a diagnostic CT scan.
- *Late* acetabular fractures (> 2 weeks after the injury).
- Pathological fractures.
- Patient with previous hip surgery or surgery in the pre-peritoneal space
(Stoppa approach) making
an anterior intrapelvic approach hardly possible.
- Patient unfit for acetabular surgery.
- Patients with body-mass index (BMI) >35.
- Acetabular fractures not suitable for an anterior intrapelvic approach

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the accuracy of the screw placements. The accuracy of the screw<br /><br>placement (the difference between the intended position and the achieved<br /><br>position will be determined in terms of screw direction in degrees) which will<br /><br>be assessed, by matching the preoperative virtual planning with the<br /><br>post-operative CT images. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess whether the use of 3D guided screw placement reduces the residual<br /><br>fracture displacement compared to a similar retrospective cohort. Residual<br /><br>fracture displacement is measured on the post-operative CT-scan in terms of:<br /><br>Gap (mm displacement in line with articular surface) and step-off (mm<br /><br>displacement perpendicular to the articular surface).<br /><br>- To assess whether 3D guided surgery leads to an increase in the efficiency of<br /><br>the operative treatment in terms of: operation time, time for plate contouring<br /><br>and fixation and surgeons satisfaction (about implant handling, positioning and<br /><br>fixation).</p><br>