Three-dimensional virtual surgical planning and patient-specific osteosynthesis with drilling guides for acetabular fracture surgery
- Conditions
- Hip joint/hip10005944
- Registration Number
- NL-OMON54324
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
- Patients >= 18 years with an acute (2 weeks from the injury) displaced
acetabular fracture will be included after a signed informed consent.
- Elementary acetabular fracture types (isolated posterior wall, isolated
posterior column, anterior wall, anterior column and transverse fractures)
- Associated type acetabular fracture types (posterior column and wall,
transverse and posterior wall, T-type, anterior column and posterior
hemitransverse, both column fractures).
- *Late* acetabular fractures more than 2 weeks after the injury
- Pathological fractures
- Patient with previous hip surgery or surgery in the pre-peritoneal space
(Stoppa approach) making an anterior or posterior pelvic approach hardly
possible.
- Patient unfit for acetabular surgery (e.g. anterior and posterior approach in
one tempi).
- Patients with body-mass index (BMI) >35.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the residual fracture displacement (in mm), as measured<br /><br>on the postoperative CT-scan. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint includes patient reported outcome, which will be<br /><br>assessed with validated follow-up questionnaires at one-year follow-up.<br /><br>Additionally, surgery related factors e.g. operation time, intraoperative blood<br /><br>loss, and complications. For the patient-specific implants, the accuracy of the<br /><br>screw positions will be assessed by matching the preoperative virtual planning<br /><br>with the post-operative CT images.</p><br>