Dutch Research for the Evaluation of Acetabular fracture Management in 3D
- Conditions
- Acetabular fracture
- Registration Number
- NL-OMON28665
- Lead Sponsor
- MCG
- 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.
- Associated type acetabular fracture types (posterior column and wall, transverse and posterior wall, T-type, anterior column and posterior hemitransverse, both column fractures).
- Elementary acetabular fracture types (isolated posterior wall, isolated posterior column, anterior wall, anterior column and transverse 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 The primary endpoint is the residual fracture displacement (in mm), as measured on the postoperative CT-scan.
- Secondary Outcome Measures
Name Time Method The secondary endpoint includes patient reported outcome, which will be assessed with validated follow-up questionnaires at one-year follow-up. Additionally, surgery related factors e.g. the total time for intra-operative bending manoeuvres, plate positioning and fixation, the surgeon’s satisfaction about implant fitting will be assessed. For the patient-specific implants, the accuracy of the screw positions will be assessed by matching the preoperative virtual planning with the post-operative CT images.