Fixation of custom 3D metal printed pelvic implants. A Clinical RSA study
- Conditions
- Pelvic defects
- Registration Number
- NL-OMON22611
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
•Patients eligible to be treated with a 3DPI for:
oPelvic tumour resection
oFailed total hip arthroplasty with Paprosky type 2C, 3A and 3B defects
oSevere acetabular bone loss due to other reasons with Paprosky type 2C, 3A and 3B defects
•Patients aged 18 years and older
•Patient is able and willing to consent and participate in the study by signing and dating and IRB-approved consent form
•Patient is willing to attend the follow-up evaluations at the LUMC (these evaluations will take place during regular clinical follow-up moments), for a minimum of two years post-operatively.
Primary exclusion criteria:
•Patients who are unable or unwilling to cooperate in routine follow-up program
•Patients who are mentally or cognitively disturbed
•No written and signed Informed Consent
•Active local or systemic infection
•Insufficient Dutch language proficiency
Secondary exclusion criteria:
•Insufficient or poorly distributed RSA markers visible on baseline RSA radiographs which does not improve after repositioning the patient (2 attempts): the patient will be excluded from the RSA study, but patients will have regular clinical follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method