Fixation of custom 3D metal printed pelvic implants. A Clinical RSA study

none0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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.

发起方

none