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A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction

RecruitingPhase 2Ages 16 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT05593146 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup. The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement. PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age above 16 years old, gender is not limited. * Tumor involving periacetabulum, femoral head, femoral neck or proximal femur * Patients require 3D-printed hemipelvic endoprosthetic reconstruction following periacetabular tumor resection * The subject has an estimated survival period of at least one year or more. * The subjects with informed consent Exclusion Criteria: * The patient used to conduct surgery on his/her hip joint * The patient's current surgery aimed for hip revision for implant failure or infection * The patient didn't conduct hip endoprosthetic reconstruction * Patients with congenital defects in the gluteal muscle group, neurological function or pelvic tilt deformity severe enough to affect functional activity * Patients cannot self-assess postoperative function after surgery * According to the judgment of the investigator/supervisor, there may be difficulties in completing postoperative follow-up * Subjects have participated in similar research projects
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What it tests

  • modified anteversion angle placement(( α-15°)±10°)
  • conventional anteversion angle placement ( α±10°)
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Where

1 site
Ningbo No.6 Hospital
Ningbo, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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