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

NCT05593146 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Phase 2

Started

2023-04-13

Last updated

2024-03-06

Condition(s) studied

Periacetabular Tumor

Investigational drug(s) / intervention(s)

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

modified anteversion angle placement(( α-15°)±10°): Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis pre- designed anteversion angle is assembled for reconstruction after tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.

conventional anteversion angle placement ( α±10°): Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis with predesigned anteversion angle is assembled for reconstruction following tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.

Study summary

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

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The endpoint for patient participation will dislocate — followed for 1 years postoperatively for study end points
postoperative hip dislocation

Trial sites (1)

Facility	City	Region	Status
Ningbo No.6 Hospital	Ningbo	Zhejiang	Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion Recruiting

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease Recruiting

Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases Active, not recruiting

China Longitudinal Aging and Cognitive Impairment Study Recruiting

Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05593146 on ClinicalTrials.gov ↗ ← All trials in China