Actively Recruiting

Phase 2
Age: 16Years +
All Genders
NCT05593146

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-03-06

118

Participants Needed

1

Research Sites

268 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Previous surgery on the hip joint
  • Surgery aimed for hip revision due to implant failure or infection
  • Did not undergo hip endoprosthetic reconstruction
  • Congenital defects in the gluteal muscles, neurological function, or severe pelvic tilt deformity affecting function
  • Unable to self-assess postoperative function
  • Investigator judged difficulties in completing postoperative follow-up
  • Participation in similar research projects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ningbo No.6 Hospital

Ningbo, Zhejiang, China, 311200

Actively Recruiting

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Research Team

H

Hao Qu, MD

CONTACT

N

Nong Lin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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