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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

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Zhejiang University

Status and phase

Enrolling
Phase 2

Conditions

Periacetabular Tumor

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05593146
2022_QH1020

Details and patient eligibility

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

Full description

Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim 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.

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 size. A standard error within 10° is accepted.

Enrollment

118 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

118 participants in 2 patient groups, including a placebo group

modified anteversion angle placement (( α-15°)±10°) of the acetabular component
Experimental group
Description:
α refers to the anatomical 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
Treatment:
Behavioral: modified anteversion angle placement(( α-15°)±10°)
conventional anteversion angle placement ( α±10°) of the acetabular component
Placebo Comparator group
Description:
α refers to the anatomical 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
Treatment:
Behavioral: conventional anteversion angle placement ( α±10°)

Trial contacts and locations

1

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Central trial contact

Hao Qu, MD; Nong Lin, MD

Data sourced from clinicaltrials.gov

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