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Trial Title:
A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction
NCT ID:
NCT05593146
Condition:
Periacetabular Tumor
Conditions: Official terms:
Joint Dislocations
Conditions: Keywords:
dislocation, endoprosthetic reconstruction, anteversion angle, pelvis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
modified anteversion angle placement(( α-15°)±10°)
Description:
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.
Arm group label:
modified anteversion angle placement (( α-15°)±10°) of the acetabular component
Intervention type:
Behavioral
Intervention name:
conventional anteversion angle placement ( α±10°)
Description:
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.
Arm group label:
conventional anteversion angle placement ( α±10°) of the acetabular component
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
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ningbo No.6 Hospital
Address:
City:
Ningbo
Zip:
311200
Country:
China
Status:
Recruiting
Start date:
April 13, 2023
Completion date:
June 1, 2028
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05593146
