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

Phase 2

Recruiting

• Conditions: Periacetabular Tumor
• Interventions: Behavioral: conventional anteversion angle placement ( α±10°); Behavioral: modified anteversion angle placement(( α-15°)±10°)

• Registration Number: NCT05593146
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Study Start: 2023-04-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2027-12-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional anteversion angle placement ( α±10°) of the acetabular component	conventional anteversion angle placement ( α±10°)	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
modified anteversion angle placement (( α-15°)±10°) of the acetabular component	modified anteversion angle placement(( α-15°)±10°)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Henderson's failure mode	followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints	1: soft tissue failure; 2: aseptic loosening; 3: structural failure; 4: periprosthetic infection; 5: tumor progression
MSTS score	followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints	The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
TESS score	followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints	Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours

Trial Locations

Locations (1)

Ningbo No.6 Hospital; 🇨🇳 Ningbo, Zhejiang, China