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

A Multi-center, Double-blinded, Randomized Controlled Study Comparing Modified Cup Anteversion vs Conventional Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction

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

Study Overview

• Status: Recruiting
• Conditions: Periacetabular Tumor
• Intervention / Treatment: Behavioral: modified anteversion angle placement(( α-15°)±10°); Behavioral: conventional anteversion angle placement ( α±10°)

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 Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hao Qu, MD; Phone Number: 13666615399; Email: email@zju.edu.cn
• Study Contact Backup: Name: Nong Lin, MD; Phone Number: 13958195545; Email: ldoctor@yeah.net

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 311200
      • Recruiting
      • Ningbo No.6 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified anteversion angle placement (( α-15°)±10°) of the acetabular component; 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	Behavioral: 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.
Placebo Comparator: conventional anteversion angle placement ( α±10°) of the acetabular component; 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The endpoint for patient participation will dislocate	postoperative hip dislocation	followed for 1 years postoperatively for study end points

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: dislocation, endoprosthetic reconstruction, anteversion angle, pelvis
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: 2022_QH1020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No