Actively Recruiting

Phase 2
Age: 16Years +
All Genders
ID05593146

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

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

118

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with periacetabular tumors who undergo reconstruction surgery after tumor removal. The study aims to find out if using a modified angle for placing the acetabular cup during surgery reduces the risk of hip dislocation within one year compared to the conventional angle. This research is a multi-center, double-blinded, randomized controlled trial led by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Participants are randomly assigned to receive either the modified anteversion angle placement or the conventional anteversion angle placement of the acetabular component during surgery. Both approaches use a 3D-printed osteotomy guide and prosthesis with pre-designed angles. Intraoperative X-ray fluoroscopy checks the cup angle to ensure it matches the predetermined criteria, adjusting it if necessary. During the one-year follow-up after surgery, researchers will monitor hip dislocation occurrences as the primary outcome. They will also assess function and recovery using MSTS and TESS scores and evaluate failure modes at 1 month, 3 months, 6 months, 9 months, and 1 year. The study includes detailed surgical evaluation and postoperative follow-up to measure safety and outcomes over this period.

CONDITIONS

Brief 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, any gender
  • Tumor involving periacetabulum, femoral head, femoral neck, or proximal femur
  • Need for 3D-printed hemipelvic endoprosthetic reconstruction following tumor resection
  • Estimated survival period of at least one year or more
  • Provide informed consent to participate
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 gluteal muscles, neurological function, or severe pelvic tilt deformity affecting activity
  • Unable to self-assess postoperative function
  • Expected difficulties completing postoperative follow-up
  • Participation in similar research projects before

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo acetabular tumor resection and reconstruction with either modified or conventional cup anteversion placement. Intraoperative X-ray fluoroscopy is used to evaluate and adjust the acetabular component angle as needed.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 1 year

Participants are followed for one year after surgery to monitor for dislocation and assess functional outcomes using MSTS, TESS, and Henderson's failure mode scores.

Visits at 1 month, 3 months, 6 months, 9 months, and 1 year postoperatively

Trial Site Locations

Total: 1 location

1

Ningbo No.6 Hospital

Ningbo, Zhejiang, China, 311200

Actively Recruiting

Loading map...

Research Team

H

Hao Qu, MD

N

Nong Lin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here