Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
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