Evaluating a new angle for hip cup placement to prevent dislocation after tumor surgery
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
PHASE2 · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT05593146
This study tests if changing the angle of the hip cup during surgery can help prevent dislocations in patients who have had tumor surgery on their hip.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT05593146 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates whether using a modified anteversion angle for the acetabular cup during hip reconstruction surgery can reduce the risk of dislocation compared to conventional placement. Patients undergoing acetabular tumor resection will be randomly assigned to receive either the modified angle or the standard angle. The study aims to assess dislocation rates within one year post-surgery, focusing on the relationship between the angle of the cup and dislocation occurrences. The hypothesis is that the modified angle will lead to fewer dislocations due to better alignment and reduced collision risk between components.
Who should consider this trial
Good fit: Ideal candidates are patients over 16 years old with periacetabular tumors requiring 3D-printed hemipelvic endoprosthetic reconstruction.
Not a fit: Patients who have previously undergone hip joint surgery or those requiring hip revision for implant failure or infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of dislocation in patients undergoing hip reconstruction after tumor removal.
How similar studies have performed: While similar studies have explored the impact of anteversion angles on dislocation rates, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ningbo, Zhejiang
- Ningbo No.6 Hospital — Ningbo, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Hao Qu, MD
- Email: email@zju.edu.cn
- Phone: 13666615399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periacetabular Tumor, dislocation, endoprosthetic reconstruction, anteversion angle, pelvis