NCT05593146RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 21 Oct 2022
- Start date
- Apr 2023
- Primary completion date
- Dec 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT05593146
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From Apr 2023 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient used to conduct surgery on his/her hip joint
- Patients cannot self-assess postoperative function after surgery
Other illness
- The patient's current surgery aimed for hip revision for implant failure or infection
Other
- 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
- According to the judgment of the investigator/supervisor, there may be difficulties in completing postoperative follow-up
- Subjects have participated in similar research projects
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ningbo No.6 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.