NCT05593146 A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction
| NCT ID | NCT05593146 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Periacetabular Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2023-04-13 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05593146 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Periacetabular Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05593146 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05593146 currently recruiting?
Yes, NCT05593146 is actively recruiting participants. Contact the research team at email@zju.edu.cn for enrollment information.
Where is the NCT05593146 trial being conducted?
This trial is being conducted at Ningbo, China.
Who is sponsoring the NCT05593146 clinical trial?
NCT05593146 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 118 participants.