NCT04980729

A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.

Completed NA Last updated 28 July 2021

What this trial tests

NA trial testing Acetabular reconstruction after tumor resection. in Pelvic Tumor in 36 participants. Completed in 31 July 2020.

Timeline

1 January 2013

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	1 January 2013
Primary completion	31 July 2020
Estimated completion	31 July 2020

Drugs / interventions tested

• Acetabular reconstruction after tumor resection.

Conditions studied

• Pelvic Tumor — all drugs for Pelvic Tumor →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Eligibility, any sex, with Pelvic Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Acetabular reconstruction in situ after extensive pelvic resection is technically challenging because the significant loss of bone stock and bony landmarks. The aim of the present study was to investigate the feasibility of an individualized navigation template for acetabular reconstruction following pelvic malignancy resection.

Methods:

This retrospective cohort study included patients who underwent type II or II+III pelvic tumor resection and reconstruction using a modular hemipelvic prosthesis. In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.