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

Zhejiang University

Status: Completed

Conditions: Pelvic Tumor

Treatments: Device: Acetabular reconstruction after tumor resection.

Study type: Interventional

Funder types: Other

Identifiers

NCT04980729

2020-453

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All the patients diagnosed with a pelvic tumor；
2. Underwent limb salvage surgery following type II or II+III pelvic resection；
3. Acetabulum reconstruction using a modular, titanium hemipelvic prosthesis.

Exclusion criteria

1. A lack of postoperative CT images;
2. Having undergone revision surgery or noninitial/primary resection;
3. unable to calculate the hip displacement by the specific measurement method we proposed.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

the template-guided group

Experimental group

Description:

In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction using a modular hemipelvic prosthesis.

Treatment:

Device: Acetabular reconstruction after tumor resection.

the traditional operation group

Active Comparator group

Description:

In the traditional operation group (n = 14), acetabulum was manually reconstructed using a modular hemipelvic prosthesis by the surgeon's experience.

Treatment:

Device: Acetabular reconstruction after tumor resection.

the validation group

Sham Comparator group

Description:

In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without acetabulum reconstruction.

Treatment:

Device: Acetabular reconstruction after tumor resection.