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

Not Applicable

Completed

• Conditions: Pelvic Tumor
• Interventions: Device: Acetabular reconstruction after tumor resection.

• Registration Number: NCT04980729
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the template-guided group	Acetabular reconstruction after tumor resection.	In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction using a modular hemipelvic prosthesis.
the traditional operation group	Acetabular reconstruction after tumor resection.	In the traditional operation group (n = 14), acetabulum was manually reconstructed using a modular hemipelvic prosthesis by the surgeon's experience.
the validation group	Acetabular reconstruction after tumor resection.	In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without acetabulum reconstruction.

Primary Outcome Measures

Name	Time	Method
Compare the change of acetabular rotation center before and after surgery between the template-guided group and the traditional operation group.	"through study completion, an average of 2 years"	Compare the change of acetabular rotation center (the displacement displayed in centimeters) before and after surgery between the template-guided group and the traditional operation group based on preoperative and postoperative CT images.