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

NCT04980729 | Completed

• 1 other identifier: 2020-453
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Tumor

Keywords

Pelvic tumor; Acetabular reconstruction; Navigation template; Hip rotation center; Placement in situ

Outcome Measures

Primary Outcomes (1)

• Compare the change of acetabular rotation center before and after surgery between the template-guided group and the traditional operation group.

  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.

  "through study completion, an average of 2 years"

Study Arms (3)

the template-guided group

EXPERIMENTAL

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

Device: Acetabular reconstruction after tumor resection.

the traditional operation group

ACTIVE COMPARATOR

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

Device: Acetabular reconstruction after tumor resection.

the validation group

SHAM COMPARATOR

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

Device: Acetabular reconstruction after tumor resection.

Interventions

Acetabular reconstruction after tumor resection. DEVICE

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.

the template-guided group; the traditional operation group; the validation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Nong Lin

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

• Donghua Huang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a "Retrospective Cohort Study" through retrospectively collecting patients undergoing acetabulum reconstruction after pelvic tumor resection. The patients were interfered with or without the acetabular navigation template during the hip reconstruction process.

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: July 28, 2021
• Study Start: January 1, 2013
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share