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

Primary Purpose

Pelvic Tumor

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acetabular reconstruction after tumor resection.
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Tumor focused on measuring Pelvic tumor, Acetabular reconstruction, Navigation template, Hip rotation center, Placement in situ

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    the template-guided group

    the traditional operation group

    the validation group

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2021
    Last Updated
    July 19, 2021
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04980729
    Brief Title
    A Positioning Navigation Template for Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection.
    Official Title
    A Novel Positioning Navigation Template for Accurately and Precisely Assisting the Placement of Modular Hemipelvic Endoprostheses for Patients Undergoing Pelvic Bone Tumor Resection: A Retrospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    July 31, 2020 (Actual)
    Study Completion Date
    July 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Tumor
    Keywords
    Pelvic tumor, Acetabular reconstruction, Navigation template, Hip rotation center, Placement in situ

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the template-guided group
    Arm Type
    Experimental
    Arm Description
    In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction using a modular hemipelvic prosthesis.
    Arm Title
    the traditional operation group
    Arm Type
    Active Comparator
    Arm Description
    In the traditional operation group (n = 14), acetabulum was manually reconstructed using a modular hemipelvic prosthesis by the surgeon's experience.
    Arm Title
    the validation group
    Arm Type
    Sham Comparator
    Arm Description
    In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without acetabulum reconstruction.
    Intervention Type
    Device
    Intervention Name(s)
    Acetabular reconstruction after tumor resection.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Compare the change of acetabular rotation center before and after surgery between the template-guided group and the traditional operation group.
    Description
    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.
    Time Frame
    "through study completion, an average of 2 years"

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nong Lin
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Donghua Huang
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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