search
Back to results

Navigation Surgery for Bone and Soft Tissue Tumor

Primary Purpose

Bone Tumors

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Navigation surgery
Navigation system
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Tumors focused on measuring computer-assisted surgery, bone tumor, We will evaluate whether computer-assisted surgery, will be feasible and safe for bone tumor resection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. First condition is that the benign tumor is located deeply in bones of extremities, or pelvis, so we anticipate the difficulty to find the tumor and to assess the adequacy of resection without the aid of computer-assisted navigation during operation.
  2. Second condition is when the violation of joint or growth plate is expected during removal of tumor due to its close proximity to joint or growth plate.

In case of malignant bone tumor, the sufficient preservation of joint anatomy should be required even with resection margin of 1.5 cm away from reactive zone of tumor. The sufficient preservation of joint is defined when at least 1 cm subchondral bone is remained after tumor resection, because 1 cm subchondral bone is required for fixation with allograft in subsequent reconstruction. The sufficient preservation of joint is also defined when articular surface is removed, but more than 50% of articular surface has to be saved.

Exclusion criteria were

  1. Patients who denied to perform navigation surgery after explanation of navigation surgery protocol
  2. Medically high-risk patients who could not withstand long surgical time for joint reconstruction
  3. Patients whose feasibility of joint preservation was not fulfill the above inclusion criteria at initial presentation, although the tumor size was decreased enough to fulfill the inclusion criteria in MRI after completion of neoadjuvant chemotherapy.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stryker navigation system

Arm Description

Outcomes

Primary Outcome Measures

Resection margin and safety
Pre-operative and post-operative CT or MRI images were fused using image fusion application of navigation software (Striker, Mahwah, NJ)in order to evaluate the resection margin.
Resection margin and safety
Pre-operative and post-operative CT or MRI images were fused using image fusion application of navigation software (Striker, Mahwah, NJ)in order to evaluate the resection margin.

Secondary Outcome Measures

Oncological outcome and functional score
1) Oncological outcome after 6 month or 12 month from surgery like patient survival or tumor recurrence (tumor recurrence was diagnosed with PET CT or MRI according to the nature of original tumor), 2) functional scores were assessed by evaluation systems of the Musculoskeletal Tumor Society (MSTS)and Toronto Extremity Salvage Score (TESS).

Full Information

First Posted
July 30, 2010
Last Updated
August 10, 2010
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01179698
Brief Title
Navigation Surgery for Bone and Soft Tissue Tumor
Official Title
Navigation Surgery for Bone and Soft Tissue Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bone tumor near the articular cartilage is hard to remove sufficiently without damaging adjacent joint. The purpose of this study was to evaluate the feasibility of navigation-assisted surgery for saving joint in bone tumor resection or curettage. In this study, the investigators hypothesized that computer-assisted surgery is feasible method to get both enough margin and joint salvage. Each of them is important intermediate factor for either oncologic outcome or functional outcome respectively. The investigators designed this study to find what proportion of patients who underwent computer-assisted resection could get enough margins using some criteria obtained by overlapping preoperative and postoperative images. The investigators also evaluated whether computer-assisted surgery can be feasible for joint saving using some criteria including functional outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumors
Keywords
computer-assisted surgery, bone tumor, We will evaluate whether computer-assisted surgery, will be feasible and safe for bone tumor resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stryker navigation system
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Navigation surgery
Intervention Description
In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
Intervention Type
Procedure
Intervention Name(s)
Navigation system
Intervention Description
In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
Primary Outcome Measure Information:
Title
Resection margin and safety
Description
Pre-operative and post-operative CT or MRI images were fused using image fusion application of navigation software (Striker, Mahwah, NJ)in order to evaluate the resection margin.
Time Frame
Day 1 - During operation
Title
Resection margin and safety
Description
Pre-operative and post-operative CT or MRI images were fused using image fusion application of navigation software (Striker, Mahwah, NJ)in order to evaluate the resection margin.
Time Frame
3 months - postoperative
Secondary Outcome Measure Information:
Title
Oncological outcome and functional score
Description
1) Oncological outcome after 6 month or 12 month from surgery like patient survival or tumor recurrence (tumor recurrence was diagnosed with PET CT or MRI according to the nature of original tumor), 2) functional scores were assessed by evaluation systems of the Musculoskeletal Tumor Society (MSTS)and Toronto Extremity Salvage Score (TESS).
Time Frame
Postoperative 6 month and 12month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: First condition is that the benign tumor is located deeply in bones of extremities, or pelvis, so we anticipate the difficulty to find the tumor and to assess the adequacy of resection without the aid of computer-assisted navigation during operation. Second condition is when the violation of joint or growth plate is expected during removal of tumor due to its close proximity to joint or growth plate. In case of malignant bone tumor, the sufficient preservation of joint anatomy should be required even with resection margin of 1.5 cm away from reactive zone of tumor. The sufficient preservation of joint is defined when at least 1 cm subchondral bone is remained after tumor resection, because 1 cm subchondral bone is required for fixation with allograft in subsequent reconstruction. The sufficient preservation of joint is also defined when articular surface is removed, but more than 50% of articular surface has to be saved. Exclusion criteria were Patients who denied to perform navigation surgery after explanation of navigation surgery protocol Medically high-risk patients who could not withstand long surgical time for joint reconstruction Patients whose feasibility of joint preservation was not fulfill the above inclusion criteria at initial presentation, although the tumor size was decreased enough to fulfill the inclusion criteria in MRI after completion of neoadjuvant chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Wook Seo
Ext
02-3410-1229
Email
sungwook.seo@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Jung Jin, bachelor's degree
Ext
02-3410-6799
Email
jin8077.jin@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Wook Seo
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-Dong
ZIP/Postal Code
50
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Wook Seo
Ext
02-3410-1229
First Name & Middle Initial & Last Name & Degree
Sung Wook Seo

12. IPD Sharing Statement

Learn more about this trial

Navigation Surgery for Bone and Soft Tissue Tumor

We'll reach out to this number within 24 hrs