Navigation Surgery for Bone and Soft Tissue Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179698
First received: July 30, 2010
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Bone Tumors
Procedure: Navigation surgery
Procedure: Navigation system

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Navigation Surgery for Bone and Soft Tissue Tumor

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Resection margin and safety [ Time Frame: Day 1 - During operation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months - postoperative ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Postoperative 6 month and 12month ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 45
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stryker navigation system Procedure: Navigation surgery
In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
Procedure: Navigation system
In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01179698

Contacts
Contact: Sung Wook Seo sungwook.seo@samsung.com
Contact: Hee Jung Jin, bachelor's degree jin8077.jin@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Irwon-Dong, Korea, Republic of, 50
Contact: Sung Wook Seo         
Principal Investigator: Sung Wook Seo         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sung Wook Seo Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sungwook Seo, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179698     History of Changes
Other Study ID Numbers: 2008-08-058
Study First Received: July 30, 2010
Last Updated: August 10, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
computer-assisted surgery
bone tumor
We will evaluate whether computer-assisted surgery
will be feasible and safe for bone tumor resection

Additional relevant MeSH terms:
Neoplasms
Bone Neoplasms
Soft Tissue Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 02, 2014