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Navigation Surgery for Bone and Soft Tissue Tumor

Open (Enrolling)
Bone Tumors

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Trial Information

Navigation Surgery for Bone and Soft Tissue Tumor

Inclusion 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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Resection margin and safety

Outcome 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.

Outcome Time Frame:

Day 1 - During operation

Safety Issue:


Principal Investigator

Sung Wook Seo

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


South Korea: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

December 2010

Related Keywords:

  • Bone Tumors
  • computer-assisted surgery
  • bone tumor
  • We will evaluate whether computer-assisted surgery
  • will be feasible and safe for bone tumor resection
  • Bone Neoplasms
  • Soft Tissue Neoplasms