Navigation Surgery for Bone and Soft Tissue Tumor

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.

Study Overview

• Status: Unknown
• Conditions: Bone Tumors
• Intervention / Treatment: Procedure: Navigation surgery; Procedure: Navigation system

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung Wook Seo; Email: sungwook.seo@samsung.com
• Study Contact Backup: Name: Hee Jung Jin, bachelor's degree; Email: jin8077.jin@samsung.com

Study Locations

• Korea, Republic of
  • Irwon-Dong
    • Seoul, Irwon-Dong, Korea, Republic of, 50
      • Recruiting
      • Samsung Medical Center
      • Contact: Sung Wook Seo
      • Principal Investigator: Sung Wook Seo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 - During operation
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.	3 months - postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Postoperative 6 month and 12month

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Sung Wook Seo, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: 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; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms; Soft Tissue Neoplasms
• Other Study ID Numbers: 2008-08-058