Navigation Surgery for Bone and Soft Tissue Tumor

Not Applicable

• Conditions: Bone Tumors
• Interventions: Procedure: Navigation surgery; Procedure: Navigation system

• Registration Number: NCT01179698
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-07-30
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-10
• Last Update Submitted: 2010-08-10
• Study First Posted: 2010-08-11
• Last Update Posted: 2010-08-11
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stryker navigation system	Navigation surgery	-
Stryker navigation system	Navigation system	-

Primary Outcome Measures

Name	Time	Method
Resection margin and safety	3 months - postoperative	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

Name	Time	Method
Oncological outcome and functional score	Postoperative 6 month and 12month	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).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-Dong, Korea, Republic of