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Clinical Trials/NCT01179698
NCT01179698UnknownNot Applicable

Navigation Surgery for Bone and Soft Tissue Tumor

Samsung Medical Center2 sites in 1 country45 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
45
Locations
2
Primary Endpoint
Resection margin and safety

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Resection margin and safety

Time Frame: 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 Outcomes

  • Oncological outcome and functional score(Postoperative 6 month and 12month)

Investigators

Sponsor Class
Other

Study Sites (2)

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