An interventional study of Navigation surgery and Navigation system in Bone Tumors, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2010-08-11.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
321 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 217 interventional studies indexed under Bone Neoplasms.
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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
Procedure: Navigation surgery · 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.
In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
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.
Time frame: 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.
Time frame: 3 months - postoperative
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).
Time frame: Postoperative 6 month and 12month
This study is status unknown, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center