Navigation Surgery for Bone and Soft Tissue Tumor
Recruitment status was Recruiting
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:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Navigation Surgery for Bone and Soft Tissue Tumor|
- Resection margin and safety [ Time Frame: Day 1 - During operation ] [ Designated as safety issue: Yes ]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.
- Resection margin and safety [ Time Frame: 3 months - postoperative ] [ Designated as safety issue: Yes ]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.
- Oncological outcome and functional score [ Time Frame: Postoperative 6 month and 12month ] [ Designated as safety issue: No ]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).
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179698
|Contact: Sung Wook Seofirstname.lastname@example.org|
|Contact: Hee Jung Jin, bachelor's email@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Irwon-Dong, Korea, Republic of, 50|
|Contact: Sung Wook Seo|
|Principal Investigator: Sung Wook Seo|
|Principal Investigator:||Sung Wook Seo||Samsung Medical Center|