Navigation Surgery for Bone and Soft Tissue Tumor
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|ClinicalTrials.gov Identifier: NCT01179698|
Recruitment Status : Unknown
Verified August 2010 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Bone Tumors||Procedure: Navigation surgery Procedure: Navigation system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Navigation Surgery for Bone and Soft Tissue Tumor|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
|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.
- Resection margin and safety [ Time Frame: Day 1 - During operation ]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 ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179698
|Contact: Sung Wook Seoemail@example.com|
|Contact: Hee Jung Jin, bachelor's firstname.lastname@example.org|
|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|