Status:
UNKNOWN
Navigation Surgery for Bone and Soft Tissue Tumor
Lead Sponsor:
Samsung Medical Center
Conditions:
Bone Tumors
Eligibility:
All Genders
Phase:
NA
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 sav...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- First condition is that the benign tumor is located deeply in bones of extremities, or pelvis, so we anticipate the difficulty to find the tumor and to assess the adequacy of resection without the aid of computer-assisted navigation during operation.
- Second condition is when the violation of joint or growth plate is expected during removal of tumor due to its close proximity to joint or growth plate.
- 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
- Patients who denied to perform navigation surgery after explanation of navigation surgery protocol
- Medically high-risk patients who could not withstand long surgical time for joint reconstruction
- Patients whose feasibility of joint preservation was not fulfill the above inclusion criteria at initial presentation, although the tumor size was decreased enough to fulfill the inclusion criteria in MRI after completion of neoadjuvant chemotherapy.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01179698
Start Date
January 1 2009
End Date
December 1 2010
Last Update
August 11 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, Irwon-Dong, South Korea, 50