NCT01179698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

1.9 years

First QC Date

July 30, 2010

Last Update Submit

August 10, 2010

Conditions

Bone Tumors

Keywords

computer-assisted surgerybone tumorWe will evaluate whether computer-assisted surgerywill be feasible and safe for bone tumor resection

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months - postoperative

Secondary Outcomes (1)

  • Oncological outcome and functional score

    Postoperative 6 month and 12month

Study Arms (1)

Stryker navigation system

OTHER
Procedure: Navigation surgeryProcedure: Navigation system

Interventions

Navigation surgeryPROCEDURE

In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.

Stryker navigation system
Navigation systemPROCEDURE

In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.

Stryker navigation system

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Irwon-Dong, 50, South Korea

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Surgery, Computer-AssistedSurgical Navigation Systems

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeSurgical EquipmentEquipment and Supplies

Study Officials

  • Sung Wook Seo

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Wook Seo

CONTACT

sungwook.seo@samsung.com

Hee Jung Jin, bachelor's degree

CONTACT

jin8077.jin@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 11, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations

KR(1)