UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005748 |
|---|---|
| Receipt number | R000006799 |
| Scientific Title | CT-navigation-assisted surgery with skin marker for bone and soft tissue tumor |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2020/12/15 11:46:40 |
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Basic information
Public title
CT-navigation-assisted surgery with skin marker for bone and soft tissue tumor
Acronym
Navigation surgery for bone and soft tissue tumor
Scientific Title
CT-navigation-assisted surgery with skin marker for bone and soft tissue tumor
Scientific Title:Acronym
Navigation surgery for bone and soft tissue tumor
Region
| Japan |
Condition
Condition
Bone and soft tissue tumor
Classification by specialty
| Orthopedics | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate the accuracy and efficacy of CT navigation-assisted surgery for bone and soft tissue tumor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Histopathology(WHO classification) Grade(FNCLCC system)
2. Surgical procedure (Intralesion or wide)
3. Operation time (Preparation time of this method and actual operation time)
4. Blood loss, Size of skin incision
5. Registration error
6. Surgical margin of gross specimen
7. Pre- and Postoperative limb function (Enneking score, Musculiskeletal Tumor Society Score)
Pain score (Pre and post-operative)
8. Overall survival rate, Event free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We use commercially computer-assisted navigation system (SthealthStation Medtronic Sofamor Daneck CO, Ltd., Japan) for bone and soft tissue tumors. The system uses CT datasets of the region of interest. The registration procedure was performed using 10 skin markers provided by Medtronic Sofamor Danek CO Ltd. 10 skin marker were placed in the skin around the tumor. Before surgery, a CT scan was performed with the patient in a posture equivalent to that at a planned surgery. Data were acquired with a multislice CT scanner in 1-mm intervals. The patient's data were transferred to the navigation computer and reconstructed in 3D images on a monitor. The registration procedure was performed in the operationg room before staring the surgery., using sterile conditions. The accuracy of image-to-patient registration was called the registration error. The registration error was calculated by the navigation system. It was accepted a calulated error of less than the 2mm. After the registration was completed, the computer navigated surgery was started.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bone and soft tissue tumor with bone involvement
Metastaic bone tumor
Key exclusion criteria
Bone and soft tissue tumor without bone involvement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Hoshi |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-Machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3851
hoshi@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Hoshi |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-Machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3851
Homepage URL
hoshi@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Osaka City University Graduate School of Medicine
Address
1-2-7, Asahi-Machi, Abeno-ku, Osaka 545-8585, Japan
Tel
06-6645-3435
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
suspended
Number of participants that the trial has enrolled
10
Results
Pathology: Hemangioma 2cases, Solitary bone cyst 2cases Fibrous dysplasia 1case, Fibrolipoma 1 case, intraosseous ganglion 1 case, Chordoma 1 case, pelvic bone metastasis of GIST 1case, synovial cyst 1case.
Surgery: intralesional 9 case, Wide resection 1case
Registration error: Mean value 1.3 (1.1-2.2) mm
Anatomical site: Humerus 3 cases, Pelvis 3 cases, Tibia 2 cases, Tarus 1 case, Calcaneus 1 case.
Preparation time: mean value 37.5 min (28-58)min
Follow-up: No recurrence at the last fllow-up
Results date posted
| 2019 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Bone and soft tissue tumor
Cases in which tumor occupation range can not be easily identified by conventional imaging techniques during tumor resection
Participant flow
The doctor recruits the patient after diagnostic imaging
Adverse events
None
Outcome measures
Pathology
Surgical method
Registration error
Anatomical site
Tumor size
Operation time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2006 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 16 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006799
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