UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005748
Receipt No. 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 2019/06/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hoshi@med.osaka-cu.ac.jp

Sponsor
Institute Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

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
Email 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
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
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.