UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004646 |
|---|---|
| Receipt number | R000005530 |
| Scientific Title | Comparison Between Resection and Arthrodesis of the First MTP Joint for Rheumatoid Forefoot |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2015/06/01 09:04:38 |
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Basic information
Public title
Comparison Between Resection and Arthrodesis of the First MTP Joint for Rheumatoid Forefoot
Acronym
Comparison Between Resection and Arthrodesis of the First MTP Joint for Rheumatoid Forefoot
Scientific Title
Comparison Between Resection and Arthrodesis of the First MTP Joint for Rheumatoid Forefoot
Scientific Title:Acronym
Comparison Between Resection and Arthrodesis of the First MTP Joint for Rheumatoid Forefoot
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most of patients with rheumatoid arthritis have problems with their feet. The painful, deformed rheumatoid forefoot may be treated with resection of the lesser metatarsal heads combined with either arthrodesis or resection of the first metatarsophalangeal (MTP) joint. Good results have been observed in previous surgical procedures. Recurrent deformity of both the hallux valgus (HV) and lesser toes were reported, when the HV deformity was managed by resection. This criticism, however, was based on historical observation from previous studies. There was no prospective or randomized study. So we performed the prospective, randomized, internal-controlled clinical study. To compare the clinical results of arthrodesis and resection of the first MTP joint in simultaneous operation for same patient who had the painful, deformed rheumatoid forefoot.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical results (AOFAS score)
Radiographic evaluation (hallux valgus angle, M1M2 angle, and M1M5 angle)
Recurrence rate (hallux valgus, crow toe, and callosities)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Arthrodesis of the first metatarsophalangeal joint
Interventions/Control_2
Resection of the first metatarsophalangeal joint
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rheumatoid arthritis patinets according to creiteria of America Collage of Rheumatology
Patients of bilateral forefoot deformities (hallux valgus, crow toe)
Key exclusion criteria
Patients of unilateral forefoot deformities (hallux valgus, crow toe)
Patients perfermed surgery for forefoot deformities
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tada |
Organization
Osaka City University Medical School
Division name
Orthopaedic Surgery
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-3852
m-tada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Tada |
Organization
Osaka City University Medical School
Division name
Orthopaedic Surgery
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, Japan
TEL
06-6645-3852
Homepage URL
m-tada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School, Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005530
