UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040018 |
|---|---|
| Receipt number | R000045622 |
| Scientific Title | Effect of posterior condyle resection volume in unicompartmental knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/10/18 15:38:48 |
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Basic information
Public title
Effect of posterior condyle resection volume in unicompartmental knee arthroplasty: a randomized controlled trial
Acronym
Effect of posterior condyle resection volume in unicompartmental knee arthroplasty: a randomized controlled trial
Scientific Title
Effect of posterior condyle resection volume in unicompartmental knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Effect of posterior condyle resection volume in unicompartmental knee arthroplasty: a randomized controlled trial
Region
| Japan |
Condition
Condition
knee osteoarthritis; spontaneous osteonecrosis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of posterior condyle resection volume in unicompartmental knee arthroplasty 2 years after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WOMAC
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Femoral posterior condyle resection volume (Normal resection volume)
Interventions/Control_2
Femoral posterior condyle resection volume (Additional resection volume)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing unicompartmental knee arthroplasty for knee osteoarthritis and spontaneous osteonecrosis of the knee
Key exclusion criteria
Patients with implant loosening or infection
Patients with knee contracture more than 15 degrees
Patients with restricted flexion more than 120 degrees
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ogawa |
Organization
Ogaki Tokushukai Hospital
Division name
Orthopaedic Surgery
Zip code
503-0015
Address
Hayashi-machi 6-85-1, Ogaki, Gifu, Japan
TEL
0584-77-6110
hiroyasu.ogawa@tokushukai.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ogawa |
Organization
Ogaki Tokushukai Hospital
Division name
Orthopaedic Surgery
Zip code
503-0015
Address
Hayashi-machi 6-85-1, Ogaki, Gifu, Japan
TEL
0584-77-6110
Homepage URL
hiroyasu.ogawa@tokushukai.jp
Sponsor or person
Institute
Ogaki Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogaki Tokushukai Hospital
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
mirai-iryo-kenkyucenter
Address
kouji-machi1-8-7, tiyoda-ku, tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045622
