UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032772 |
|---|---|
| Receipt number | R000037387 |
| Scientific Title | A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2018/05/30 11:01:19 |
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Basic information
Public title
A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Acronym
A leg press exercise restoring screw-home movement improves short-term clinical outcomes after OWHTO
Scientific Title
A leg press exercise restoring screw-home movement improves short-term clinical outcomes after opening wedge high tibial osteotomy
Scientific Title:Acronym
A leg press exercise restoring screw-home movement improves short-term clinical outcomes after OWHTO
Region
| Japan |
Condition
Condition
Opening wedge high tibial osteotomy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of postoperative exercise with tibial internal rotation on improving clinical outcomes after opening wedge high tibial osteotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of patient who achieved unsupported gait at one month postoperatively
Key secondary outcomes
WOMAC, gait speed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exercise with tibial internal rotation (1 months) (tibial internal-external rotation with knee bending, Leg flexion/extension with tibial internal-rotation)
10 repetitions*5 sets
Interventions/Control_2
Traditional knee rehabilitation(1 months)
(Straight leg raising exercise with maximal quadriceps setting)
10 repetitions*5 sets
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) Japanese males and females, (b) between 40 and 80 years old, (c) extension deficit<10 degrees, (d) radiographic severity classified using Kellgren-Lawrence System was grade II to III, (e) agreement of undergoing OWHTO
Key exclusion criteria
(a) history of a lower extremity trauma, (b) rheumatoid arthritis, (c) medical risk, and (d) postoperative compartment syndrome after HTO
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Gamada |
Organization
Graduate School of Hiroshima International University
Division name
Department of Medical Technology and Health Welfare Sciences
Zip code
Address
555-36, Kurosegakuendai, Higashihiroshima
TEL
+81823704550
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hoshi |
Organization
Graduate School of Hiroshima International University
Division name
Department of Medical Technology and Health Welfare Sciences
Zip code
Address
555-36, Kurosegakuendai, Higashihiroshima
TEL
+81823704550
Homepage URL
pt.hoshiken@gmail.com
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka Rehabilitation Hospital
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
福岡リハビリテーション病院（福岡県）
Fukuoka Rehabilitation Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037387
