UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013131 |
|---|---|
| Receipt number | R000015313 |
| Scientific Title | Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial |
| Date of disclosure of the study information | 2014/02/11 |
| Last modified on | 2016/02/23 01:15:15 |
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Basic information
Public title
Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Acronym
Adding of knee flexion to fast-track rehabilitation
Scientific Title
Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Scientific Title:Acronym
Adding of knee flexion to fast-track rehabilitation
Region
| Europe |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
whether adding of flexion series would improve pain and knee function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KSS scores,VAS values, KOOS
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Twice series of multiple knee flexion within 2 hours after total knee arthroplasty
Interventions/Control_2
patients without any series of knee flexion within 6 hours after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
primary osteoarthrosis, adult patients and operated by the same surgeon
Key exclusion criteria
Patients are excluded if they are unable to complete the protocol or have rheumatoid arthritis, systemic or metabolic disorders, an American Society of Anesthesiologists (ASA) score of 3, previous major surgery on the affected joint, neurologic or psychiatric disease, or alcohol abuse.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University of Szczecin
Division name
Orthopaedics
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
+48914253238
paulz@wp.pl
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University in Szczecin
Division name
Orthopaedics
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
+48914253238
Homepage URL
paulz@wp.pl
Sponsor or person
Institute
Pomeranian Medical University in Szczecin
Institute
Department
Personal name
Funding Source
Organization
Self
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
| 2014 | Year | 02 | Month | 11 | 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
| 2014 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 11 | Day |
Last modified on
| 2016 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015313
