UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012646 |
|---|---|
| Receipt number | R000014790 |
| Scientific Title | TNFa as predictor of early postoperative knee function and pain in fast-track total knee arthroplasty patients. |
| Date of disclosure of the study information | 2013/12/21 |
| Last modified on | 2014/10/14 19:28:37 |
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Basic information
Public title
TNFa as predictor of early postoperative knee function and pain in fast-track total knee arthroplasty patients.
Acronym
Predictors of postoperative knee function and pain
Scientific Title
TNFa as predictor of early postoperative knee function and pain in fast-track total knee arthroplasty patients.
Scientific Title:Acronym
Predictors of postoperative knee function and pain
Region
| Europe |
Condition
Condition
Osteoarthriris
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of the study was to examine for cytokine and cartilage markers in preoperative knee synovial fluid (SF) as predictors of early postoperative pain in outpatient and short-stay total knee arthroplasty patients.
Basic objectives2
Others
Basic objectives -Others
We hypothesized that patients complaining of moderate/severe pain up to 2 weeks after TKA would have a higher level of preoperative anxiety compared with those who feel mild or no pain.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is ELISA test used to determine the levels of cartilage oligomeric matrix protein (COMP) and tumor necrosis factor-alpha.
Key secondary outcomes
The secondary outcome is anxiety assessed with the Spielberger State-Trait Anxiety Inventory state (STAI-S) and trait (STAI-T) scores.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elisa test. Questionnaires assessing level of preoperational anxiety were administered during interviews and were completed the same day by all patients.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients are eligible for the study if they have Kellgren and Lawrence radiographic stage IV primary osteoarthrosis, are scheduled to undergo TKA from the orthopedic department of Pomeranian Medical University, are adults; and will be operated by the same surgeon
Key exclusion criteria
The exclusion criteria are lack of cooperation capability, revision surgery for TKA, rheumatoid arthritis, systemic or metabolic disorders, neurologic or psychiatric disease, alcohol abuse, patients younger than 18 and older than 80 years.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University
Division name
Pomeranian Medical University
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
Pomeranian Medical University in Szczecin
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
+48914253238
Homepage URL
paulz@wp.pl
Sponsor or person
Institute
Zietek
Institute
Department
Personal name
Funding Source
Organization
Own
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
| 2013 | Year | 12 | Month | 21 | 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
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 21 | 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
| 2013 | Year | 12 | Month | 21 | Day |
Last modified on
| 2014 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014790
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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