UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052775 |
|---|---|
| Receipt number | R000060223 |
| Scientific Title | Investigation of postoperative target alignment in robot-assist TKA |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2023/11/12 18:38:38 |
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Basic information
Public title
Investigation of postoperative target alignment in robot-assist TKA
Acronym
Investigation of postoperative target alignment in robot-assist TKA
Scientific Title
Investigation of postoperative target alignment in robot-assist TKA
Scientific Title:Acronym
Investigation of postoperative target alignment in robot-assist TKA
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the optimal target alignment for good postoperative results of robotic joint prostheses.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of Western Ontario and McMaster Universities Osteoarthritis Index (Womac score) at 1 year postoperatively between groups
Key secondary outcomes
Japanese Knee Arthroplasty Association Knee Disease Evaluation Criteria (JOA score), Knee Injury and Osteoarthritis Outcome Score (KOOS score), Western Ontario and McMaster Universities Osteoarthritis Index (Womac score), Forgotten jont score (FJS score), EQ5D score at 1 year after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mechanical Alignment
Interventions/Control_2
Kinematic Alignment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing knee replacement surgery at our hospital
Key exclusion criteria
When the principal investigator determines that the patient has a significant lower limb deformity due to trauma or degeneration
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | AKIRA |
| Middle name | |
| Last name | MAEYAMA |
Organization
Fukuoka University
Division name
Department of Orthopaedic Surgery,Faculty of medicine
Zip code
8140180
Address
7-45-1 Nanakuma,Jonan-ku,Fukuoka 814-0180 JAPAN
TEL
09018707071
akira.maeyama0713@joy.ocn.ne.jp
Public contact
Name of contact person
| 1st name | AKIRA |
| Middle name | |
| Last name | MAEYAMA |
Organization
Fukuoka University
Division name
Department of Orthopaedic Surgery,
Zip code
814018
Address
7-45-1 Nanakuma,Jonan-ku,Fukuoka 814-0180 JAPAN
TEL
0928011011
Homepage URL
akira.maeyama0713@joy.ocn.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,Faculty of medicine,Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Orthopaedic Surgery, Faculty of medicine,Fukuoka University
Address
7-45-1 Nanakuma,Jonan-ku,Fukuoka 814-0180 JAPAN
Tel
0928011011
akira.maeyama0713@joy.ocn.ne.jp
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
| 2024 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060223
