UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Acronym	The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Scientific Title	The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Scientific Title:Acronym	The Effect of Alignment Change on Knee Joint Pressure Distribution in Unicompartmental Knee Arthroplasty
Region	Japan

Condition
Condition	Knee Osteoarthritis or Knee Osteonecrosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the effect of alignment changes on joint load distribution in Unicompartmental knee arthroplasty.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study was to predict osteoarthritis of the lateral epicondyle, sub-implant fractures, and tibial surface wear from changes in joint load distribution.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum pressure at the epicondylar joint surface of the tibia
Key secondary outcomes	Maximum pressure just below the tibial baseplate Maximum pressure on tibial surface

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	50 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have undergone unicompartmental knee replacement surgery for osteoarthritis or osteonecrosis of the femoral epicondyle and have given consent for this study.
Key exclusion criteria	Patients with missing preoperative and postoperative CT, 3T-MRI 3T 0.6 mm slice, or pre- and postoperative full-extremity standing simple x-rays
Target sample size	5

Research contact person
Name of lead principal investigator	1st name NATSUKI Middle name Last name SUGIMURA
Organization	Kochi university
Division name	Orthopaedics
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku city, Kochi
TEL	0888802386
Email	jm-snatsuki@kochi-u.ac.jp

Public contact
Name of contact person	1st name NATSUKI Middle name Last name SUGIMURA
Organization	Kochi university
Division name	Orthopeadics
Zip code	783-8505
Address	185-1 Oko-cho Kohasu
TEL	0888802386
Homepage URL
Email	sugimura.n@kochi-u.ac.jp

Sponsor
Institute	Dept. of Orthop., Kochi Uni.
Institute
Department

Funding Source
Organization	Dept. of Orthop., Kochi Uni.
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	Kochi university
Address	185-1 Oko-cho Kohasu
Tel	0888802386
Email	sugimura.n@kochi-u.ac.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	2021 Year 02 Month 08 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	2021 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 08 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	None in particular.

Management information
Registered date	2021 Year 02 Month 08 Day
Last modified on	2021 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049406