UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Title of the study (Brief title)	Effects of preoperative rehabilitation program on outcomes after TKA
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effectiveness of preoperative exercise with tibial internal rotation on improving knee kinematics and clinical outcomes after total knee arthroplasty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Knee joint kinematics
Key secondary outcomes	Knee flexion angle, WOMAC, SF-36

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Novel knee rehabilitation (3 months) (tibial internal-external rotation with knee bending, Leg flexion/extension with tibial internal-rotation, knee-out squat
Interventions/Control_2	Traditional knee rehabilitation(3 months) (quad setting, active straight leg raising, hip abduction, hip lift)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(a) Japanese males and females, (b) between 50 and 80 years old, (c) primary medial compartment knee osteoarthritis, (d) radiographic severity classified using Kellgren-Lawrence System was grade III to grade IV.
Key exclusion criteria	(a) lateral compartment knee osteoarthritis, (b) history of knee surgery, (c) receiving some kind of rehabilitation program, (d) subject who has a serious disease on knee joint, (e) history of rheumatoid arthritis, cerebropathy, neuropathy, gout.
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuyoshi Gamada
Organization	Graduate School of Hiroshima International University
Division name	Medical Technology and Health Welfare Sciences
Address	555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL	0823-70-4550
Email	kazgamada@ortho-pt.com

Public contact
Name of contact person	Kenji Hoshi
Organization	Graduate School of Hiroshima International University
Division name	Medical Technology and Health Welfare Sciences
Address	555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima
TEL	0823-70-4550
Homepage URL
Email	pt.hoshiken@gmail.com

Sponsor
Institute	Hiroshima International University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroshima Prefectural Rehabilitation Center
Name of secondary funｄer(s)

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	広島県立障害者リハビリテーションセンター（広島県）/広島県立障害者リハビリテーションセンター（広島県） / Hiroshima Prefectural Rehabilitation center（Hiroshima）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 11 Day
Anticipated trial start date	2012 Year 10 Month 03 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2017 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027856