UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024196
Receipt number R000027856
Scientific Title The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial
Date of disclosure of the study information 2016/09/28
Last modified on 2017/11/12 18:33:00

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Basic information

Public title

The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial

Acronym

Effects of preoperative rehabilitation program on outcomes after TKA

Scientific Title

The effects of pre-operative rehabilitation on clinical outcomes after knee arthroplasty: a randomized controlled trial

Scientific Title:Acronym

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

1st name
Middle name
Last name Kazuyoshi Gamada

Organization

Graduate School of Hiroshima International University

Division name

Medical Technology and Health Welfare Sciences

Zip code


Address

555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima

TEL

0823-70-4550

Email

kazgamada@ortho-pt.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Hoshi

Organization

Graduate School of Hiroshima International University

Division name

Medical Technology and Health Welfare Sciences

Zip code


Address

555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima

TEL

0823-70-4550

Homepage URL


Email

pt.hoshiken@gmail.com


Sponsor or person

Institute

Hiroshima International University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 09 Month 11 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027856


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name