UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012228
Receipt number R000014298
Scientific Title Effect of Adding One, 15-Minute Walk on the Day of Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Date of disclosure of the study information 2013/11/07
Last modified on 2013/12/10 06:28:39

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Basic information

Public title

Effect of Adding One, 15-Minute Walk on the Day of Surgery to Fast-Track Rehabilitation after Total Knee
Arthroplasty in Elderly Patients: A Randomized Trial

Acronym

A comparison of fast-track rehabilitation protocols.

Scientific Title

Effect of Adding One, 15-Minute Walk on the Day of Surgery to Fast-Track Rehabilitation after Total Knee
Arthroplasty in Elderly Patients: A Randomized Trial

Scientific Title:Acronym

A comparison of fast-track rehabilitation protocols.

Region

Europe


Condition

Condition

knee arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to compare a fast-track rehabilitation protocol of two different intensities started on the day of the operation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

not yet

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

fast-track rehabilitation

Interventions/Control_2

intensive fast-track rehabilitation

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with IV degree of primary osteoarthrosis (according to Kellgren and Lawrence) who underwent TKA

Key exclusion criteria

lack of cooperation capability, rheumatoid arthritis, systemic or metabolic disorders, American Society of Anesthesiologists (ASA) score grading of 3, previous major surgery on the affected joint, neurologic or psychiatric disease, alcohol.

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

Department of Orthopaedics

Zip code


Address

ul. Unii Lubelskiej 1,Szczecin, Poland

TEL

+48914253238

Email

paulz@wp.pl


Public contact

Name of contact person

1st name
Middle name
Last name Zietek

Organization

Pomeranian Medical University

Division name

Department of Orthopaedics

Zip code


Address

ul. Unii Lubelskiej 1, Szczecin, Poland

TEL

+48914253238

Homepage URL


Email

paulz@wp.pl


Sponsor or person

Institute

Zietek

Institute

Department

Personal name



Funding Source

Organization

self

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


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



Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 07 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

The final sample consisted of 17 patients in the intensive protocol (mean age, 72 years) and 21 in the standard protocol (mean age, 70 years)
On the first postoperative day, while walking, 13 patients on the intensive protocol and 14 on the standard protocol reported moderate-to-severe pain.On the second day, 13 and 15 patients, respectively, again reported moderate-to-severe pain. Mean pain scores did not differ significantly between groups on any of the followup days

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 11 Month 07 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 07 Day

Last follow-up date

2013 Year 12 Month 08 Day

Date of closure to data entry

2013 Year 12 Month 08 Day

Date trial data considered complete

2013 Year 12 Month 08 Day

Date analysis concluded

2013 Year 12 Month 09 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 07 Day

Last modified on

2013 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name