Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR

This study has been completed.

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00878358

First received: April 7, 2009

Last updated: April 27, 2011

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 7, 2009
Last Updated Date	April 27, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2009)	Timed up and go test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00878358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2009)	Oxford knee score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Visual analogue pain score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Range of knee motion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR
Official Title ^ICMJE	Hydrotherapy Versus Physiotherapy for Short-term Rehabilitation After Primary TKR
Brief Summary	Primary objective: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group. Secondary objectives: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group based on measurements of timed up and go (TUG, as primary outcome), range of motion, pain and quality of life.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis Total Knee Replacement
Intervention ^ICMJE	Other: Hydrotherapy Other: Physiotherapy
Study Arm (s)	Active Comparator: Physiotherapy Intervention: Other: Physiotherapy Experimental: Hydrotherapy Intervention: Other: Hydrotherapy
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	June 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Candidates for first total knee replacement surgery. Age over 18. Diagnosed with Osteoarthritis. Consent to participate in the trial. Exclusion Criteria: - Rheumatic diseases. Neurological diseases involving lower limbs. Prior knee surgery in operated knee. Secreting surgical wound. Skin diseases. Incontinence. Incapable of signing informed consent. Patients living outside Jerusalem
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00878358
Other Study ID Numbers ^ICMJE	Hydrotherapy-HMO-CTIL
Has Data Monitoring Committee	No
Responsible Party	Leonid Kandel, Hadassah Medical Center
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hadassah Medical Organization
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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