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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01249612
Other study ID # (H-A-2008-063, nr. 24100
Secondary ID TKA-BH3
Status Terminated
Phase Phase 1
First received November 23, 2010
Last updated July 18, 2012
Start date April 2010
Est. completion date December 2010

Study information

Verified date July 2012
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.


Description:

As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- primary unilateral total knee arthroplasty

Exclusion Criteria:

- inability to speak and understand Danish

- inability to perform the measurements due to other diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Thermotherapy
Knee joint icing
Thermotherapy
Elbow joint icing

Locations

Country Name City State
Denmark The Lundbeckcenter for fast-track hip and knee surgery Copenhagen Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee-extension strength Maximal knee-extension strength is measured using a hand-held dynamometer In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment No
Secondary Knee pain Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements. In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment No
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