Knee Joint Icing and Knee-extension Strength
IS
No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 19, 2012
July 1, 2012
7 months
November 23, 2010
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Knee pain
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
Study Arms (2)
Control treatment
PLACEBO COMPARATORElbow joint icing using two plastic bags with crushed ice
Active treatment
ACTIVE COMPARATORKnee joint icing using two plastic bags with crushed ice
Interventions
Eligibility Criteria
You may qualify if:
- primary unilateral total knee arthroplasty
You may not qualify if:
- inability to speak and understand Danish
- inability to perform the measurements due to other diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- Lundbeck Foundationcollaborator
Study Sites (1)
The Lundbeckcenter for fast-track hip and knee surgery
Copenhagen, Hvidovre, 2650, Denmark
Related Publications (1)
Holm B, Husted H, Kehlet H, Bandholm T. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study. Clin Rehabil. 2012 Aug;26(8):716-23. doi: 10.1177/0269215511432017. Epub 2012 Jan 19.
PMID: 22261815DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bente Holm, MSc
Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc PT
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 30, 2010
Study Start
April 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
July 19, 2012
Record last verified: 2012-07