ArthroplastyPhase 1ISNCT01249612
Knee Joint Icing and Knee-extension Strength
A Phase 1 study testing Thermotherapy in people with Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Thermotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary unilateral total knee arthroplasty
Who cannot join
- inability to speak and understand Danish
- inability to perform the measurements due to other diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Lundbeckcenter for fast-track hip and knee surgery
Copenhagen, Hvidovre, 2650
About this study
Official title: No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study
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.
Read the detailed 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.
- Conditions
- Arthroplasty
- Being tested
- Thermotherapy
- Keywords
- Knee joint icing, knee-extension strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermotherapyOther
Also called Cryotherapy
Knee joint icing
ThermotherapyOther
Also called Cryotherapy
Elbow joint icing
| Study group | Role | What they receive |
|---|---|---|
| Control treatment | Placebo comparator | Elbow joint icing using two plastic bags with crushed ice Receives: Other: Thermotherapy |
| Active treatment | Active comparator | Knee joint icing using two plastic bags with crushed ice Receives: Other: Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee-extension strength
Maximal knee-extension strength is measured using a hand-held dynamometer
Measured: 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
Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Bente Holm, Hvidovre University Hospital
- Investigators
- Bente Holm, MSc, Principal investigator, Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249612
- Sponsor's protocol ID
- (H-A-2008-063, nr. 24100
- Other IDs
- TKA-BH3
- Acronym
- IS
- Status last verified
- Jul 2012
- First submitted
- 23 Nov 2010
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22261815
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT01249612
- Acronym / sponsor ID
- IS / (H-A-2008-063, nr. 24100
- Conditions
- Arthroplasty
- Keywords
- Knee joint icing, knee-extension strength
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control treatment | Placebo comparator | Other: ThermotherapyElbow joint icing using two plastic bags with crushed ice |
| Active treatment | Active comparator | Other: ThermotherapyKnee joint icing using two plastic bags with crushed ice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary unilateral total knee arthroplasty
Key exclusion criteria (2 listed)
- inability to speak and understand Danish
- inability to perform the measurements due to other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermotherapyAlso: CryotherapyKnee joint icing | Other | Active treatment |
| ThermotherapyAlso: CryotherapyElbow joint icing | Other | Control treatment |
Primary outcome
Knee-extension strength
Time frame: 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
Maximal knee-extension strength is measured using a hand-held dynamometer
1 secondary outcome
Knee pain
Time frame: 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Derived from this study: PubMed 22261815Holm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Holm, MSc principal investigator
Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thermotherapy in people with Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee-extension strength (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.