Total Knee ArthroplastyPhase 4NCT00485212
Compression Bandage in Local Infiltration Analgesia Afte Total Knee Arthroplasty
A Phase 4 study testing compression bandage in people with Total Knee Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- compression bandage
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- scheduled for total knee arthroplasty
- speak and understand Danish
Who cannot join
- severe obesity
- allergies to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Compression Bandage in Local Infiltration Analgesia After Total Knee Arthroplasty
purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty
Read the detailed description
patients are randomised to receive a compression bandage or a non-compression bandage
- Conditions
- Total Knee Arthroplasty
- Being tested
- compression bandage
- Keywords
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression bandageDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, Visual Analogue Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJan 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lasse Andersen, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485212
- Sponsor's protocol ID
- KF01327078
- Status last verified
- May 2007
- First submitted
- 11 Jun 2007
- Last updated
- 12 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Compression Bandage in Local Infiltration Analgesia After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00485212
- Acronym / sponsor ID
- KF01327078
- Conditions
- Total Knee Arthroplasty
- Keywords
- postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- May 2007 (actual)
- First posted
- 12 Jun 2007 (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.
purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty
Detailed description
patients are randomised to receive a compression bandage or a non-compression bandage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for total knee arthroplasty
- speak and understand Danish
Key exclusion criteria (2 listed)
- severe obesity
- allergies to local anaesthetics
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 |
|---|---|---|
| compression bandage | Device | – |
Primary outcome
pain, Visual Analogue Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2007.
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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.
Lasse Andersen, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing compression bandage in people with Total Knee 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 2 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: finished, as of the sponsor's last update on 12 Jun 2007. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain, Visual Analogue Scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2007.