Knee OsteoarthritisNCT02254499
Prediction of Pain After Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Sep 2015
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with knee osteoarthritis referred for total knee arthroplasty.
Who may be able to join
- primary unilateral TKA
- caucasian
- 50 - 80 years
- osteoarthritis
Who cannot join
- deficient written or spoken danish
- impairment from psychological og neurological disease
- expected discharged to rehabilitation facility
- anticoagulant therapy
- allergies to analgesic treatment
- hypertension (systolic > 160 / diastolic > 100)
- ASA class ≥ 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)
Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery
Measured: 24 hours postoperatively
Secondary outcomes (2)
Pain
Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery
Measured: 48 hours postoperatively
Pain
Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty.
Measured: From day 1 to day 14 following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Iben Engelund Luna, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254499
- Sponsor's protocol ID
- H-3-2014-090
- Status last verified
- Sep 2015
- First submitted
- 29 Sep 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT02254499
- Acronym / sponsor ID
- H-3-2014-090
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Oct 2014 (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.
Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis referred for total knee arthroplasty.
Key inclusion criteria (4 listed)
- primary unilateral TKA
- caucasian
- 50 - 80 years
- osteoarthritis
Key exclusion criteria (7 listed)
- deficient written or spoken danish
- impairment from psychological og neurological disease
- expected discharged to rehabilitation facility
- anticoagulant therapy
- allergies to analgesic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain
Time frame: 24 hours postoperatively
Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery
2 secondary outcomes
Pain
Time frame: 48 hours postoperatively
Pain
Time frame: From day 1 to day 14 following surgery
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 23 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Copenhagen University Hospital, Rigshospitalet 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 4 inclusion and 7 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 23 Sep 2015. 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.
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 (time frame: 24 hours postoperatively). 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 23 Sep 2015.