Knee OsteoarthritisNCT03032133
Pain Control After Total Knee Arthroplasty
A study of Knee Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Dec 2018
- Phase
- Interventional
- 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
- Indication to Total Knee Arthroplasty
- Signed informed consent
Who cannot join
- Chronic pain
- Allergy against local anaesthetics
- Not understanding study or questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.
- Conditions
- Knee Osteoarthritis
- Being tested
- Regional pain control, Local pain control
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Results, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional pain controlProcedure or surgery
Regional pain catheter
Local pain controlProcedure or surgery
Local intraarticular pain catheter
| Study group | Role | What they receive |
|---|---|---|
| Regional pain control | Active comparator | Regional pain catheter Receives: Procedure: Regional pain control |
| Local pain control | Experimental | Local intraarticular pain catheter Receives: Procedure: Local pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Pain on Visual Analog Scale
Measured: daily until day 7 after surgery
Secondary outcomes (5)
analgetics
Use of additional analgetics
Measured: daily until day 7 after surgery
Mobility
grade of mobility
Measured: daily until day 7 after surgery
Function
Knee Society Score
Measured: preoperative, 3 month, 1 year
Patient reported outcome
Oxford Knee Score
Measured: preoperative, 3 month, 1 year
Quality of Life
EQ 5D
Measured: preoperative, 3 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2018
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 Technische Universität DresdenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Mathys Ltd Bettlach
- Responsible party
- Sponsor
- Investigators
- Jörg Lützner, MD, Principal investigator, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032133
- Sponsor's protocol ID
- TKA pain
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
- ClinicalTrials.gov ID
- NCT03032133
- Acronym / sponsor ID
- TKA pain
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Outcome, Results, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Mathys Ltd Bettlach
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 Jan 2017 (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.
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional pain control | Active comparator | Procedure: Regional pain controlRegional pain catheter |
| Local pain control | Experimental | Procedure: Local pain controlLocal intraarticular pain catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication to Total Knee Arthroplasty
- Signed informed consent
Key exclusion criteria (3 listed)
- Chronic pain
- Allergy against local anaesthetics
- Not understanding study or questionnaires
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 |
|---|---|---|
| Regional pain controlRegional pain catheter | Procedure or surgery | Regional pain control |
| Local pain controlLocal intraarticular pain catheter | Procedure or surgery | Local pain control |
Primary outcome
pain
Time frame: daily until day 7 after surgery
Pain on Visual Analog Scale
5 secondary outcomes
analgetics
Time frame: daily until day 7 after surgery
Mobility
Time frame: daily until day 7 after surgery
Function
Time frame: preoperative, 3 month, 1 year
Patient reported outcome
Time frame: preoperative, 3 month, 1 year
Quality of Life
Time frame: preoperative, 3 month, 1 year
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 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Jörg Lützner, MD principal investigator
TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Knee Osteoarthritis, run by Technische Universität Dresden at 1 site in Germany.
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 3 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 Feb 2019. 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 Germany. 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: daily until day 7 after surgery). 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 Feb 2019.