Knee Osteoarthritis Clinical Trial
Official title:
Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
| NCT number | NCT03032133 |
| Other study ID # | TKA pain |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 2016 |
| Est. completion date | December 2018 |
| Verified date | February 2019 |
| Source | Technische Universität Dresden |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Indication to Total Knee Arthroplasty - Signed informed consent Exclusion Criteria: - Chronic pain - Allergy against local anaesthetics - Not understanding study or questionnaires |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklinikum Carl Gustav Carus | Dresden |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität Dresden | Mathys Ltd Bettlach |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain | Pain on Visual Analog Scale | daily until day 7 after surgery | |
| Secondary | analgetics | Use of additional analgetics | daily until day 7 after surgery | |
| Secondary | Mobility | grade of mobility | daily until day 7 after surgery | |
| Secondary | Function | Knee Society Score | preoperative, 3 month, 1 year | |
| Secondary | Patient reported outcome | Oxford Knee Score | preoperative, 3 month, 1 year | |
| Secondary | Quality of Life | EQ 5D | preoperative, 3 month, 1 year |
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