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Pain Control After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032133
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Mathys Ltd Bettlach
Information provided by (Responsible Party):
Technische Universität Dresden

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Regional pain control Procedure: Local pain control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regional pain control
Regional pain catheter
Procedure: Regional pain control
Regional pain catheter

Experimental: Local pain control
Local intraarticular pain catheter
Procedure: Local pain control
Local intraarticular pain catheter




Primary Outcome Measures :
  1. pain [ Time Frame: daily until day 7 after surgery ]
    Pain on Visual Analog Scale


Secondary Outcome Measures :
  1. analgetics [ Time Frame: daily until day 7 after surgery ]
    Use of additional analgetics

  2. Mobility [ Time Frame: daily until day 7 after surgery ]
    grade of mobility

  3. Function [ Time Frame: preoperative, 3 month, 1 year ]
    Knee Society Score

  4. Patient reported outcome [ Time Frame: preoperative, 3 month, 1 year ]
    Oxford Knee Score

  5. Quality of Life [ Time Frame: preoperative, 3 month, 1 year ]
    EQ 5D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication to Total Knee Arthroplasty
  • Signed informed consent

Exclusion Criteria:

  • Chronic pain
  • Allergy against local anaesthetics
  • Not understanding study or questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032133


Locations
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Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Mathys Ltd Bettlach
Investigators
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Principal Investigator: Jörg Lützner, MD TU Dresden
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03032133    
Other Study ID Numbers: TKA pain
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technische Universität Dresden:
Total Knee Arthroplasty
Total Knee Replacement
Outcome
Results
Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases