Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
pain [ Time Frame: daily until day 7 after surgery ]
Pain on Visual Analog Scale
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
pain [ Time Frame: daily until day 7 after surgery ]
Pain on VAS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • analgetics [ Time Frame: daily until day 7 after surgery ]
    Use of additional analgetics
  • Mobility [ Time Frame: daily until day 7 after surgery ]
    grade of mobility
  • Function [ Time Frame: preoperative, 3 month, 1 year ]
    Knee Society Score
  • Patient reported outcome [ Time Frame: preoperative, 3 month, 1 year ]
    Oxford Knee Score
  • Quality of Life [ Time Frame: preoperative, 3 month, 1 year ]
    EQ 5D
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Control After Total Knee Arthroplasty
Official Title  ICMJE Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Regional pain control
    Regional pain catheter
  • Procedure: Local pain control
    Local intraarticular pain catheter
Study Arms  ICMJE
  • Active Comparator: Regional pain control
    Regional pain catheter
    Intervention: Procedure: Regional pain control
  • Experimental: Local pain control
    Local intraarticular pain catheter
    Intervention: Procedure: Local pain control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Indication to Total Knee Arthroplasty
  • Signed informed consent

Exclusion Criteria:

  • Chronic pain
  • Allergy against local anaesthetics
  • Not understanding study or questionnaires
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032133
Other Study ID Numbers  ICMJE TKA pain
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Technische Universität Dresden
Study Sponsor  ICMJE Technische Universität Dresden
Collaborators  ICMJE Mathys Ltd Bettlach
Investigators  ICMJE
Principal Investigator: Jörg Lützner, MD TU Dresden
PRS Account Technische Universität Dresden
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP