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Evaluation of a Fast-track Knee Arthroplasty Concept (KneeOptOut)

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: NCT03114306
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE March 27, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE April 5, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
time to first mobilisation (standing) [ Time Frame: up to 48h postoperatively ]
time from end of surgery until patients is able to stand
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • patients satisfaction (11-point likert scale) [ Time Frame: up to 7 days postoperatively ]
    global satisfaction of patients
  • time to first mobilisation (walking) [ Time Frame: up to 7 days postoperatively ]
    time from end of surgery until patients is able to walk
  • complications [ Time Frame: up to 7 days postoperatively ]
    complications during perioperative care process (e.g. thrombosis, re-operation, infection)
  • time to achieve full joint mobility [ Time Frame: up to 7 days postoperatively ]
    time to achieve full joint mobility (0/0/90°)
  • pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean) [ Time Frame: up to 7 days postoperatively ]
    mean pain intensity of patients
  • rescue pain medication [ Time Frame: up to 7 days postoperatively ]
    number of patients requiring rescue pain medication
  • pain medication perioperatively [ Time Frame: up to 7 days postoperatively ]
    pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)
  • time to discharge [ Time Frame: up to 14 days postoperatively ]
    time to discharge from hospital
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 Evaluation of a Fast-track Knee Arthroplasty Concept
Official Title  ICMJE Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial
Brief Summary Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
Detailed Description Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Investigator and treating physicians are different in this trial, that means, the assessor of primary study endpoint will be blinded regarding group allocation. Patients receive either regional-anaesthesiological catheters preoperatively or are treatet with local infiltration technique perioperatively. For the purpose of this trial is would not be feasable to perform sham regional-anaesthesiological procedures and blinding of the treating physisican will not be possible.
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Arthropathy
  • Postoperative Pain
  • Postoperative Complications
Intervention  ICMJE
  • Procedure: local infiltration analgesia
    Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
    Other Name: LIA technique
  • Procedure: regional-anaesthesiological catheter analgesia
    Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.
Study Arms  ICMJE
  • Experimental: local infiltration analgesia
    Patient receive an infiltration of local anaesthetics around the knee to achieve maximal distal block of nerve fibres. Infiltration is performed directly after knee replacement and during weaning of general anaesthesia.
    Intervention: Procedure: local infiltration analgesia
  • Active Comparator: Regional anaesthesia
    Patients receive a combined anaesthesia with a regional-anaesthesiological catheter placed close to the distal Nervus saphenus and a single shot anaesthesia of Nervus ischiadicus using local anaesthetics (regional-anaesthesiological catheter analgesia).
    Intervention: Procedure: regional-anaesthesiological catheter analgesia
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 30, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients undergoing elective, primary knee joint replacement in combined general anaesthesia

Exclusion Criteria:

  • heart insufficiency NYHA >2
  • liver insufficiency > CHILD B
  • evidence of diabetic polyneuropathy
  • severe adipositas BMI >40
  • patients < 18 years
  • pregnancy
  • in case of police custody
  • participation in a paralleled interventional RCT in a time frame of 30 days
  • chronic opioid therapy >3 months before scheduled surgery
  • allergy against medication required for surgery or anaesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT03114306
Other Study ID Numbers  ICMJE KneeOptOut
Has Data Monitoring Committee Yes
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
Plan Description: Individual requests to analyse data are to be evaluated by local data safety authorities
Responsible Party Sascha Treskatsch, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sascha Treskatsch, Prof. Charite University Berlin, Department of anaesthesia
PRS Account Charite University, Berlin, Germany
Verification Date July 2019

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