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Clinical Trials/EUCTR2013-001008-13-NL
EUCTR2013-001008-13-NL
Active, not recruiting
Not Applicable

Fast-track rehabilitation protocol for Total Knee Arthroplasty: A Randomized Controlled Trial comparing Local Infiltration Analgesia with Femoral Nerve Block - Fast track TKA: LIA vs FNB

Sint Maartenskliniek0 sitesJune 25, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
patients requiring total knee arthroplasty for non-inflammatory osteoarthritis of the knee
Sponsor
Sint Maartenskliniek
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 25, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 50\-80 years
  • ASA physical health classification I – II
  • patient presents with non\-inflammatory primary knee osteoarthritis (radiological confirmation)
  • patient planned for a primary unilateral posterior\-stabilized tri\-compartmental cemented total knee replacement (Genesis II \- PS)
  • scheduled for fast\-track protocol TKA
  • patient plans to be available for follow\-up through one year postoperative
  • written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • any contra\-indication for regional anesthesia
  • any contra\-indication for spinal anesthesia
  • traumatic osteoarthritis requiring TKA
  • an active, local infection or systemic infection
  • known hypersensitivity to amide\-type local anesthetics
  • known hypersensitivity to opioids
  • a Body Mass Index (BMI) \> 40 kg/m2
  • inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
  • scheduled for contralateral TKA within 1 year post\-operative
  • scheduled for another operation within 3 months post\-operative

Outcomes

Primary Outcomes

Not specified

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