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Trial of Unicompartmental Versus Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03385759
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Rush University Medical Center
Information provided by (Responsible Party):
Nancy Parks, Anderson Orthopaedic Research Institute

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE May 22, 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Knee Society Score [ Time Frame: 1 year ]
    Functional outcome questionnaire ranging from 0-100, with 100 being best
  • Knee Society Score [ Time Frame: 2 years ]
    Functional knee outcome questionnaire ranging from 0-100, with 100 being best
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • Knee Score [ Time Frame: 1 year ]
    Functional outcome questionnaire
  • Knee Score [ Time Frame: 2 years ]
    Functional knee outcome questionnaire
Change History Complete list of historical versions of study NCT03385759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
Revision [ Time Frame: 2 years ]
complication requiring revision surgery
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 Trial of Unicompartmental Versus Total Knee Arthroplasty
Official Title  ICMJE A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
Brief Summary This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.
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 Osteo Arthritis Knee
Intervention  ICMJE
  • Procedure: Unicompartmental knee arthroplasty
    Implant to replace the medial compartment of a patient with knee osteoarthritis
  • Procedure: Total knee arthroplasty
    Implant to replace the knee joint of a patient with knee osteoarthritis
Study Arms  ICMJE
  • Active Comparator: UKA
    Medial unicompartmental knee arthroplasty
    Intervention: Procedure: Unicompartmental knee arthroplasty
  • Active Comparator: TKA
    Total knee arthroplasty
    Intervention: Procedure: Total knee arthroplasty
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2017)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • medial compartment osteoarthritis of the knee
  • knee flexion greater than greater than 90 degrees
  • flexion contracture of less than 10 degrees
  • varus deformity < 20 degrees
  • grade IV degeneration of the medial compartment

Exclusion Criteria:

  • lateral compartment degenerative changes
  • previous lateral meniscectomy
  • anterior cruciate ligament deficiency
  • body mass index > 40
  • inflammatory arthritis
  • history of septic arthritis
  • hemoglobin A1c > 8.0
  • chronic liver disease
  • stage 3A or greater chronic renal disease
  • active IV drug abuse
  • patients requiring thromboembolic prophylaxis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nancy Parks, MS 703-619-4423 nparks@aori.org
Contact: Chris Culvern, MS 312-432-2470 chris.culvern@rushortho.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03385759
Other Study ID Numbers  ICMJE 17-2931
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nancy Parks, Anderson Orthopaedic Research Institute
Study Sponsor  ICMJE Anderson Orthopaedic Research Institute
Collaborators  ICMJE Rush University Medical Center
Investigators  ICMJE
Principal Investigator: Kevin Fricka, MD Anderson Orthopaedic Institute
PRS Account Anderson Orthopaedic Research Institute
Verification Date July 2018

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