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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

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Procedure: Unicompartmental knee arthroplasty Procedure: Total knee arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: UKA
Medial unicompartmental knee arthroplasty
Procedure: Unicompartmental knee arthroplasty
Implant to replace the medial compartment of a patient with knee osteoarthritis

Active Comparator: TKA
Total knee arthroplasty
Procedure: Total knee arthroplasty
Implant to replace the knee joint of a patient with knee osteoarthritis




Primary Outcome Measures :
  1. Knee Society Score [ Time Frame: 1 year ]
    Functional outcome questionnaire ranging from 0-100, with 100 being best

  2. Knee Society Score [ Time Frame: 2 years ]
    Functional knee outcome questionnaire ranging from 0-100, with 100 being best


Secondary Outcome Measures :
  1. Revision [ Time Frame: 2 years ]
    complication requiring revision surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03385759


Contacts
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Contact: Nancy Parks, MS 703-619-4423 nparks@aori.org
Contact: Chris Culvern, MS 312-432-2470 chris.culvern@rushortho.com

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Chris Culvern, MS    312-432-2470    chris.culvern@rushortho.com   
Principal Investigator: Craig Della Valle, MD         
United States, Virginia
Anderson Orthopaedic Research Institute Recruiting
Alexandria, Virginia, United States, 22306
Contact: Nancy L Parks, MS    703-619-4423    nparks@aori.org   
Principal Investigator: Kevin B Fricka, MD         
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
Rush University Medical Center
Investigators
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Principal Investigator: Kevin Fricka, MD Anderson Orthopaedic Institute

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Responsible Party: Nancy Parks, Sr. Project Director, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT03385759     History of Changes
Other Study ID Numbers: 17-2931
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
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: 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

Keywords provided by Nancy Parks, Anderson Orthopaedic Research Institute:
unicompartmental knee
total knee arthroplasty
osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases