Back to resultsTrial of Unicompartmental Versus Total Knee Arthroplasty
Primary Purpose
Osteo Arthritis Knee
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unicompartmental knee arthroplasty
Total knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring unicompartmental knee, total knee arthroplasty, osteoarthritis
Eligibility 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
Sites / Locations
- Rush University Medical Center
- Anderson Orthopaedic Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
UKA
TKA
Arm Description
Medial unicompartmental knee arthroplasty
Total knee arthroplasty
Outcomes
Primary Outcome Measures
Knee Society Score
Functional outcome questionnaire ranging from 0-100, with 100 being best
Knee Society Score
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
Secondary Outcome Measures
Revision
complication requiring revision surgery
Full Information
NCT ID
NCT03385759
First Posted
December 21, 2017
Last Updated
November 9, 2022
Sponsor
Anderson Orthopaedic Research Institute
Collaborators
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03385759
Brief Title
Trial of Unicompartmental Versus Total Knee Arthroplasty
Official Title
A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anderson Orthopaedic Research Institute
Collaborators
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
unicompartmental knee, total knee arthroplasty, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UKA
Arm Type
Active Comparator
Arm Description
Medial unicompartmental knee arthroplasty
Arm Title
TKA
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Unicompartmental knee arthroplasty
Intervention Description
Implant to replace the medial compartment of a patient with knee osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Implant to replace the knee joint of a patient with knee osteoarthritis
Primary Outcome Measure Information:
Title
Knee Society Score
Description
Functional outcome questionnaire ranging from 0-100, with 100 being best
Time Frame
1 year
Title
Knee Society Score
Description
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Revision
Description
complication requiring revision surgery
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Fricka, MD
Organizational Affiliation
Anderson Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Anderson Orthopaedic Research Institute
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial of Unicompartmental Versus Total Knee Arthroplasty
We'll reach out to this number within 24 hrs