Back to resultsComparing Surgical and Economical Parameters of Total Knee Replacement.
Primary Purpose
Osteo Arthritis Knee, Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyKnee with single use Efficiency Instrument
Stryker Navigational with conventional metal instruments
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria:
- Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Sites / Locations
- Methodist Sports Medicine Research & Education Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MyKnee with single use Efficiency Instrument
Stryker Navigational with conventional metal instruments
Arm Description
Patients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee.
Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm.
Outcomes
Primary Outcome Measures
Compare Time-saving Associated With the Two Procedures.
Measure clean up time at end of surgery in minutes
Patient OR Time From Both Study Arms
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
Secondary Outcome Measures
Estimated Blood Loss From Both Study Arms
Volume of estimated blood loss in cc's
Baseline of Hemoglobin Both Study Arms
Measure in grams per deciliter
Volume of Transfusions Both Study Arms
Measure amount of blood patient receives in ML
Instrument Trays Sent to Sterilization Both Study Arms
Record number of trays sent to be sterilized
Amount of Waste From Surgery Both Study Arms
Combined weight of recyclable and non-recyclable waste in grams
Baseline of Mechanical Axis Both Study Arms
Determine radiographic analysis by measuring knee mechanical axis in degrees
Change From Baseline of Tibial Slope Both Study Arms
Determine radiographic analysis by measuring tibial angles in degrees
Related Complications
Assess adverse events and serious adverse events related to both procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03427047
Brief Title
Comparing Surgical and Economical Parameters of Total Knee Replacement.
Official Title
A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta USA
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.
No
5. Study Description
Brief Summary
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Detailed Description
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyKnee with single use Efficiency Instrument
Arm Type
Active Comparator
Arm Description
Patients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee.
Arm Title
Stryker Navigational with conventional metal instruments
Arm Type
Active Comparator
Arm Description
Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm.
Intervention Type
Device
Intervention Name(s)
MyKnee with single use Efficiency Instrument
Intervention Description
Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
Intervention Type
Device
Intervention Name(s)
Stryker Navigational with conventional metal instruments
Intervention Description
Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
Primary Outcome Measure Information:
Title
Compare Time-saving Associated With the Two Procedures.
Description
Measure clean up time at end of surgery in minutes
Time Frame
Day of surgery
Title
Patient OR Time From Both Study Arms
Description
Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Estimated Blood Loss From Both Study Arms
Description
Volume of estimated blood loss in cc's
Time Frame
Day of surgery
Title
Baseline of Hemoglobin Both Study Arms
Description
Measure in grams per deciliter
Time Frame
Baseline, 1 day post-op or at discharge from hospital
Title
Volume of Transfusions Both Study Arms
Description
Measure amount of blood patient receives in ML
Time Frame
Day of surgery
Title
Instrument Trays Sent to Sterilization Both Study Arms
Description
Record number of trays sent to be sterilized
Time Frame
Day of surgery
Title
Amount of Waste From Surgery Both Study Arms
Description
Combined weight of recyclable and non-recyclable waste in grams
Time Frame
Day of surgery
Title
Baseline of Mechanical Axis Both Study Arms
Description
Determine radiographic analysis by measuring knee mechanical axis in degrees
Time Frame
Baseline, post-operative 6 weeks
Title
Change From Baseline of Tibial Slope Both Study Arms
Description
Determine radiographic analysis by measuring tibial angles in degrees
Time Frame
Baseline, post-operative 6 weeks
Title
Related Complications
Description
Assess adverse events and serious adverse events related to both procedures
Time Frame
Baseline, day of surgery, post-op 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria:
Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hur, MD
Organizational Affiliation
Forte Sports Medicine and Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Sports Medicine Research & Education Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Surgical and Economical Parameters of Total Knee Replacement.
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