Comparing Surgical and Economical Parameters of Total Knee Replacement.

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.

Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee; Total Knee Arthroplasty
• Intervention / Treatment: Device: MyKnee with single use Efficiency Instrument; Device: Stryker Navigational with conventional metal instruments

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46280
      • Methodist Sports Medicine Research & Education Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MyKnee with single use Efficiency Instrument; 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.	Device: MyKnee with single use Efficiency Instrument; Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
Active Comparator: Stryker Navigational with conventional metal instruments; Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm.	Device: Stryker Navigational with conventional metal instruments; Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Time-saving Associated With the Two Procedures.	Measure clean up time at end of surgery in minutes	Day of surgery
Patient OR Time From Both Study Arms	Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss From Both Study Arms	Volume of estimated blood loss in cc's	Day of surgery
Baseline of Hemoglobin Both Study Arms	Measure in grams per deciliter	Baseline, 1 day post-op or at discharge from hospital
Volume of Transfusions Both Study Arms	Measure amount of blood patient receives in ML	Day of surgery
Instrument Trays Sent to Sterilization Both Study Arms	Record number of trays sent to be sterilized	Day of surgery
Amount of Waste From Surgery Both Study Arms	Combined weight of recyclable and non-recyclable waste in grams	Day of surgery
Baseline of Mechanical Axis Both Study Arms	Determine radiographic analysis by measuring knee mechanical axis in degrees	Baseline, post-operative 6 weeks
Change From Baseline of Tibial Slope Both Study Arms	Determine radiographic analysis by measuring tibial angles in degrees	Baseline, post-operative 6 weeks
Related Complications	Assess adverse events and serious adverse events related to both procedures	Baseline, day of surgery, post-op 6 weeks

Collaborators and Investigators

• Sponsor: Medacta USA
• Investigators: Principal Investigator: John Hur, MD, Forte Sports Medicine and Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MyKnee 20170612

Drug and device information, study documents

• 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