Comparing Surgical and Economical Parameters of Total Knee Replacement.

Total Knee Arthroplasty Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427047
• Other study ID #: MyKnee 20170612
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2023
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Device:
• MyKnee with single use Efficiency Instrument
Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
• Stryker Navigational with conventional metal instruments
Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.

Locations

Country	Name	City	State
United States	Methodist Sports Medicine Research & Education Foundation	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

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