Comparing Surgical and Economical Parameters of Total Knee Replacement.

Medacta USA82 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteo Arthritis Knee Total Knee Arthroplasty

Interventions

MyKnee with single use Efficiency InstrumentDEVICE

Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation

Stryker Navigational with conventional metal instrumentsDEVICE

Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Methodist Sports Medicine Research & Education Foundation

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Compare Time-saving Associated With the Two Procedures.

Measure clean up time at end of surgery in minutes

Time frame: Day of surgery

Patient OR Time From Both Study Arms

Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes

Time frame: Day of surgery

Secondary Outcomes

Estimated Blood Loss From Both Study Arms

Volume of estimated blood loss in cc's

Time frame: Day of surgery

Baseline of Hemoglobin Both Study Arms

Measure in grams per deciliter

Time frame: Baseline, 1 day post-op or at discharge from hospital

Volume of Transfusions Both Study Arms

Measure amount of blood patient receives in ML

Time frame: Day of surgery

Instrument Trays Sent to Sterilization Both Study Arms

Record number of trays sent to be sterilized

Time frame: Day of surgery

Amount of Waste From Surgery Both Study Arms

Combined weight of recyclable and non-recyclable waste in grams

Time frame: Day of surgery

Baseline of Mechanical Axis Both Study Arms

Determine radiographic analysis by measuring knee mechanical axis in degrees

Time frame: Baseline, post-operative 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.