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Completed

NCT Number: NCT03427047

Comparing Surgical and Economical Parameters of Total Knee Replacement.

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

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Key information

Conditions

Osteo Arthritis Knee Total Knee Arthroplasty

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Sports Medicine Research & Education Foundation

Indianapolis, Indiana, 46280, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MyKnee with single use Efficiency Instrument

Device

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

Stryker Navigational with conventional metal instruments

Device

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

Primary outcomes

  1. Compare Time-saving Associated With the Two Procedures.

    Time frame: Day of surgery

    Measure clean up time at end of surgery in minutes

  2. Patient OR Time From Both Study Arms

    Time frame: Day of surgery

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

Secondary outcomes

  1. Estimated Blood Loss From Both Study Arms

    Time frame: Day of surgery

    Volume of estimated blood loss in cc's

  2. Baseline of Hemoglobin Both Study Arms

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

    Measure in grams per deciliter

  3. Volume of Transfusions Both Study Arms

    Time frame: Day of surgery

    Measure amount of blood patient receives in ML

  4. Instrument Trays Sent to Sterilization Both Study Arms

    Time frame: Day of surgery

    Record number of trays sent to be sterilized

  5. Amount of Waste From Surgery Both Study Arms

    Time frame: Day of surgery

    Combined weight of recyclable and non-recyclable waste in grams

  6. Baseline of Mechanical Axis Both Study Arms

    Time frame: Baseline, post-operative 6 weeks

    Determine radiographic analysis by measuring knee mechanical axis in degrees

  7. Change From Baseline of Tibial Slope Both Study Arms

    Time frame: Baseline, post-operative 6 weeks

    Determine radiographic analysis by measuring tibial angles in degrees

  8. Related Complications

    Time frame: Baseline, day of surgery, post-op 6 weeks

    Assess adverse events and serious adverse events related to both procedures

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2018
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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