Comparing Surgical and Economical Parameters of Total Knee Replacement.

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty; Osteo Arthritis Knee

• Registration Number: NCT03427047
• Lead Sponsor: Medacta USA

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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Study Start: 2018-08-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Results First Submitted: 2023-03-17
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Results First Posted: 2023-06-13
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Sports Medicine Research & Education Foundation; 🇺🇸 Indianapolis, Indiana, United States