NCT03427047

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Medacta USA · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteo Arthritis Knee
• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	MyKnee with single use Efficiency Instrument	Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
DEVICE	Stryker Navigational with conventional metal instruments	Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2018-02-09
• Last updated: 2023-06-13
• Results posted: 2023-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study