NCT03148379

Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medacta USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Customized patient instruments	Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
DEVICE	Traditional Metal Instruments	Traditional metal instrument will be used to make bone cuts and size the components in this control group.

Timeline

• Start date: 2017-10-11
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2017-05-11
• Last updated: 2023-08-08
• Results posted: 2023-08-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study