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

Osteoarthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148379
• Other study ID #: 20161119
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2023
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75 years

• BMI =35

• Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)

• Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks

Exclusion Criteria:

• Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential

• Is participating in another clinical study

• Has inflammatory arthritis

• Has knee avascular necrosis

• Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis

• Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• Traditional Metal Instruments
Traditional metal instrument will be used to make bone cuts and size the components in this control group.

Locations

Country	Name	City	State
United States	Texas Orthopedics	Austin	Texas
United States	Ortho Montana	Billings	Montana
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	Orthopedic Associates Meadville	Meadville	Pennsylvania
United States	Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OR Total Time	Total time patient is in operating room	Day of Surgery
Primary	Opening Instruments	Time to open surgical instruments	Day of Surgery
Primary	Back Table Setup Time	Time to set up back surgical table	Day of Surgery
Primary	Tourniquet Time	Time tourniquet is on patient during surgery	Day of Surgery
Primary	Incision to Skin Closure	Time from incision to skin closure during surgery	Day of Surgery
Primary	Bone Prep Time	Time to prepare bone for implant during surgery	Day of Surgery
Primary	Patella Resection Time	Time to resection patella during surgery	Day of Surgery
Primary	Clean-up Time	Time to clean up following surgery	Day of Surgery
Secondary	Hemoglobin Range	Post op 1 day hemoglobin range	24 hours or at discharge if patient does not stay overnight
Secondary	Surgical Waste Weight	Weigh surgical waste at the end of each surgery	Day of Surgery
Secondary	Mechanical Axis	Radiographic analysis of mechanical axis alignment	Pre-Operative
Secondary	Mechanical Axis	Radiographic analysis of mechanical axis alignment	Post-Operative
Secondary	Tibial Slope	Radiographic analysis of Tibial Posterior Slope	Pre-Operative
Secondary	Tibial Slope	Radiographic analysis of Tibial Posterior Slope	Post-Operative