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.

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Customized patient instruments; Device: Traditional Metal Instruments

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research, LLC
  • Montana
    • Billings, Montana, United States, 59101
      • Ortho Montana
  • Pennsylvania
    • Meadville, Pennsylvania, United States, 16335
      • Orthopedic Associates Meadville
  • Texas
    • Austin, Texas, United States, 78759
      • Texas Orthopedics
  • Utah
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Customized patient instruments; Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)	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.; Other Names: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)
Active Comparator: Traditional metal instruments; Control Group: Patients will undergo conventional surgical technique	Device: Traditional Metal Instruments; Traditional metal instrument will be used to make bone cuts and size the components in this control group.; Other Names: Traditional Metal Instruments with Conventional Surgical Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR Total Time	Total time patient is in operating room	Day of Surgery
Opening Instruments	Time to open surgical instruments	Day of Surgery
Back Table Setup Time	Time to set up back surgical table	Day of Surgery
Tourniquet Time	Time tourniquet is on patient during surgery	Day of Surgery
Incision to Skin Closure	Time from incision to skin closure during surgery	Day of Surgery
Bone Prep Time	Time to prepare bone for implant during surgery	Day of Surgery
Patella Resection Time	Time to resection patella during surgery	Day of Surgery
Clean-up Time	Time to clean up following surgery	Day of Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Range	Post op 1 day hemoglobin range	24 hours or at discharge if patient does not stay overnight
Surgical Waste Weight	Weigh surgical waste at the end of each surgery	Day of Surgery
Mechanical Axis	Radiographic analysis of mechanical axis alignment	Pre-Operative
Mechanical Axis	Radiographic analysis of mechanical axis alignment	Post-Operative
Tibial Slope	Radiographic analysis of Tibial Posterior Slope	Pre-Operative
Tibial Slope	Radiographic analysis of Tibial Posterior Slope	Post-Operative

Collaborators and Investigators

• Sponsor: Medacta USA
• Investigators: Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Total Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 20161119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No