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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized patient instruments
Traditional Metal Instruments
Sponsored by
Medacta USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tandem Clinical Research, LLC
  • Ortho Montana
  • Orthopedic Associates Meadville
  • Texas Orthopedics
  • Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Customized patient instruments

Traditional metal instruments

Arm Description

Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)

Control Group: Patients will undergo conventional surgical technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin Range
Post op 1 day hemoglobin range
Surgical Waste Weight
Weigh surgical waste at the end of each surgery
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Mechanical Axis
Radiographic analysis of mechanical axis alignment
Tibial Slope
Radiographic analysis of Tibial Posterior Slope
Tibial Slope
Radiographic analysis of Tibial Posterior Slope

Full Information

First Posted
April 20, 2017
Last Updated
August 4, 2023
Sponsor
Medacta USA
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1. Study Identification

Unique Protocol Identification Number
NCT03148379
Brief Title
Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Customized patient instruments
Arm Type
Experimental
Arm Description
Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Arm Title
Traditional metal instruments
Arm Type
Active Comparator
Arm Description
Control Group: Patients will undergo conventional surgical technique
Intervention Type
Device
Intervention Name(s)
Customized patient instruments
Other Intervention Name(s)
Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Metal Instruments
Other Intervention Name(s)
Traditional Metal Instruments with Conventional Surgical Technique
Intervention Description
Traditional metal instrument will be used to make bone cuts and size the components in this control group.
Primary Outcome Measure Information:
Title
OR Total Time
Description
Total time patient is in operating room
Time Frame
Day of Surgery
Title
Opening Instruments
Description
Time to open surgical instruments
Time Frame
Day of Surgery
Title
Back Table Setup Time
Description
Time to set up back surgical table
Time Frame
Day of Surgery
Title
Tourniquet Time
Description
Time tourniquet is on patient during surgery
Time Frame
Day of Surgery
Title
Incision to Skin Closure
Description
Time from incision to skin closure during surgery
Time Frame
Day of Surgery
Title
Bone Prep Time
Description
Time to prepare bone for implant during surgery
Time Frame
Day of Surgery
Title
Patella Resection Time
Description
Time to resection patella during surgery
Time Frame
Day of Surgery
Title
Clean-up Time
Description
Time to clean up following surgery
Time Frame
Day of Surgery
Secondary Outcome Measure Information:
Title
Hemoglobin Range
Description
Post op 1 day hemoglobin range
Time Frame
24 hours or at discharge if patient does not stay overnight
Title
Surgical Waste Weight
Description
Weigh surgical waste at the end of each surgery
Time Frame
Day of Surgery
Title
Mechanical Axis
Description
Radiographic analysis of mechanical axis alignment
Time Frame
Pre-Operative
Title
Mechanical Axis
Description
Radiographic analysis of mechanical axis alignment
Time Frame
Post-Operative
Title
Tibial Slope
Description
Radiographic analysis of Tibial Posterior Slope
Time Frame
Pre-Operative
Title
Tibial Slope
Description
Radiographic analysis of Tibial Posterior Slope
Time Frame
Post-Operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukesh Ahuja, MBBS, MS
Organizational Affiliation
Medacta USA
Official's Role
Study Director
Facility Information:
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Ortho Montana
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Orthopedic Associates Meadville
City
Meadville
State/Province
Pennsylvania
ZIP/Postal Code
16335
Country
United States
Facility Name
Texas Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

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

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