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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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ClinicalTrials.gov Identifier: NCT03148379
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Medacta USA

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Customized patient instruments Device: Traditional Metal Instruments Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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 Name: Traditional Metal Instruments with Conventional Surgical Technique




Primary Outcome Measures :
  1. The objectives of this study are to compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: [ Time Frame: Intra-operative up to 72 hours ]
    To compare the time-saving parameters associated with the two procedures with respect to parameters such as OR preparation time, intra-operative time (OR efficiency), OR clean-up time and sterilization costs.


Secondary Outcome Measures :
  1. Demographics [ Time Frame: Pre-operative 1-90 days ]
    Pre-operative knee history

  2. Demographics [ Time Frame: Pre-operative 1-90 days ]
    Date of birth (Age)

  3. Demographics [ Time Frame: Pre-operative 1-90 days ]
    Height in inches, weight in pounds to determine BMI

  4. MRI or CT Scan [ Time Frame: Pre-operative 1-90 days ]
    Subjects in Efficiency My Knee group will have a preoperative CT or MRI to determine cutting block selection.

  5. Demographics [ Time Frame: Pre-operative 1-90 days ]
    Employment status

  6. Volume of Blood Loss [ Time Frame: Intra-operative up to 72 hours ]
    Number of pints of blood used in surgery or transfusions

  7. Number of trays sent to sterilization between the two groups [ Time Frame: Intra-operative up to 72 hours ]
    Count the number of trays sent to sterilization during surgery

  8. Post op 1 day hemoglobin [ Time Frame: 24 hours or at discharge if patient does not stay overnight ]
    Blood Draw

  9. Surgical waste weight [ Time Frame: Intra-operative up to 72 hours ]
    Weigh surgical waste at the end of each surgery (grams)

  10. Visual Analog Scale [ Time Frame: Pre-operative 1-90 days and 4-8 weeks post operative ]
    Pain score for knee

  11. Radiographic analysis [ Time Frame: pre-operative 1-90 days and 4-8 weeks post operative ]
    Radiographic analysis will include mechanical axis alignment, angle of tibial posterior slope, mechanical axis. Subjects in Efficiency My Knee group will have a preoperative CT or MRI for selection of cutting blocks.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148379


Contacts
Contact: Mukesh Ahuja, MBBS, MS 312-548-3368 Mahuja@medacta.us.com

Locations
United States, Pennsylvania
Orthopedic Associates Meadville Not yet recruiting
Meadville, Pennsylvania, United States, 16335
Contact: Ryan Molli, MD         
United States, Texas
Texas Orthopedics Recruiting
Austin, Texas, United States, 78759
Contact: Tyler Goldberg, MD    512-439-1001    tgoldberg@texasorthopedics.com   
Principal Investigator: Tyler Goldberg, MD         
United States, Utah
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence Not yet recruiting
West Jordan, Utah, United States, 84088
Contact: Charles Marshall, MD         
United States, Virginia
Tuckahoe Orthopedics Not yet recruiting
Richmond, Virginia, United States, 23226
Contact: Mathew Dobzyniak, MD         
Sponsors and Collaborators
Medacta USA
Investigators
Study Director: Mukesh Ahuja, MBBS, MS Medacta USA

Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03148379     History of Changes
Other Study ID Numbers: 20161119
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medacta USA:
Total Knee Replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases