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Completed

NCT Number: NCT03148379

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tandem Clinical Research, LLC, Marrero, Louisiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Customized patient instruments

Device

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®)

Traditional Metal Instruments

Device

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

Primary outcomes

  1. OR Total Time

    Time frame: Day of Surgery

    Total time patient is in operating room

  2. Opening Instruments

    Time frame: Day of Surgery

    Time to open surgical instruments

  3. Back Table Setup Time

    Time frame: Day of Surgery

    Time to set up back surgical table

  4. Tourniquet Time

    Time frame: Day of Surgery

    Time tourniquet is on patient during surgery

  5. Incision to Skin Closure

    Time frame: Day of Surgery

    Time from incision to skin closure during surgery

  6. Bone Prep Time

    Time frame: Day of Surgery

    Time to prepare bone for implant during surgery

  7. Patella Resection Time

    Time frame: Day of Surgery

    Time to resection patella during surgery

  8. Clean-up Time

    Time frame: Day of Surgery

    Time to clean up following surgery

Secondary outcomes

  1. Hemoglobin Range

    Time frame: 24 hours or at discharge if patient does not stay overnight

    Post op 1 day hemoglobin range

  2. Surgical Waste Weight

    Time frame: Day of Surgery

    Weigh surgical waste at the end of each surgery

  3. Mechanical Axis

    Time frame: Pre-Operative

    Radiographic analysis of mechanical axis alignment

  4. Mechanical Axis

    Time frame: Post-Operative

    Radiographic analysis of mechanical axis alignment

  5. Tibial Slope

    Time frame: Pre-Operative

    Radiographic analysis of Tibial Posterior Slope

  6. Tibial Slope

    Time frame: Post-Operative

    Radiographic analysis of Tibial Posterior Slope

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 11, 2017
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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