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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2022-03-30

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

Customized patient instruments

Intervention Type 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.

Traditional metal instruments

Control Group: Patients will undergo conventional surgical technique

Group Type ACTIVE_COMPARATOR

Traditional Metal Instruments

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Traditional Metal Instruments

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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes