Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2017-05-01

Brief Summary

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To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

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Detailed Description

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This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Randomization will occur after enrolment and subjects will be blinded to assignment group. All subjects will be scheduled for and receive the same MRI experience. It is not possible to blind the surgeon to the surgical technique.

Study Groups

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Custom Block Instrumentation

Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system

Group Type ACTIVE_COMPARATOR

Visionaire

Intervention Type DEVICE

Custom cutting block using MRI to create patient specific instrumentations

Traditional Instrumentation

Traditional cutting methods for Total Knee Replacement

Group Type ACTIVE_COMPARATOR

Traditional

Intervention Type OTHER

Traditional cutting method

Interventions

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Visionaire

Custom cutting block using MRI to create patient specific instrumentations

Intervention Type DEVICE

Traditional

Traditional cutting method

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patient is male or female ages 18 and over.
2. Patient is having primary total knee replacement
3. Patient is willing to sign the informed consent and to come for all study visits.

Exclusion Criteria

1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
2. Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
3. Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
4. Patients scheduled for bilateral knee surgery (simultaneous or staged)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes