Comparing Surgical and Economical Parameters of Total Knee Replacement.

Medacta

Status: Completed

Conditions: Total Knee Arthroplasty; Osteo Arthritis Knee

Treatments: Device: Stryker Navigational with conventional metal instruments; Device: MyKnee with single use Efficiency Instrument

Study type: Interventional

Funder types: Industry

Identifiers

NCT03427047

MyKnee 20170612

Details and patient eligibility

About

Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Full description

Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.

Enrollment: 82 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks

Exclusion criteria

• Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

MyKnee with single use Efficiency Instrument

Active Comparator group

Description:

Patients randomized in this group will undergo Total Knee Arthroplasty utilizing patient matched cutting blocks and single use instruments. Customization will be by a CT scan of patients knee.

Treatment:

Device: MyKnee with single use Efficiency Instrument

Stryker Navigational with conventional metal instruments

Active Comparator group

Description:

Patients randomized in this group will undergo Total Knee Arthroplasty with conventional metal instruments. CT scan are not utilized with this arm.

Treatment:

Device: Stryker Navigational with conventional metal instruments