Unity Total Knee Replacement Using Two Different Surgical Techniques

Corin

Status: Completed

Conditions: Arthritis of the Knee

Treatments: Device: Unity Total Knee Replacement System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145455

CSP2013-08

Details and patient eligibility

About

This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients' ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.

Full description

This study will be conducted at a single centre. The study has two treatment groups. One group of 50 knees (approximately 50 subjects) will have a surgical method that uses mechanical alignment (alignment based on how the leg and knee joint move) to determine the proper position of the knee replacement device. The other group of 50 knees (approximately 50 subjects) will have a surgical method that uses anatomical alignment (alignment based on how the anatomy/structure of the leg and knee joint) determine the proper position of the knee replacement device. Subjects will be randomly assigned to one of the two groups. Clinical and functional tests will be conducted pre-operatively and at 6 weeks, 3 months, 6 months and 12 months to determine overall knee function. In addition, a CT scan will be completed pre-operatively and at 6 weeks to assess changes in alignment.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must be listed for a primary total knee replacement using the Corin Unity Total Knee Replacement System, according to the product 'Instructions For Use'
• The patient must give signed informed consent to participate in the study
• The patient must be able to understand all that is expected of them and be able to comply with the study protocol
• Male and female patients who are skeletally mature

Exclusion criteria

• Any patient with a total knee replacement not implanted with a Corin Unity Total Knee Replacement
• Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee
• Any patient with fixed flexion contracture greater than 20 degrees
• Any patient with varus/valgus deformity greater than 15 degrees
• Any case not described in the inclusion criteria
• Any patient who cannot or will not provide signed informed consent for participation in the study
• Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
• Any patient with a known sensitivity to device material
• Any patient who is pregnant
• Any patient currently a prisoner
• Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
• Any patient currently involved in any personal injury litigation, medical-legal or worker's compensations claims
• Any patient unable to read and understand English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Mechanical alignment

Active Comparator group

Description:

Patients in this arm will have the Unity Total Knee Replacement System implanted using a surgical technique that utilizes mechanical alignment via measured resection to establish knee alignment.

Treatment:

Device: Unity Total Knee Replacement System

Device: Unity Total Knee Replacement System

Anatomic alignment

Active Comparator group

Description:

Patients in this arm will have the Unity Total Knee Replacement System implanted using a surgical technique that utilizes anatomic alignment via ligament balancing with the tibial cut perpendicular to the tibial anatomic axis.

Treatment:

Device: Unity Total Knee Replacement System

Device: Unity Total Knee Replacement System