Unity Total Knee Replacement Using Two Different Surgical Techniques

NCT ID: NCT02145455

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-06
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed 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.

Conditions

Arthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical alignment

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.

Group Type: ACTIVE_COMPARATOR

Unity Total Knee Replacement System

Intervention Type: DEVICE

Anatomic alignment

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.

Group Type: ACTIVE_COMPARATOR

Unity Total Knee Replacement System

Intervention Type: DEVICE

Interventions

Unity Total Knee Replacement System

Intervention Type: DEVICE

Unity Total Knee Replacement System

Intervention Type: DEVICE

Other Intervention Names

Unity Total Knee Replacement System (Cruciate Retaining); Unity Total Knee Replacement System (Posterior Stabilised); Unity Total Knee Replacement System (Cruciate Retaining); Unity Total Knee Replacement System (Posterior Stabilised)

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Toms, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Elizabeth Orthopaedic Centre

Locations

Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre

Exeter, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

CSP2013-08

Identifier Type: -

Identifier Source: org_study_id