NCT02145455

Unity Total Knee Replacement Using Two Different Surgical Techniques

Unity Total Knee Replacement: Prospective Single-centre Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Unity Total Knee Replacement System
DEVICE	Unity Total Knee Replacement System

Timeline

• Start date: 2015-06-06
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2014-05-23
• Last updated: 2020-07-14

Locations

1 site across 1 country: United Kingdom