Back to resultsUnity Total Knee Replacement Using Two Different Surgical Techniques
Primary Purpose
Arthritis of the Knee
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Unity Total Knee Replacement System
Unity Total Knee Replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis of the Knee focused on measuring Arthroplasty, Replacement, Knee/methods, Knee Joint/physiopathology, Knee Joint/radiography, Knee Joint/surgery, Knee Prosthesis, Outcome Assessment (Health Care), Female, Male, Adult
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
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
Sites / Locations
- Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mechanical alignment
Anatomic alignment
Arm 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.
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.
Outcomes
Primary Outcome Measures
Power of knee extension
Power of knee extension via peak torque of quads measured on a digital myometer.
Secondary Outcome Measures
Timed up and go test
The test measures the length of time it takes the subject to rise from a chair, walk 10 feet, turn around, and sit back down in the chair. The subject may rest or use walking aids during the test.
Single leg stance (SLS) test
The test measures the length of time the subject can stand on their operative leg.
6 minute walk test
The test measures the length of distance a subject can walk in 6 minutes at a pace that does not cause them to become short of breath. Patient may stop and rest if needed, then resume.
Timed stairs test
The test measures the length of time it takes a subject to climb up a stair block and down the other side. The subject is asked how difficult the test was on a scale of 0 to 10. The subject can use the rails, if needed.
Wii Fit balance test
The subject is asked to stand on a Wii Fit balance board while the "Deep breathing" exercise in the Yoga section is selected. The subject is instructed to follow the instructions on the screen. The subject's score is recorded and the subject is asked how difficult the test was on a scale from 1 to 10.
Ability to kneel
The subject is asked to kneel on a mat on the floor and then rise to a standing position. The subject may use a bench or the floor for balance. After the test, the subject is asked how difficult the test was on a scale of 1 to 10. The subject is allowed to refuse to do the test if he/she feels unable to do so.
Sloped treadmill test
The subject is asked to walk on a level treadmill at a comfortable walking speed. The incline of the treadmill is increased until the subject says stop or the limit of the treadmill is reached. The test is repeated with the treadmill in reverse and the subject facing backwards to simulate walking downhill. The subject is asked how difficult the test was on a scale of 1 to 10.
Walking on uneven ground
The subject is asked to walk from one end to the other on a specialized track topped with fist-sized pebbles. The subject is allowed to use walking aids. The subject is asked how difficult the test was on a scale of 1 to 10.
CT evaluation
CT scan will be done to assess the following anatomical items:
Medial joint line position
Overall limb alignment
Joint obliquity
Rotation
Power of knee flexion
Power of knee flexion via peak torque of quads measured on a digital myometer.
Oxford Knee Score (OKS)
A questionnaire about your ability to perform daily functions.
Knee Injury and Osteoarthritis Score (KOOS)
A questionnaire to assess your ability to perform activities of different difficulty levels.
EuroQoL 5-dimension Health State (EQ-5D)
A questionnaire to assess your health and well-being.
Patient Satisfaction Score
A questionnaire to assess your satisfaction with your knee implant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02145455
Brief Title
Unity Total Knee Replacement Using Two Different Surgical Techniques
Official Title
Unity Total Knee Replacement: Prospective Single-centre Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2015 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of the Knee
Keywords
Arthroplasty, Replacement, Knee/methods, Knee Joint/physiopathology, Knee Joint/radiography, Knee Joint/surgery, Knee Prosthesis, Outcome Assessment (Health Care), Female, Male, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical alignment
Arm Type
Active Comparator
Arm 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.
Arm Title
Anatomic alignment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Unity Total Knee Replacement System
Other Intervention Name(s)
Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised)
Intervention Type
Device
Intervention Name(s)
Unity Total Knee Replacement System
Other Intervention Name(s)
Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised)
Primary Outcome Measure Information:
Title
Power of knee extension
Description
Power of knee extension via peak torque of quads measured on a digital myometer.
Time Frame
12 months post-operative
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
The test measures the length of time it takes the subject to rise from a chair, walk 10 feet, turn around, and sit back down in the chair. The subject may rest or use walking aids during the test.
Time Frame
12 months post-operative
Title
Single leg stance (SLS) test
Description
The test measures the length of time the subject can stand on their operative leg.
Time Frame
12 months post-operative
Title
6 minute walk test
Description
The test measures the length of distance a subject can walk in 6 minutes at a pace that does not cause them to become short of breath. Patient may stop and rest if needed, then resume.
Time Frame
12 months post-operative
Title
Timed stairs test
Description
The test measures the length of time it takes a subject to climb up a stair block and down the other side. The subject is asked how difficult the test was on a scale of 0 to 10. The subject can use the rails, if needed.
Time Frame
12 months post-operative
Title
Wii Fit balance test
Description
The subject is asked to stand on a Wii Fit balance board while the "Deep breathing" exercise in the Yoga section is selected. The subject is instructed to follow the instructions on the screen. The subject's score is recorded and the subject is asked how difficult the test was on a scale from 1 to 10.
Time Frame
12 months post-operative
Title
Ability to kneel
Description
The subject is asked to kneel on a mat on the floor and then rise to a standing position. The subject may use a bench or the floor for balance. After the test, the subject is asked how difficult the test was on a scale of 1 to 10. The subject is allowed to refuse to do the test if he/she feels unable to do so.
Time Frame
12 months post-operative
Title
Sloped treadmill test
Description
The subject is asked to walk on a level treadmill at a comfortable walking speed. The incline of the treadmill is increased until the subject says stop or the limit of the treadmill is reached. The test is repeated with the treadmill in reverse and the subject facing backwards to simulate walking downhill. The subject is asked how difficult the test was on a scale of 1 to 10.
Time Frame
12 months post-operative
Title
Walking on uneven ground
Description
The subject is asked to walk from one end to the other on a specialized track topped with fist-sized pebbles. The subject is allowed to use walking aids. The subject is asked how difficult the test was on a scale of 1 to 10.
Time Frame
12 months post-operative
Title
CT evaluation
Description
CT scan will be done to assess the following anatomical items:
Medial joint line position
Overall limb alignment
Joint obliquity
Rotation
Time Frame
6 weeks post-operative
Title
Power of knee flexion
Description
Power of knee flexion via peak torque of quads measured on a digital myometer.
Time Frame
12 months post-operative
Title
Oxford Knee Score (OKS)
Description
A questionnaire about your ability to perform daily functions.
Time Frame
12 months Post-operative
Title
Knee Injury and Osteoarthritis Score (KOOS)
Description
A questionnaire to assess your ability to perform activities of different difficulty levels.
Time Frame
12 months Post-operative
Title
EuroQoL 5-dimension Health State (EQ-5D)
Description
A questionnaire to assess your health and well-being.
Time Frame
12 months Post-operative
Title
Patient Satisfaction Score
Description
A questionnaire to assess your satisfaction with your knee implant.
Time Frame
12 months Post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Toms, MD
Organizational Affiliation
Princess Elizabeth Orthopaedic Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
12. IPD Sharing Statement
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Unity Total Knee Replacement Using Two Different Surgical Techniques
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