Arthritis of the KneeNCT02145455
Unity Total Knee Replacement Using Two Different Surgical Techniques
A study testing Unity Total Knee Replacement System in people with Arthritis of the Knee, run by Corin at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of the Knee
- What is being tested?
- Unity Total Knee Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre
Exeter, Devon, EX2 5DW
About this study
Official title: Unity Total Knee Replacement: Prospective Single-centre Clinical Study
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.
Read the 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
- Being tested
- Unity Total Knee Replacement System
- Keywords
- Arthroplasty, Replacement, Knee/methods, Knee Joint/physiopathology, Knee Joint/radiography, Knee Joint/surgery, Knee Prosthesis, Outcome Assessment (Health Care), Female, Male, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unity Total Knee Replacement SystemDevice
Also called Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised)
Unity Total Knee Replacement SystemDevice
Also called Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical alignment | Active comparator | 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. Receives: Device: Unity Total Knee Replacement System |
| Anatomic alignment | Active comparator | 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. Receives: Device: Unity Total Knee Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power of knee extension
Power of knee extension via peak torque of quads measured on a digital myometer.
Measured: 12 months post-operative
Secondary outcomes (14)
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.
Measured: 12 months post-operative
Single leg stance (SLS) test
The test measures the length of time the subject can stand on their operative leg.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
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.
Measured: 12 months post-operative
CT evaluation
CT scan will be done to assess the following anatomical items:
- Medial joint line position
- Overall limb alignment
- Joint obliquity
- Rotation
Measured: 6 weeks post-operative
Power of knee flexion
Power of knee flexion via peak torque of quads measured on a digital myometer.
Measured: 12 months post-operative
Oxford Knee Score (OKS)
A questionnaire about your ability to perform daily functions.
Measured: 12 months Post-operative
Knee Injury and Osteoarthritis Score (KOOS)
A questionnaire to assess your ability to perform activities of different difficulty levels.
Measured: 12 months Post-operative
EuroQoL 5-dimension Health State (EQ-5D)
A questionnaire to assess your health and well-being.
Measured: 12 months Post-operative
Patient Satisfaction Score
A questionnaire to assess your satisfaction with your knee implant.
Measured: 12 months Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start6 Jun 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Toms, MD, Principal investigator, Princess Elizabeth Orthopaedic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145455
- Sponsor's protocol ID
- CSP2013-08
- Status last verified
- Jul 2020
- First submitted
- 20 May 2014
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unity Total Knee Replacement: Prospective Single-centre Clinical Study
- ClinicalTrials.gov ID
- NCT02145455
- Acronym / sponsor ID
- CSP2013-08
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2015 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical alignment | Active comparator | Device: Unity Total Knee Replacement SystemPatients 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. |
| Anatomic alignment | Active comparator | Device: Unity Total Knee Replacement SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unity Total Knee Replacement SystemAlso: Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised) | Device | Mechanical alignment |
| Unity Total Knee Replacement SystemAlso: Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised) | Device | Anatomic alignment |
Primary outcome
Power of knee extension
Time frame: 12 months post-operative
Power of knee extension via peak torque of quads measured on a digital myometer.
14 secondary outcomes
Timed up and go test
Time frame: 12 months post-operative
Single leg stance (SLS) test
Time frame: 12 months post-operative
6 minute walk test
Time frame: 12 months post-operative
Timed stairs test
Time frame: 12 months post-operative
Wii Fit balance test
Time frame: 12 months post-operative
Ability to kneel
Time frame: 12 months post-operative
Sloped treadmill test
Time frame: 12 months post-operative
Walking on uneven ground
Time frame: 12 months post-operative
CT evaluation
Time frame: 6 weeks post-operative
Power of knee flexion
Time frame: 12 months post-operative
Oxford Knee Score (OKS)
Time frame: 12 months Post-operative
Knee Injury and Osteoarthritis Score (KOOS)
Time frame: 12 months Post-operative
EuroQoL 5-dimension Health State (EQ-5D)
Time frame: 12 months Post-operative
Patient Satisfaction Score
Time frame: 12 months Post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Toms, MD principal investigator
Princess Elizabeth Orthopaedic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unity Total Knee Replacement System in people with Arthritis of the Knee, run by Corin at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power of knee extension (time frame: 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.