Unity Total Knee Replacement Using Two Different Surgical Techniques

July 13, 2020 updated by: Corin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Device: Unity Total Knee Replacement System
Other Names:
  • Unity Total Knee Replacement System (Cruciate Retaining)
  • Unity Total Knee Replacement System (Posterior Stabilised)
Active Comparator: 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.
Device: Unity Total Knee Replacement System
Other Names:
  • Unity Total Knee Replacement System (Cruciate Retaining)
  • Unity Total Knee Replacement System (Posterior Stabilised)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Power of knee extension
Time Frame: 12 months post-operative
Power of knee extension via peak torque of quads measured on a digital myometer.
12 months post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed up and go test
Time Frame: 12 months post-operative
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.
12 months post-operative
Single leg stance (SLS) test
Time Frame: 12 months post-operative
The test measures the length of time the subject can stand on their operative leg.
12 months post-operative
6 minute walk test
Time Frame: 12 months post-operative
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.
12 months post-operative
Timed stairs test
Time Frame: 12 months post-operative
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.
12 months post-operative
Wii Fit balance test
Time Frame: 12 months post-operative
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.
12 months post-operative
Ability to kneel
Time Frame: 12 months post-operative
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.
12 months post-operative
Sloped treadmill test
Time Frame: 12 months post-operative
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.
12 months post-operative
Walking on uneven ground
Time Frame: 12 months post-operative
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.
12 months post-operative
CT evaluation
Time Frame: 6 weeks post-operative

CT scan will be done to assess the following anatomical items:

  • Medial joint line position
  • Overall limb alignment
  • Joint obliquity
  • Rotation
6 weeks post-operative
Power of knee flexion
Time Frame: 12 months post-operative
Power of knee flexion via peak torque of quads measured on a digital myometer.
12 months post-operative
Oxford Knee Score (OKS)
Time Frame: 12 months Post-operative
A questionnaire about your ability to perform daily functions.
12 months Post-operative
Knee Injury and Osteoarthritis Score (KOOS)
Time Frame: 12 months Post-operative
A questionnaire to assess your ability to perform activities of different difficulty levels.
12 months Post-operative
EuroQoL 5-dimension Health State (EQ-5D)
Time Frame: 12 months Post-operative
A questionnaire to assess your health and well-being.
12 months Post-operative
Patient Satisfaction Score
Time Frame: 12 months Post-operative
A questionnaire to assess your satisfaction with your knee implant.
12 months Post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Toms, MD, Princess Elizabeth Orthopaedic Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSP2013-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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