Persona MC vs Attune Total Knee Replacement Study (PERTUNE)

September 6, 2023 updated by: Hemant Pandit, University of Leeds

Functional Comparison of Two Modern Designs of Total Knee Replacement - a Post-operative Comparator Gait Study Comparing Persona MC to Attune Total Knee Replacement

This study aims to compare clinical and functional outcomes of a cohort of patients that have undergone a medial congruent TKR to a similar cohort of patients that have undergone a conventional TKR and a cohort of control participants. Our null hypothesis is that there will be no difference in the functional outcome (as assessed by gait analysis) between Attune and Persona MC TKR.

Study Overview

Status

Status

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

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 cross sectional, post-operative comparator gait study aims to compare the functional and patient reported outcomes of patients that have undergone a MC TKR to an age, gender, BMI, pre-operative diagnosis with satisfactory clinical outcome at one year (OKS > 34) matched cohort of patients undergone a modern generation TKR which utilises a gradually reducing radius of curvature on the femoral component with conventional polyethylene (Attune) to a TKR with gradually reducing radius of curvature on the femoral component but a medial congruent (MC) TKR design (Persona).

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.
Observational

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.
31

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Potential patients that have undergone either a medial congruent Persona TKR or Attune TKR will be identified by the relevant orthopaedic surgeon. Control participants will be identified from an established database.

Description

Inclusion Criteria:

  1. Aged 18 years and above*

  2. Have undergone primary total knee replacement for either:

    1. Osteoarthritis
    2. avascular necrosis of the femur or tibia
  3. Report an Oxford Knee Score greater than 34, obtained from usual clinical practice. OKS above 34 represents (range 0-48, high representing good outcome) a good outcome post-surgery.
  4. Independent of study participation, patients received either commercially available Zimmer Biomet Persona MC bearing or DePuy Synthes Attune knee implants implanted in accordance with product labelling
  5. 1-5 years post TKR surgery
  6. An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires* * Control participants will meet same inclusion criteria except no primary TKR and OKS will not be required

Exclusion Criteria:

  1. History of infection in the replaced joint and/or other local/systemic infection that may affect the prosthetic joint
  2. Skeletal immaturity
  3. Neuropathic arthropathy
  4. Osteoporosis/any loss of musculature or neuromuscular disease that compromises the affected limb
  5. Severe instability secondary to the absence of collateral ligament integrity
  6. Pregnancy - routine clinical practice ensures that all female patients are asked whether they are pregnant and can safely receive x-rays or surgery as per standard consent forms
  7. Patient is a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
  8. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
  9. Patients who are unable to give voluntary informed consent.
  10. Patients who are unable to walk unaided (post-surgery).

  11. BMI > 40

    ** Control participants will meet the same exclusion criteria as TKR patients

  12. Patients who suffer with cognitive impairment such as Parkinson's or Alzheimer's disease resulting in impaired mental capacity.
  13. Patients who are unable to walk unaided.
  14. Patients who suffer from dizzy spells or fainting episodes.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Persona TKR
Patients will have undergone a medial congruent Persona total knee replacement
Device: Persona TKR
Persona® TKR (Zimmer Biomet)
Attune TKR
Patients will have undergone a Attune total knee replacement
Device: Attune TKR
Attune® TKR (Depuy synthes)
Control participants
Patients will not have recieved a primary TKR

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
Knee extensor moment
Time Frame: Average 3 years ± 2 years post-surgery
Maximum knee extensor moment during stair descent of the operated limb
Average 3 years ± 2 years post-surgery

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
Proportion of patients able to complete each gait assessment
Time Frame: Average 3 years ± 2 years post-surgery
During level walking and stair ascent/descent
Average 3 years ± 2 years post-surgery
Gait velocity
Time Frame: Average 3 years ± 2 years post-surgery
During level walking and stair ascent/descent
Average 3 years ± 2 years post-surgery
Stance time
Time Frame: Average 3 years ± 2 years post-surgery
During level walking and stair ascent/descent
Average 3 years ± 2 years post-surgery
Knee flexion-extension range of motion
Time Frame: Average 3 years ± 2 years post-surgery
During level walking, stair ascent/descent and sit to stand
Average 3 years ± 2 years post-surgery
Knee extension moments
Time Frame: Average 3 years ± 2 years post-surgery
During level walking, stair ascent and sit to stand
Average 3 years ± 2 years post-surgery
Knee adduction moment
Time Frame: Average 3 years ± 2 years post-surgery
During level walking and stair ascent/descent
Average 3 years ± 2 years post-surgery
Ground reaction forces
Time Frame: Average 3 years ± 2 years post-surgery
During level walking and stair ascent/descent
Average 3 years ± 2 years post-surgery
Sit to stand time
Time Frame: Average 3 years ± 2 years post-surgery
During a sit to stand task
Average 3 years ± 2 years post-surgery
Knee angular velocity
Time Frame: Average 3 years ± 2 years post-surgery
During a sit to stand task
Average 3 years ± 2 years post-surgery
Total OKS
Time Frame: Average 3 years ± 2 years post-surgery
Total score, OKS function subscale and OKS pain subscale
Average 3 years ± 2 years post-surgery
2011 Knee Society Objective Knee Score
Time Frame: Average 3 years ± 2 years post-surgery
Post-operative knee function and overall health assessment
Average 3 years ± 2 years post-surgery
Euro-QoL 5D (EQ-5D) index
Time Frame: Average 3 years ± 2 years post-surgery
Quality of life
Average 3 years ± 2 years post-surgery
Forgotten Joint Score
Time Frame: Average 3 years ± 2 years post-surgery
The Forgotten Joint Score is a 12-item questionnaire completed by the patient to determine how aware they are of their joint in their everyday life.
Average 3 years ± 2 years post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient demographics
Time Frame: Average 3 years ± 2 years post-surgery
age at surgery (yrs), gender (male/female), BMI
Average 3 years ± 2 years post-surgery
Pre-operative diagnosis
Time Frame: Average 3 years ± 2 years post-surgery
osteoarthritis /avascular necrosis
Average 3 years ± 2 years post-surgery
ASA grade
Time Frame: Average 3 years ± 2 years post-surgery
1/2/3
Average 3 years ± 2 years post-surgery

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.
University of Leeds

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zimmer Biomet

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: Hemant Pandit, MBBS, MS, University of Leeds

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.
November 26, 2018

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.
December 4, 2019

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 4, 2022

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).
June 5, 2018

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.
June 25, 2018

First Posted (Actual)

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.
July 9, 2018

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.
September 11, 2023

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.
September 6, 2023

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.
November 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.
  • IRAS241978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identifiable data from those patients that have undergone the MC TKR surgery will be transferred to the research funder, who will combine this with data from another trial (POLAR) for analysis.

IPD Sharing Time Frame

Data will be available at the end of the study and will be available for three years

IPD Sharing Access Criteria

Patient identifiable information will not be shared with the funder. Other relevant information will be shared after completing the study and analysing the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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