Persona MC vs Attune Total Knee Replacement Study (PERTUNE)

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: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Persona TKR; Device: Attune TKR

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: Observational
• Enrollment (Actual): 31

Contacts and Locations

• Study Contact: Name: Hemant Pandit, MBBS, MS; Phone Number: +44 113 392 4883; Email: h.pandit@leeds.ac.uk
• Study Contact Backup: Name: Graham Chapman, PhD; Phone Number: +44 113 3924920; Email: g.j.chapman@leeds.ac.uk

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Chapel Allerton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients able to complete each gait assessment	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Gait velocity	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Stance time	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Knee flexion-extension range of motion	During level walking, stair ascent/descent and sit to stand	Average 3 years ± 2 years post-surgery
Knee extension moments	During level walking, stair ascent and sit to stand	Average 3 years ± 2 years post-surgery
Knee adduction moment	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Ground reaction forces	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Sit to stand time	During a sit to stand task	Average 3 years ± 2 years post-surgery
Knee angular velocity	During a sit to stand task	Average 3 years ± 2 years post-surgery
Total OKS	Total score, OKS function subscale and OKS pain subscale	Average 3 years ± 2 years post-surgery
2011 Knee Society Objective Knee Score	Post-operative knee function and overall health assessment	Average 3 years ± 2 years post-surgery
Euro-QoL 5D (EQ-5D) index	Quality of life	Average 3 years ± 2 years post-surgery
Forgotten Joint Score	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

Outcome Measure	Measure Description	Time Frame
Patient demographics	age at surgery (yrs), gender (male/female), BMI	Average 3 years ± 2 years post-surgery
Pre-operative diagnosis	osteoarthritis /avascular necrosis	Average 3 years ± 2 years post-surgery
ASA grade	1/2/3	Average 3 years ± 2 years post-surgery

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Hemant Pandit, MBBS, MS, University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Total knee replacement; Total knee arthroplasty; Gait analysis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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