Persona MC vs Attune Total Knee Replacement Study

Study Overview
=================
Brief Summary
-----------------
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.

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).

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Persona TKR
* Device: Attune TKR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and above* Have undergone primary total knee replacement for either: Osteoarthritis avascular necrosis of the femur or tibia 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. 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 1-5 years post TKR surgery 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: History of infection in the replaced joint and/or other local/systemic infection that may affect the prosthetic joint Skeletal immaturity Neuropathic arthropathy Osteoporosis/any loss of musculature or neuromuscular disease that compromises the affected limb Severe instability secondary to the absence of collateral ligament integrity 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 Patient is a member of a protected population (e.g., prisoner, mentally incompetent, etc.) Patient has previously received partial or total knee arthroplasty for the ipsilateral knee Patients who are unable to give voluntary informed consent. Patients who are unable to walk unaided (post-surgery). BMI > 40 ** Control participants will meet the same exclusion criteria as TKR patients Patients who suffer with cognitive impairment such as Parkinson's or Alzheimer's disease resulting in impaired mental capacity. Patients who are unable to walk unaided. Patients who suffer from dizzy spells or fainting episodes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persona TKR<br>Patients will have undergone a medial congruent Persona total knee replacement | Device: Persona TKR<br>* Persona® TKR (Zimmer Biomet)<br>|
| Attune TKR<br>Patients will have undergone a Attune total knee replacement | Device: Attune TKR<br>* Attune® TKR (Depuy synthes)<br>|
| Control participants<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee replacement, Total knee arthroplasty, Gait analysis