Clinical trial NCT03580772: Persona MC vs Attune Total Knee Replacement Study
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: Total knee replacement
Total knee arthroplasty
Gait analysis
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2018-07-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Knee extensor moment
timeFrame: Average 3 years ± 2 years post-surgery
Secondary outcomes:
measure: Proportion of patients able to complete each gait assessment
timeFrame: Average 3 years ± 2 years post-surgery
measure: Gait velocity
timeFrame: Average 3 years ± 2 years post-surgery
measure: Stance time
timeFrame: Average 3 years ± 2 years post-surgery
measure: Knee flexion-extension range of motion
timeFrame: Average 3 years ± 2 years post-surgery
measure: Knee extension moments
timeFrame: Average 3 years ± 2 years post-surgery
measure: Knee adduction moment
timeFrame: Average 3 years ± 2 years post-surgery
measure: Ground reaction forces
timeFrame: Average 3 years ± 2 years post-surgery
measure: Sit to stand time
timeFrame: Average 3 years ± 2 years post-surgery
measure: Knee angular velocity
timeFrame: Average 3 years ± 2 years post-surgery
measure: Total OKS
timeFrame: Average 3 years ± 2 years post-surgery
measure: 2011 Knee Society Objective Knee Score
timeFrame: Average 3 years ± 2 years post-surgery
measure: Euro-QoL 5D (EQ-5D) index
timeFrame: Average 3 years ± 2 years post-surgery
measure: Forgotten Joint Score
timeFrame: Average 3 years ± 2 years post-surgery
Other outcomes:
measure: Patient demographics
timeFrame: Average 3 years ± 2 years post-surgery
measure: Pre-operative diagnosis
timeFrame: Average 3 years ± 2 years post-surgery
measure: ASA grade
timeFrame: Average 3 years ± 2 years post-surgery
Locations:
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
Study officials:
affiliation: University of Leeds
name: Hemant Pandit, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: