NCT03580772

Persona MC vs Attune Total Knee Replacement Study

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Persona TKR	Persona® TKR (Zimmer Biomet)
DEVICE	Attune TKR	Attune® TKR (Depuy synthes)

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-12-04
• Completion: 2022-05-04
• First posted: 2018-07-09
• Last updated: 2023-09-11

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study