Persona MC vs Attune Total Knee Replacement Study

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Device: Attune TKR; Device: Persona TKR

• Registration Number: NCT03580772
• Lead Sponsor: University of Leeds

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).

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-09
• Study Start: 2018-11-26
• Primary Completion: 2019-12-04
• Status Verified: 2020-11
• Study Completion: 2022-05-04
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Attune TKR	Attune TKR	Patients will have undergone a Attune total knee replacement
Persona TKR	Persona TKR	Patients will have undergone a medial congruent Persona total knee replacement

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chapel Allerton Hospital; 🇬🇧 Leeds, United Kingdom