Persona MC vs Attune Total Knee Replacement Study

Knee Osteoarthritis Clinical Trial

— PERTUNE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03580772
• Other study ID #: IRAS241978
• Status: Terminated
• Start date: November 26, 2018
• Est. completion date: May 4, 2022

Study information

• Verified date: November 2020
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 4, 2022
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Persona TKR
Persona® TKR (Zimmer Biomet)
• Attune TKR
Attune® TKR (Depuy synthes)

Locations

Country	Name	City	State
United Kingdom	Chapel Allerton Hospital	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Zimmer Biomet

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient demographics	age at surgery (yrs), gender (male/female), BMI	Average 3 years ± 2 years post-surgery
Other	Pre-operative diagnosis	osteoarthritis /avascular necrosis	Average 3 years ± 2 years post-surgery
Other	ASA grade	1/2/3	Average 3 years ± 2 years post-surgery
Primary	Knee extensor moment	Maximum knee extensor moment during stair descent of the operated limb	Average 3 years ± 2 years post-surgery
Secondary	Proportion of patients able to complete each gait assessment	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Secondary	Gait velocity	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Secondary	Stance time	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Secondary	Knee flexion-extension range of motion	During level walking, stair ascent/descent and sit to stand	Average 3 years ± 2 years post-surgery
Secondary	Knee extension moments	During level walking, stair ascent and sit to stand	Average 3 years ± 2 years post-surgery
Secondary	Knee adduction moment	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Secondary	Ground reaction forces	During level walking and stair ascent/descent	Average 3 years ± 2 years post-surgery
Secondary	Sit to stand time	During a sit to stand task	Average 3 years ± 2 years post-surgery
Secondary	Knee angular velocity	During a sit to stand task	Average 3 years ± 2 years post-surgery
Secondary	Total OKS	Total score, OKS function subscale and OKS pain subscale	Average 3 years ± 2 years post-surgery
Secondary	2011 Knee Society Objective Knee Score	Post-operative knee function and overall health assessment	Average 3 years ± 2 years post-surgery
Secondary	Euro-QoL 5D (EQ-5D) index	Quality of life	Average 3 years ± 2 years post-surgery
Secondary	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