Persona MC vs Attune Total Knee Replacement Study

NCT ID: NCT03580772

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2022-05-04

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).

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Persona TKR

Patients will have undergone a medial congruent Persona total knee replacement

Persona TKR

Intervention Type: DEVICE

Persona® TKR (Zimmer Biomet)

Attune TKR

Patients will have undergone a Attune total knee replacement

Attune TKR

Intervention Type: DEVICE

Attune® TKR (Depuy synthes)

Control participants

Patients will not have recieved a primary TKR

No interventions assigned to this group

Interventions

Persona TKR

Persona® TKR (Zimmer Biomet)

Intervention Type: DEVICE

Attune TKR

Attune® TKR (Depuy synthes)

Intervention Type: DEVICE

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

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Hemant Pandit

Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hemant Pandit, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Chapel Allerton Hospital

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS241978

Identifier Type: -

Identifier Source: org_study_id