Knee Osteoarthritis
Conditions
Keywords
Total knee replacement, Total knee arthroplasty, Gait analysis
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).
Interventions
DEVICEPersona TKR
Persona® TKR (Zimmer Biomet)
DEVICEAttune TKR
Attune® TKR (Depuy synthes)
Sponsors
Zimmer Biomet
University of Leeds
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee extensor moment | Average 3 years ± 2 years post-surgery | Maximum knee extensor moment during stair descent of the operated limb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee adduction moment | 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 |
| Euro-QoL 5D (EQ-5D) index | Average 3 years ± 2 years post-surgery | Quality of life |
| 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 |
| 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 |
| Knee extension moments | Average 3 years ± 2 years post-surgery | During level walking, stair ascent and sit to stand |
| Ground reaction forces | Average 3 years ± 2 years post-surgery | During level walking and stair ascent/descent |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| ASA grade | Average 3 years ± 2 years post-surgery | 1/2/3 |
| Pre-operative diagnosis | Average 3 years ± 2 years post-surgery | osteoarthritis /avascular necrosis |
| Patient demographics | Average 3 years ± 2 years post-surgery | age at surgery (yrs), gender (male/female), BMI |
Countries
United Kingdom
Outcome results
None listed