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Due to ongoing issues with recruitment, it was decided it was best to terminate the study and focus resources on other priorities.
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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona TKR | Patients will have undergone a medial congruent Persona total knee replacement |
| |
| Attune TKR | Patients will have undergone a Attune total knee replacement |
| |
| Control participants | Patients will not have recieved a primary TKR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona TKR | Device | Persona® TKR (Zimmer Biomet) |
| |
| Attune TKR |
| Measure | Description | Time Frame |
|---|---|---|
| Knee extensor moment | Maximum knee extensor moment during stair descent of the operated limb | Average 3 years ± 2 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients able to complete each gait assessment | During level walking and stair ascent/descent | Average 3 years ± 2 years post-surgery |
| Gait velocity | During level walking and stair ascent/descent |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | age at surgery (yrs), gender (male/female), BMI | Average 3 years ± 2 years post-surgery |
| Pre-operative diagnosis | osteoarthritis /avascular necrosis |
Inclusion Criteria:
Aged 18 years and above*
Have undergone primary total knee replacement for either:
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.
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
1-5 years post TKR surgery
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:
History of infection in the replaced joint and/or other local/systemic infection that may affect the prosthetic joint
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis/any loss of musculature or neuromuscular disease that compromises the affected limb
Severe instability secondary to the absence of collateral ligament integrity
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
Patient is a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Patients who are unable to give voluntary informed consent.
Patients who are unable to walk unaided (post-surgery).
BMI > 40
** Control participants will meet the same exclusion criteria as TKR patients
Patients who suffer with cognitive impairment such as Parkinson's or Alzheimer's disease resulting in impaired mental capacity.
Patients who are unable to walk unaided.
Patients who suffer from dizzy spells or fainting episodes.
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Potential patients that have undergone either a medial congruent Persona TKR or Attune TKR will be identified by the relevant orthopaedic surgeon. Control participants will be identified from an established database.
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| Name | Affiliation | Role |
|---|---|---|
| Hemant Pandit, MBBS, MS | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chapel Allerton Hospital | Leeds | United Kingdom |
Non-identifiable data from those patients that have undergone the MC TKR surgery will be transferred to the research funder, who will combine this with data from another trial (POLAR) for analysis.
Data will be available at the end of the study and will be available for three years
Patient identifiable information will not be shared with the funder. Other relevant information will be shared after completing the study and analysing the data
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Device |
Attune® TKR (Depuy synthes) |
|
| Average 3 years ± 2 years post-surgery |
| Stance time | During level walking and stair ascent/descent | Average 3 years ± 2 years post-surgery |
| Knee flexion-extension range of motion | During level walking, stair ascent/descent and sit to stand | Average 3 years ± 2 years post-surgery |
| Knee extension moments | During level walking, stair ascent and sit to stand | Average 3 years ± 2 years post-surgery |
| Knee adduction moment | During level walking and stair ascent/descent | Average 3 years ± 2 years post-surgery |
| Ground reaction forces | During level walking and stair ascent/descent | Average 3 years ± 2 years post-surgery |
| Sit to stand time | During a sit to stand task | Average 3 years ± 2 years post-surgery |
| Knee angular velocity | During a sit to stand task | Average 3 years ± 2 years post-surgery |
| Total OKS | Total score, OKS function subscale and OKS pain subscale | Average 3 years ± 2 years post-surgery |
| 2011 Knee Society Objective Knee Score | Post-operative knee function and overall health assessment | Average 3 years ± 2 years post-surgery |
| Euro-QoL 5D (EQ-5D) index | Quality of life | Average 3 years ± 2 years post-surgery |
| 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 |
| Average 3 years ± 2 years post-surgery |
| ASA grade | 1/2/3 | Average 3 years ± 2 years post-surgery |
| D012216 |
| Rheumatic Diseases |