Knee OsteoarthritisPERTUNENCT03580772
Persona MC vs Attune Total Knee Replacement Study
An observational study of Knee Osteoarthritis, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Persona TKR and Attune TKR
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2018to 4 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18 years and above*
- Have undergone primary total knee replacement for either:
- Osteoarthritis
- avascular necrosis of the femur or tibia
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Persona TKR, Attune TKR
- Keywords
- Total knee replacement, Total knee arthroplasty, Gait analysis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona TKRDevice
Persona® TKR (Zimmer Biomet)
Attune TKRDevice
Attune® TKR (Depuy synthes)
| Study group | Role | What they receive |
|---|---|---|
| Persona TKR | Patients will have undergone a medial congruent Persona total knee replacement Receives: Device: Persona TKR | |
| Attune TKR | Patients will have undergone a Attune total knee replacement Receives: Device: Attune TKR | |
| Control participants | Patients will not have recieved a primary TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensor moment
Maximum knee extensor moment during stair descent of the operated limb
Measured: Average 3 years ± 2 years post-surgery
Secondary outcomes (13)
Proportion of patients able to complete each gait assessment
During level walking and stair ascent/descent
Measured: Average 3 years ± 2 years post-surgery
Gait velocity
During level walking and stair ascent/descent
Measured: Average 3 years ± 2 years post-surgery
Stance time
During level walking and stair ascent/descent
Measured: Average 3 years ± 2 years post-surgery
Knee flexion-extension range of motion
During level walking, stair ascent/descent and sit to stand
Measured: Average 3 years ± 2 years post-surgery
Knee extension moments
During level walking, stair ascent and sit to stand
Measured: Average 3 years ± 2 years post-surgery
Knee adduction moment
During level walking and stair ascent/descent
Measured: Average 3 years ± 2 years post-surgery
Ground reaction forces
During level walking and stair ascent/descent
Measured: Average 3 years ± 2 years post-surgery
Sit to stand time
During a sit to stand task
Measured: Average 3 years ± 2 years post-surgery
Knee angular velocity
During a sit to stand task
Measured: Average 3 years ± 2 years post-surgery
Total OKS
Total score, OKS function subscale and OKS pain subscale
Measured: Average 3 years ± 2 years post-surgery
2011 Knee Society Objective Knee Score
Post-operative knee function and overall health assessment
Measured: Average 3 years ± 2 years post-surgery
Euro-QoL 5D (EQ-5D) index
Quality of life
Measured: 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.
Measured: Average 3 years ± 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start26 Nov 2018
- Primary completion4 Dec 2019
- Study completion4 May 2022
Why it stopped: Due to ongoing issues with recruitment, it was decided it was best to terminate the study and focus resources on other priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Hemant Pandit, University of Leeds
- Investigators
- Hemant Pandit, MBBS, MS, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580772
- Sponsor's protocol ID
- IRAS241978
- Acronym
- PERTUNE
- Status last verified
- Nov 2020
- First submitted
- 5 Jun 2018
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03580772
- Acronym / sponsor ID
- PERTUNE / IRAS241978
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee replacement, Total knee arthroplasty, Gait analysis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to ongoing issues with recruitment, it was decided it was best to terminate the study and focus resources on other priorities.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persona TKR | – | Device: Persona TKRPatients will have undergone a medial congruent Persona total knee replacement |
| Attune TKR | – | Device: Attune TKRPatients will have undergone a Attune total knee replacement |
| Control participants | – | –Patients will not have recieved a primary TKR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persona TKRPersona® TKR (Zimmer Biomet) | Device | Persona TKR |
| Attune TKRAttune® TKR (Depuy synthes) | Device | Attune TKR |
Primary outcome
Knee extensor moment
Time frame: Average 3 years ± 2 years post-surgery
Maximum knee extensor moment during stair descent of the operated limb
13 secondary outcomes
Proportion of patients able to complete each gait assessment
Time frame: Average 3 years ± 2 years post-surgery
Gait velocity
Time frame: Average 3 years ± 2 years post-surgery
Stance time
Time frame: Average 3 years ± 2 years post-surgery
Knee flexion-extension range of motion
Time frame: Average 3 years ± 2 years post-surgery
Knee extension moments
Time frame: Average 3 years ± 2 years post-surgery
Knee adduction moment
Time frame: Average 3 years ± 2 years post-surgery
Ground reaction forces
Time frame: Average 3 years ± 2 years post-surgery
Sit to stand time
Time frame: Average 3 years ± 2 years post-surgery
Knee angular velocity
Time frame: Average 3 years ± 2 years post-surgery
Total OKS
Time frame: Average 3 years ± 2 years post-surgery
2011 Knee Society Objective Knee Score
Time frame: Average 3 years ± 2 years post-surgery
Euro-QoL 5D (EQ-5D) index
Time frame: Average 3 years ± 2 years post-surgery
Forgotten Joint Score
Time frame: Average 3 years ± 2 years post-surgery
Results and safety
The study was stopped early (reason given: Due to ongoing issues with recruitment, it was decided it was best to terminate the study and focus resources on other priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemant Pandit, MBBS, MS principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to ongoing issues with recruitment, it was decided it was best to terminate the study and focus resources on other priorities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extensor moment (time frame: Average 3 years ± 2 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.