Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483178
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-31
Brief Title:
Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties
Sponsor:
Belfast Health and Social Care Trust
Organization:
Belfast Health and Social Care Trust
Study Overview
Official Title:
A Randomised Controlled Trial Comparing Gait in Fixed or Rotating Cementless Total Knee Arthroplasties
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G-FORCE
Brief Summary:
The number of patients requiring knee replacements is increasing every year due to the combination of an aging population increased patient expectancy and rising levels of obesity Therefore newer implants or design features are introduced on a regular basis to try to improve patient outcomes In 2013 DePuy Synthes launched the Attune Knee System to provide improved range of motion and address the unstable feeling some patients experience whilst performing everyday activities such as going down stairs The Attune cementless rotating platform knee was first implanted in September 2016 In 2004 the first Triathlon total knee designed by Stryker was implanted Registry figures for both the Attune and Triathlon knees are promising with good implant longevity and outcomes
There is only a small amount of literature available on the Attune knee as it is still a relatively new implant Worldwide the Triathlon is widely used and is also a well-established successful implant used in the investigators unit This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant
There is only a small amount of literature available on the Attune knee as it is still a relatively new implant Worldwide the Triathlon is widely used and is also a well-established successful implant used in the investigators unit This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant
Detailed Description:
The number of patients requiring Total Knee Arthroplasty TKA is increasing every year due to the combination of an aging population increased patient expectancy and rising levels of obesity which accelerates the onset of osteoarthritis Therefore newer implants or design features are introduced on a regular basis in an attempt to incrementally improve patient outcomes In 2013 DePuy Synthes launched the Attune Knee System to provide improved range of motion ROM and address the unstable feeling some patients experience whilst performing everyday activities such as descending stairs The Attune Knee System features a gradually reducing femoral radius an innovative s-curve design of the posteriorly stabilised cam a tibial base which can be downsized or upsized two sizes versus the insert novel patella tracking lighter innovative instruments and a new polyethylene formulation These implant properties could potentially produce improved gait and speed better stability of the knee in deep flexion reduced joint forces better patella tracking improved operative flexibility and efficiency and implant longevity The system currently comprises 14 femoral sizes 10 tibial sizes and 5 patella options
Registry figures regarding the Attune Knee System are promising The 2020 figures from the National Joint Registry NJR for England Wales Northern Ireland and the Isle of Man show that the cumulative revision rate for the Attune knee fixed bearing was 27 95 confidence interval CI 232-317 at 5 years ie implant survivorship at 5 years of 973 out of 25723 knee joints The cumulative revision rate for the Attune knee rotating platform RP was 17 95 CI 117-250 at 5 years ie implant survivorship at 5 years of 983 out of 4254 knee joints Figures from the Australian Orthopaedic Association National Joint Replacement Registry AOANJRR 2020 Report show that the 5-year cumulative revision rate of the Attune Cruciate Retaining implant was 30 95 CI 27 to 35 out of 15300 knees The 5-year cumulative revision rate of the Attune Posterior Stabilized PS implant was 26 95 CI 21 to 33 out of 7179 knees
The Attune cementless Rotating Platform was first implanted in September 2016 and by February of 2021 over 22000 have been implanted worldwide There are only a small number of studies regarding the Attune implant due to its infancy In 2004 the first Triathlon total knee Stryker was implanted The Triathlon knee was designed to address the main reasons for revision surgery such as instability patellofemoral tracking complications and looseningosteolysis There are cruciate-retaining condylar-stabilising posterior-stabilising and difficult primary options available The single radius design allows for mid-flexion stability Over 3 million Triathlon knees have been implanted worldwide
Joint registries show a high rate of survivorship of the Triathlon with over 10 years of follow up The 2020 figures from the NJR for England Wales Northern Ireland and the Isle of Man show that the cumulative revision rate for the Triathlon was 22 95 CI 210-220 at 5 years ie implant survivorship at 5 years of 978 and 34 95 CI 318-356 at 10 years ie implant survivorship at 10 years of 966 out of 133729 knee joints Figures from the AOANJRR 2020 Report show that the cumulative revision rate of the Triathlon CR implant was 25 95 CI 24 to 27 at 5 years and 39 95 CI 37 to 42 at 10 years out of a total 50402 knees The cumulative revision rate of the Triathlon PS implant was 40 95 CI 36 to 45 at 5 years and 61 95 CI 55 to 69 at 10 years out of a total 8755 knees
To the investigators knowledge the only study to compare the Attune and Triathlon TKAs was a retrospective cohort analysis in 2018 using cemented components The Attune implant was received by 1178 patients whilst the Triathlon implant was received by 5707 patients Patients who received the Attune TKA had a statistically significantly shorter length of stay and operating room time were statistically significantly less likely to be discharged to a skilled nursing facility or other inpatient facility and had statistically significantly lower total hospital cost than those who received the Triathlon implant
To date the large majority of studies comparing the Attune TKA to other implants have used the PFC Sigma TKA as a comparator Most of these studies have examined cemented implants only A retrospective review comparing 114 PFC Sigma cemented and 103 Attune cemented TKAs with a mean follow-up of 32 years found similar rates of patellar crepitus clunk and anterior knee pain There were also no clinically significant differences in ROM pain or Knee Society Score KSS between the two groups Another retrospective review compared migration of the cemented Attune fixed bearing CR tibial component with the cemented PFC-sigma fixed bearing CR tibial component The overall migration at two years of both groups 38 Attune and 36 PFC Sigma was comparable mean 113 mm 95 CI 097 to 130 for the Attune and 116 mm 95 CI 099 to 135 for the PFC-sigma At two years the mean backward tilting was -043 95 CI -065 to -021 for the Attune and 008 95 CI -016 to 031 for the PFC-sigma The clinical outcomes and Patient Reported Outcome Measures PROMs Knee injury and Osteoarthritis Outcome Score KOOS pain scores KSS and Oxford Knee Score OKS improved between pre-operation and two years post-operation and were not significantly different between groups Radiolucent lines RLLs at the implant-cement interface were mainly seen below the medial tibial baseplate in 17 of the Attune patients and 3 of the PFC-sigma patients at two weeks no significant difference and at two years 42 and 9 of patients respectively p0001 All implant-cement interface radiolucencies were less than 2 mm It was noted that the version of the Attune tibial component examined in this study had since undergone modification by the manufacturer In a further randomised controlled trial of 80 cemented Attune and 78 cemented PFC Sigma TKAs there were no significant differences found in post-operative KSS Western Ontario and McMaster Universities Osteoarthritis Index WOMAC ROM or Visual Analogue Scale VAS pain score between the two groups at 2-year follow-up Both groups showed significantly improved outcomes 2 years after surgery
Thirty TKA patients 15 Attune and 15 Sigma both CR FB with a KOOS70 and at least 1 year post-operation were assessed during five complete cycles of level walking stair descent 018-m steps deep knee bend and sitting down onto and standing up from a chair using a moving fluoroscope 25 Hz 1 ms shutter time Kinematic data were extracted by 2D3D image registration The results demonstrated similar tibiofemoral ranges of motion for flexion-extension abduction-adduction internal-external rotation and anteroposterior AP translation for both groups The pattern of AP translation-flexion-coupling differed between the two groups The subjects with the Sigma TKA showed a sudden change in direction of AP translation around 30º of flexion which was not present in the subjects with the Attune patients
Musgrave Park Hospital MPH is one of the largest Orthopaedic centres in the United Kingdom UK performing more than 1000 primary TKAs annually It is part of the Belfast Health and Social Care Trust BHSCT in Northern Ireland Nearly 1000 Attune TKAs have been performed in MPH since 2022 with over 1000 cementless Triathlons in more recent years
MPH has a Compact Tandem Force-Sensing Treadmill DBCEEWI-CE AMTI Force and Motion Watertown MA USA capable of measuring vertical anteroposterior and mediolateral forces and moments It can measure 6 ground reaction force components FxFyFz MxMyMz with a variable speed of 0-18 Kmh linearity of 05 full scale output hysteresis of 05 full scale output and maximum inclination 25 grade This study will be in collaboration with Professor Justin Cobbs research team in Imperial College London who have established expertise in this form of gait analysis The Total or Partial Knee Arthroplasty Trial TOPKAT randomised controlled trial which included 264 total and 264 partial knees reported no significant differences in OKS between the two groups At MPH a subgroup of these patients 16 total knees 11 partial knees and 16 volunteers with no knee replacements completed post-operative gait analysis at a mean of 45 years following surgery Analysis of this data showed no differences in gait symmetry between the two groups during level downhill and uphill walking Both groups demonstrated similar gait profiles during the three walking conditions to that of the healthy volunteers
Design features of Attune vs Triathlon There are two key design features which are different between the Attune and Triathlon TKAs
1 Coronal stability due to sagittal kinematics design The Attune knee has a Gradually-Reducing radius of curvature termed the Attune Gradius curve from 5-65º flexion The Triathlon has a Single Radius design from 10-110º flexion
2 Sagittal AP stability variation due to Triathlons Rotatory Arc which attempts to achieve some rotational freedom to compensate for the Single Radius design but comes at the expense of increased AP laxity
Rationale for the Study To date there has been a paucity of literature on the Attune TKA as it is still a relatively new implant Worldwide the Triathlon is widely used and is also a well-established successful implant used in the investigators unit The single radius of the Triathlon may provide a less stable knee joint compared to the gradually reducing curve of the Attune knee which provides AP stability and greater ROM The Triathlon TKA has approximately 56 mm of AP laxity but the literature suggests 10 mm of AP laxity is associated with a reduction in functional outcome scores Therefore the primary outcome of gait analysis is being used in this study as a more sensitive measure of knee function Both the Attune and Triathlon TKAs have been designed with a similar evolution of the trochlear geometry - both are asymmetric laterally This study will be able to determine whether the Attune can improve patient outcomes in terms of gait analysis patient reported outcome measures and radiological outcomes Based on previous work from Professor Justin Cobbs research team in Imperial College London it is postulated that gait analysis assessed on a decline will demonstrate a difference between the aforementioned Attune and Triathlon design philosophies
Registry figures regarding the Attune Knee System are promising The 2020 figures from the National Joint Registry NJR for England Wales Northern Ireland and the Isle of Man show that the cumulative revision rate for the Attune knee fixed bearing was 27 95 confidence interval CI 232-317 at 5 years ie implant survivorship at 5 years of 973 out of 25723 knee joints The cumulative revision rate for the Attune knee rotating platform RP was 17 95 CI 117-250 at 5 years ie implant survivorship at 5 years of 983 out of 4254 knee joints Figures from the Australian Orthopaedic Association National Joint Replacement Registry AOANJRR 2020 Report show that the 5-year cumulative revision rate of the Attune Cruciate Retaining implant was 30 95 CI 27 to 35 out of 15300 knees The 5-year cumulative revision rate of the Attune Posterior Stabilized PS implant was 26 95 CI 21 to 33 out of 7179 knees
The Attune cementless Rotating Platform was first implanted in September 2016 and by February of 2021 over 22000 have been implanted worldwide There are only a small number of studies regarding the Attune implant due to its infancy In 2004 the first Triathlon total knee Stryker was implanted The Triathlon knee was designed to address the main reasons for revision surgery such as instability patellofemoral tracking complications and looseningosteolysis There are cruciate-retaining condylar-stabilising posterior-stabilising and difficult primary options available The single radius design allows for mid-flexion stability Over 3 million Triathlon knees have been implanted worldwide
Joint registries show a high rate of survivorship of the Triathlon with over 10 years of follow up The 2020 figures from the NJR for England Wales Northern Ireland and the Isle of Man show that the cumulative revision rate for the Triathlon was 22 95 CI 210-220 at 5 years ie implant survivorship at 5 years of 978 and 34 95 CI 318-356 at 10 years ie implant survivorship at 10 years of 966 out of 133729 knee joints Figures from the AOANJRR 2020 Report show that the cumulative revision rate of the Triathlon CR implant was 25 95 CI 24 to 27 at 5 years and 39 95 CI 37 to 42 at 10 years out of a total 50402 knees The cumulative revision rate of the Triathlon PS implant was 40 95 CI 36 to 45 at 5 years and 61 95 CI 55 to 69 at 10 years out of a total 8755 knees
To the investigators knowledge the only study to compare the Attune and Triathlon TKAs was a retrospective cohort analysis in 2018 using cemented components The Attune implant was received by 1178 patients whilst the Triathlon implant was received by 5707 patients Patients who received the Attune TKA had a statistically significantly shorter length of stay and operating room time were statistically significantly less likely to be discharged to a skilled nursing facility or other inpatient facility and had statistically significantly lower total hospital cost than those who received the Triathlon implant
To date the large majority of studies comparing the Attune TKA to other implants have used the PFC Sigma TKA as a comparator Most of these studies have examined cemented implants only A retrospective review comparing 114 PFC Sigma cemented and 103 Attune cemented TKAs with a mean follow-up of 32 years found similar rates of patellar crepitus clunk and anterior knee pain There were also no clinically significant differences in ROM pain or Knee Society Score KSS between the two groups Another retrospective review compared migration of the cemented Attune fixed bearing CR tibial component with the cemented PFC-sigma fixed bearing CR tibial component The overall migration at two years of both groups 38 Attune and 36 PFC Sigma was comparable mean 113 mm 95 CI 097 to 130 for the Attune and 116 mm 95 CI 099 to 135 for the PFC-sigma At two years the mean backward tilting was -043 95 CI -065 to -021 for the Attune and 008 95 CI -016 to 031 for the PFC-sigma The clinical outcomes and Patient Reported Outcome Measures PROMs Knee injury and Osteoarthritis Outcome Score KOOS pain scores KSS and Oxford Knee Score OKS improved between pre-operation and two years post-operation and were not significantly different between groups Radiolucent lines RLLs at the implant-cement interface were mainly seen below the medial tibial baseplate in 17 of the Attune patients and 3 of the PFC-sigma patients at two weeks no significant difference and at two years 42 and 9 of patients respectively p0001 All implant-cement interface radiolucencies were less than 2 mm It was noted that the version of the Attune tibial component examined in this study had since undergone modification by the manufacturer In a further randomised controlled trial of 80 cemented Attune and 78 cemented PFC Sigma TKAs there were no significant differences found in post-operative KSS Western Ontario and McMaster Universities Osteoarthritis Index WOMAC ROM or Visual Analogue Scale VAS pain score between the two groups at 2-year follow-up Both groups showed significantly improved outcomes 2 years after surgery
Thirty TKA patients 15 Attune and 15 Sigma both CR FB with a KOOS70 and at least 1 year post-operation were assessed during five complete cycles of level walking stair descent 018-m steps deep knee bend and sitting down onto and standing up from a chair using a moving fluoroscope 25 Hz 1 ms shutter time Kinematic data were extracted by 2D3D image registration The results demonstrated similar tibiofemoral ranges of motion for flexion-extension abduction-adduction internal-external rotation and anteroposterior AP translation for both groups The pattern of AP translation-flexion-coupling differed between the two groups The subjects with the Sigma TKA showed a sudden change in direction of AP translation around 30º of flexion which was not present in the subjects with the Attune patients
Musgrave Park Hospital MPH is one of the largest Orthopaedic centres in the United Kingdom UK performing more than 1000 primary TKAs annually It is part of the Belfast Health and Social Care Trust BHSCT in Northern Ireland Nearly 1000 Attune TKAs have been performed in MPH since 2022 with over 1000 cementless Triathlons in more recent years
MPH has a Compact Tandem Force-Sensing Treadmill DBCEEWI-CE AMTI Force and Motion Watertown MA USA capable of measuring vertical anteroposterior and mediolateral forces and moments It can measure 6 ground reaction force components FxFyFz MxMyMz with a variable speed of 0-18 Kmh linearity of 05 full scale output hysteresis of 05 full scale output and maximum inclination 25 grade This study will be in collaboration with Professor Justin Cobbs research team in Imperial College London who have established expertise in this form of gait analysis The Total or Partial Knee Arthroplasty Trial TOPKAT randomised controlled trial which included 264 total and 264 partial knees reported no significant differences in OKS between the two groups At MPH a subgroup of these patients 16 total knees 11 partial knees and 16 volunteers with no knee replacements completed post-operative gait analysis at a mean of 45 years following surgery Analysis of this data showed no differences in gait symmetry between the two groups during level downhill and uphill walking Both groups demonstrated similar gait profiles during the three walking conditions to that of the healthy volunteers
Design features of Attune vs Triathlon There are two key design features which are different between the Attune and Triathlon TKAs
1 Coronal stability due to sagittal kinematics design The Attune knee has a Gradually-Reducing radius of curvature termed the Attune Gradius curve from 5-65º flexion The Triathlon has a Single Radius design from 10-110º flexion
2 Sagittal AP stability variation due to Triathlons Rotatory Arc which attempts to achieve some rotational freedom to compensate for the Single Radius design but comes at the expense of increased AP laxity
Rationale for the Study To date there has been a paucity of literature on the Attune TKA as it is still a relatively new implant Worldwide the Triathlon is widely used and is also a well-established successful implant used in the investigators unit The single radius of the Triathlon may provide a less stable knee joint compared to the gradually reducing curve of the Attune knee which provides AP stability and greater ROM The Triathlon TKA has approximately 56 mm of AP laxity but the literature suggests 10 mm of AP laxity is associated with a reduction in functional outcome scores Therefore the primary outcome of gait analysis is being used in this study as a more sensitive measure of knee function Both the Attune and Triathlon TKAs have been designed with a similar evolution of the trochlear geometry - both are asymmetric laterally This study will be able to determine whether the Attune can improve patient outcomes in terms of gait analysis patient reported outcome measures and radiological outcomes Based on previous work from Professor Justin Cobbs research team in Imperial College London it is postulated that gait analysis assessed on a decline will demonstrate a difference between the aforementioned Attune and Triathlon design philosophies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None