Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial

Objectives To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II).Setting Patients were recruited from an NHS University Hospital between July 2...

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Main Authors: Allan B Clark, Toby O Smith, J Wells, Iain McNamara, Juliet High, Ann Marie Swart, Valerie Pomeroy, Graham Creelman, Celia Whitehouse, B Harry, Celia Clarke
Format: Article
Language:English
Published: BMJ Publishing Group 2023-01-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/1/e061648.full
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author Allan B Clark
Toby O Smith
J Wells
Iain McNamara
Juliet High
Ann Marie Swart
Valerie Pomeroy
Graham Creelman
Celia Whitehouse
B Harry
Celia Clarke
author_facet Allan B Clark
Toby O Smith
J Wells
Iain McNamara
Juliet High
Ann Marie Swart
Valerie Pomeroy
Graham Creelman
Celia Whitehouse
B Harry
Celia Clarke
author_sort Allan B Clark
collection DOAJ
description Objectives To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II).Setting Patients were recruited from an NHS University Hospital between July 2018 and October 2019 with surgery at two sites. Biomechanical and functional capacity measurements were at a University Movement and Exercise Laboratory.Participants 80 participants undergoing single-stage TKR.Interventions Patients were randomised to receive either the Journey II BCS (JII-BCS) or Genesis II TKR.Primary and secondary outcome measures Primary outcome was the Oxford Knee Score (OKS), at 6 months. Secondary outcomes were: OKS Activity and Participation Questionnaire, EQ-5D-5L and UCLA Activity scores, Timed Up and Go Test, 6 min walk test, lower limb kinematics and lower limb muscle activity during walking and balance.Results This study found no difference in the OKS between groups. The OKS scores for the JII-BCS and Genesis II groups were mean (SD) 42.97 (5.21) and 43.13 (5.20) respectively, adjusted effect size 0.35 (-2.01,2.71) p=0.771In secondary outcome measures, the Genesis II group demonstrated a significantly greater walking range-of-movement (50.62 (7.33) vs 46.07 (7.71) degrees, adjusted effect size, 3.14 (0.61,5.68) p=0.02) and higher peak knee flexion angular velocity during walking (mean (SD) 307.69 (38.96) vs 330.38 (41.40) degrees/second, adjusted effect size was 21.75 (4.54,38.96), p=0.01) and better postural control (smaller resultant centre of path length) during quiet standing than the JII-BCS group (mean (SD) 158.14 (65.40) vs 235.48 (176.94) mm, adjusted effect size, 59.91 (–105.98, –13.85) p=0.01.).Conclusions In this study population, the findings do not support the hypothesis that the Journey II BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months after surgery.Trial registration number ISRCTN32315753.
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spelling doaj-art-be7aeda2fcd24e7e931ac2d3a6cbe8872025-02-11T21:10:11ZengBMJ Publishing GroupBMJ Open2044-60552023-01-0113110.1136/bmjopen-2022-061648Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trialAllan B Clark0Toby O Smith1J Wells2Iain McNamara3Juliet High4Ann Marie Swart5Valerie Pomeroy6Graham Creelman7Celia Whitehouse8B Harry9Celia Clarke10Norwich Medical School, University of East Anglia, Norwich, UKNuffield Department of Orthopaedics and Musculoskeletal Sciences, University of Oxford, Oxford, UK1Northern Arizona University, Flagstaff, AZ, USANorfolk and Norwich University Hospital, Norwich, UK3 Norwich Clinical Trials Unit, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, UKNorwich Medical School, University of East Anglia, Norwich, Norfolk, UKprofessor of neurorehabilitationMental Health Act Review Panels, Norfolk and Suffolk, UKNorfolk and Norwich University Hospital, Norwich, UKDepartment of clinical neurosciences, University of Cambridge, Cambridge, UKUniversity of East Anglia, Norwich, UKObjectives To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II).Setting Patients were recruited from an NHS University Hospital between July 2018 and October 2019 with surgery at two sites. Biomechanical and functional capacity measurements were at a University Movement and Exercise Laboratory.Participants 80 participants undergoing single-stage TKR.Interventions Patients were randomised to receive either the Journey II BCS (JII-BCS) or Genesis II TKR.Primary and secondary outcome measures Primary outcome was the Oxford Knee Score (OKS), at 6 months. Secondary outcomes were: OKS Activity and Participation Questionnaire, EQ-5D-5L and UCLA Activity scores, Timed Up and Go Test, 6 min walk test, lower limb kinematics and lower limb muscle activity during walking and balance.Results This study found no difference in the OKS between groups. The OKS scores for the JII-BCS and Genesis II groups were mean (SD) 42.97 (5.21) and 43.13 (5.20) respectively, adjusted effect size 0.35 (-2.01,2.71) p=0.771In secondary outcome measures, the Genesis II group demonstrated a significantly greater walking range-of-movement (50.62 (7.33) vs 46.07 (7.71) degrees, adjusted effect size, 3.14 (0.61,5.68) p=0.02) and higher peak knee flexion angular velocity during walking (mean (SD) 307.69 (38.96) vs 330.38 (41.40) degrees/second, adjusted effect size was 21.75 (4.54,38.96), p=0.01) and better postural control (smaller resultant centre of path length) during quiet standing than the JII-BCS group (mean (SD) 158.14 (65.40) vs 235.48 (176.94) mm, adjusted effect size, 59.91 (–105.98, –13.85) p=0.01.).Conclusions In this study population, the findings do not support the hypothesis that the Journey II BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months after surgery.Trial registration number ISRCTN32315753.https://bmjopen.bmj.com/content/13/1/e061648.full
spellingShingle Allan B Clark
Toby O Smith
J Wells
Iain McNamara
Juliet High
Ann Marie Swart
Valerie Pomeroy
Graham Creelman
Celia Whitehouse
B Harry
Celia Clarke
Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
BMJ Open
title Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
title_full Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
title_fullStr Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
title_full_unstemmed Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
title_short Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial
title_sort comparison of the journey ii bicruciate stabilised jii bcs and genesis ii total knee arthroplasty for functional ability and motor impairment the capability blinded randomised controlled trial
url https://bmjopen.bmj.com/content/13/1/e061648.full
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