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

Iain McNamara; Valerie Pomeroy; Allan B Clark; Graham Creelman; Celia Whitehouse; J Wells; B Harry; Toby O Smith; Juliet High; Ann Marie Swart; Celia Clarke

doi:10.1136/bmjopen-2022-061648

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. 2023 Jan 4;13(1):e061648. doi: 10.1136/bmjopen-2022-061648.

Authors

Iain McNamara^{1

2}, Valerie Pomeroy², Allan B Clark³, Graham Creelman⁴, Celia Whitehouse⁵, J Wells², B Harry⁶, Toby O Smith⁷, Juliet High⁸, Ann Marie Swart^{2

9}, Celia Clarke²

Affiliations

¹ Norfolk and Norwich University Hospital, Norwich, UK iain.mcnamara@nnuh.nhs.uk.
² University of East Anglia, Norwich, UK.
³ Norwich Medical School, University of East Anglia, Norwich, UK.
⁴ Mental Health Act Review Panels, Norfolk and Suffolk, UK.
⁵ Norfolk and Norwich University Hospital, Norwich, UK.
⁶ Department of clinical neurosciences, University of Cambridge, Cambridge, UK.
⁷ Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
⁸ Norwich Clinical Trials Unit, Norwich, UK.
⁹ Health Sciences, University of East Anglia, Norwich, UK.

Abstract

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.

Keywords: Clinical trials; HEALTH ECONOMICS; Knee; ORTHOPAEDIC & TRAUMA SURGERY; REHABILITATION MEDICINE.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Arthroplasty, Replacement, Knee*
Humans
Motor Disorders*
Osteoarthritis, Knee* / surgery
Postural Balance
Time and Motion Studies
Treatment Outcome