McNamara, Iain R., Pomeroy, Valerie ORCID: https://orcid.org/0000-0003-4487-823X, Clark, Allan B. ORCID: https://orcid.org/0000-0003-2965-8941, Creelman, Graham, Whitehouse, Celia E., Wells, Jacob, Harry, Bronwen, Smith, Toby O. ORCID: https://orcid.org/0000-0003-1673-2954, High, Juliet ORCID: https://orcid.org/0000-0003-2555-2349, Swart, Ann Marie ORCID: https://orcid.org/0000-0002-9359-6995 and Clarke, Celia (2023) 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, 13 (1). ISSN 2044-6055
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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=0.771. In 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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