Early migration of a medially stabilized total knee arthroplasty : a radiostereometric analysis study up to two years

Frank-David Øhrn, Øystein Bjerkestrand Lian, Masako Tsukanaka, Stephan Maximillian Röhrl, Frank-David Øhrn, Øystein Bjerkestrand Lian, Masako Tsukanaka, Stephan Maximillian Röhrl

Abstract

Aims: Medial pivot (MP) total knee arthroplasties (TKAs) were designed to mimic native knee kinematics with their deep medial congruent fitting of the tibia to the femur almost like a ball-on-socket, and a flat lateral part. GMK Sphere is a novel MP implant. Our primary aim was to study the migration pattern of the tibial tray of this TKA.

Methods: A total of 31 patients were recruited to this single-group radiostereometric analysis (RSA) study and received a medial pivot GMK Sphere TKA. The distributions of male patients versus female patients and right versus left knees were 21:10 and 17:14, respectively. Mean BMI was 29 kg/m2 (95% confidence interval (CI) 27 to 30) and mean age at surgery was 63 years (95% CI 61 to 66). Maximum total point motions (MTPMs), medial, proximal, and anterior translations and transversal, internal, and varus rotations were calculated at three, 12, and 24 months. Patient-reported outcome measure data were also retrieved.

Results: MTPMs at three, 12, and 24 months were 1.0 mm (95% CI 0.8 to 1.2), 1.3 mm (95% CI 0.9 to 1.7), and 1.4 mm (0.8 to 2.0), respectively. The Forgotten Joint Score was 79 (95% CI 39 to 95) and Knee Injury and Osteoarthritis Outcome Score obtained at two years was 94 (95% CI 81 to 100), 86 (95% CI 75 to 93), 94 (95% CI 88 to 100), 69 (95% CI 48 to 88), and 81 (95% CI59 to 100) for Pain, Symptoms, Activities of Daily Living, Sport & Recreation, and Quality of Life, respectively.

Conclusion: In conclusion, we found that the mean increase in MTPM was lower than 0.2 mm between 12 and 24 months and thus apparently stable. Yet the GMK Sphere had higher migration at one and two years than anticipated. Based on current RSA data, we therefore cannot conclude on the long-term performance of the implant, pending further assessment. Cite this article: Bone Jt Open 2021;2(9):737-744.

Keywords: BMI; Contemporary knee arthroplasties; Contemporary knee designs; Forgotten Joint Score; GMK Sphere; Knee arthroplasty; Knee injury and Osteoarthritis Outcome Score (KOOS); Medial pivot; Medially stabilized; Patient-reported outcome measures; RSA; TKA; knees; radiostereometric analysis (RSA); tibial bone; tibial tray; total knee arthroplasties (TKAs); varus.

Conflict of interest statement

ICMJE COI statement: The authors declare an insitutional grant from Mecdata International, paid to the Orthopaedic Department of Ullevaal Hospital, related to this study. F-D. Øhrn declares a PhD scholarship from Møre and Romsdal Health Trust.

Figures

Fig. 1
Fig. 1
a) Global Medacta Knee Sphere (GMK Sphere, anterior view) displaying the congruent medial and flat lateral parts of the insert designed to mimic the native knee motion during flexion and extension. Blue dots indicate position of feature points. b) The posterior view of the same implant displaying the congruent medial and flat lateral parts of the insert designed to mimic the native knee motion during flexion and extension.
Fig. 2
Fig. 2
Flow chart of the study. *Unrelated to the study; this patient already had condition number (CN) > 120. ME, mean error; RSA, radiostereometric analysis.
Fig. 3
Fig. 3
Median Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline to 24 months. ADL, activities of daily living, QoL, quality of life.
Fig. 4
Fig. 4
Individual and mean maximum total point motions (MTPMs) with error bars showing 95% confidence intervals.
Fig. 5
Fig. 5
Peripheral distal and proximal sagittal translations of the different feature points over time.

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