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Two-year clinical results of a novel load redistribution device for the treatment of medial knee OA

  • Orthopaedic Surgery
  • Published:
Archives of Orthopaedic and Trauma Surgery Aims and scope Submit manuscript

Abstract

Purpose

A potential method to relieve the pain from medial osteoarthritis of the knee is to offload the medial compartment. The Latella™ Knee Implant is a novel device designed to offload the medial compartment. The objective of the Cotera-1 study was to evaluate the preliminary safety and feasibility of the Latella implant to treat patients with medial OA of the knee, by a 2-year follow-up of a prospective multicenter feasibility study (Cotera-1) performed in the Netherlands and UK

Methods

In this first-in-man study, 11 participants received the Latella implant and were followed for 2 years, documenting physician assessment, Patient-Reported Outcome (PRO) scoring (KOOS, IKDC, Kujala, SF-36); Patient Global Assessment (PGA), radiographic analysis and MRI analysis, complications, reoperation rate and hip–knee–ankle axis.

Results

The Latella Knee Implant system proved to be well tolerated and demonstrated a low-risk safety profile up to 24 months post-treatment. A responder analysis was performed of the subjects who still had the Latella implanted at 24-month time point (n = 9). Based on a MCID of eight for KOOS pain sub-scale, 78% of the subjects at the 24 month time point would be considered as responders. Similarly, based on improvement in the medial knee pain compared to baseline using the NRS scale of 1–10, 89% of the subjects at the 24-month time point would be considered as responders. Two patients were revised during follow-up: one for arthrofibrosis and one converted to TKA for progression of OA.

Conclusions

The early clinical experience with the Latella Knee Implant in this pilot feasibility study has been encouraging. It appears to be a safe implant with possible effect on medial OA. Additional studies need to be performed to assess the safety and efficacy of the procedure in a larger patient population.

Level of evidence

II

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Funding

This study was funded by Cotera.

Author information

Authors and Affiliations

  1. Xpert Orthopedie, Laarderhoogtweg 12, 1101 AE, Amsterdam, The Netherlands

    D. Haverkamp, H. M. van der Vis & I. N. Sierevelt

  2. Barts Health NHS Trust, London, UK

    J. Lee, P. Achan & M. Ramachandran

  3. The Royal London Hospital, Whitechapel, London, E1 1BB, UK

    J. Lee, P. Achan & M. Ramachandran

Authors
  1. D. Haverkamp
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  2. H. M. van der Vis
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  3. J. Lee
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  4. P. Achan
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  5. I. N. Sierevelt
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  6. M. Ramachandran
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Corresponding author

Correspondence to D. Haverkamp.

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Conflict of interest

This study was financially supported by Cotera.

Ethical approval

IRB approval was obtained (NL.44476.048.13).

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Haverkamp, D., van der Vis, H.M., Lee, J. et al. Two-year clinical results of a novel load redistribution device for the treatment of medial knee OA. Arch Orthop Trauma Surg 140, 1873–1881 (2020). https://doi.org/10.1007/s00402-020-03390-x

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  • DOI: https://doi.org/10.1007/s00402-020-03390-x

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