Clinical Data

Safety, efficacy and survivorship through short, medium and long-term peer-reviewed publications.

The proven solution with a

20 YEAR

Clinical History

Summarised Literary Review over the 6 Peer-Reviewed Clinical Papers

Short, Mid and Long-term Event Summary derived from Published Literature

View Short, Mid and Long-term Event Summary derived from Published Literature

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Author
No. of patients / implants
Follow up time after procedure (avg / range)
Analysis and Findings
Prof. Rajan -Single Centre, UK

30 / 30

16 / 6 - 24 mos.

  • Loosening of phalangeal component requiring revision
  • Osteolysis in phalangeal components (1 required revision)
Prof. Richter (ex-President EFAS) - Single Centre, Germany

25 / 25

45.7 / 25  – 80 mos.

  • 1 poly revision noted in Q1 2020 due to joint tightness
Karpe, Single Centre, UK

28 / 34

27.7 / 7  - 44 mos.

  • 2 minor osteolysis below the metatarsal head at 12 mos. post-op (did not correlate with onset of any new symptoms)
Tunstall (Lead by 2 ex-Presidents of BOFAS), Multi Centre, UK

30 / 33

16.9 / 12  - 29 mos.

  • No lysis seen
Prof. Kofoed (ex-President EFAS), Single Centre, Denmark

80 / 90

11.5 / 7  - 15 yrs

  • No osteolysis or implant loosening observed
  • 1 dislocation (explant)
Wetke, Single Centre, Denmark

12 / 12

3.1 / 1  - 7.2 yrs

  • No failures noted
  • Patients reviewed for effects /improvements in Bone Mineral Density
Total

205/224

50 mos. avg

  • Dislocation: 1 report, resulted in explant
    Event rate: 0.4% (1/224)
    Revision rate: 0.4% (1/224)
  • Osteolysis: 4 reports, 1 required revision
    Event rate: 1.8% (4/224)
    Revision rate: 0.4%  (1/224)
  • Loosening: 1 report. Resulted in explant
    Event rate:     0.4% (1/224)
    Revision rate:     0.4% (1/224)
I. Schmidt – 2015

Prof. Kofoed – 2017

Prof. Richter – 2020

Prof. Rajan – May 2021

Prof. Rajan – July 2021

França – 2021

Prof. Richter – 2022

Overall survivorship statistic of
94.65%
*Toes surviving / Total toes implanted over 20 years
15 year Kaplan-Meier survivorship statistic of
91.2%

Read Prof. Kofoed’s 15 year follow up

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This is the only total MTP joint implant that allows constant adaption of the great toe towards the ground surface under stable conditions due to the rotation between the phalangeal implant and the meniscus.
Professor Hakon Kofoed
ROTOglide offers a practical and well-tested alternative to fusion for those patients wishing to maintain movement in their arthritic great toe.
Mr Patrick Laing & Mr. Chris Walker
The only total joint replacement with positive evidence regarding function and clinical outcome
Prof. Dr. med. Martinus Richter

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