Trial document





This trial has been registered retrospectively.
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  DRKS00012390

Trial Description

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Title

Robotic-assisted versus manual total knee arthroplasty – a non-invasive prospective randomized controlled trial (NIS)

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Trial Acronym

Manuell-MAKO KTEP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients indicated and scheduled for primary total knee arthroplasty are enrolled in the study. The patients are randomized to either ct-based planning and robotic-assisted surgery or conventional radiogram based planning and manual procedure. The outcome of both methods is compared collecting patient satisfaction scores, knee function scores and gait analysis data. Major outcome parameter for power analysis is the standardized Knee Society Score. 65 patients are calculated for each group. The follow-up corresponds to the standard after care routine at 3, 6, 12 and 24 months.

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Brief Summary in Scientific Language

It is a prospective, randomized, controlled study design. The two surgical methods are compared in two groups. For this purpose, 65 patients should be enrolled per group. In order to be able to carry out the operation adequately with the robot-supported method, the surgeons were trained in advance with the handling of the Stryker MAKO robot. For this purpose, max. 10 patients planned and performed the operations. There are max. 65 patients included. The follow-up appointments take place after 3, 6, 12 and 24 months according to the orthopedic routine.

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Organizational Data

  •   DRKS00012390
  •   2019/04/08
  •   [---]*
  •   yes
  •   Approved
  •   7496, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Implantation of a total knee arthroplasty
    Operation method: manual implantation
  •   Operation method: robotic-assisted version (Stryker MAKO® surgical robot)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
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  •   N/A
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Primary Outcome

Accuracy of implantation: comparison of planning and outcome in postoperative routine x-ray.

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Secondary Outcome

KSS (Knee Society Score) and Oxford Knee Score after 24 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/07/27
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Indication for bicondylar resurfacing in primary gonarthrosis, UCLA Activity Score 5 or more, ages 18 and over

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Exclusion Criteria

BMI > 40, history of an infection knee, post-traumatic arthritis, Z.n. Bony Umsetzosteotomie, Chronic Polyarthritis, ASA 3-4, Neurological disease with mobility impairment

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Addresses

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    • Orthopädische Klinik der Medizinischen Hoch-schule Hannover im Annastift
    • Mr.  Prof. Dr. med.  Henning  Windhagen 
    • Anna-von-Borries-Straße 1–7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hoch-schule Hannover im Annastift
    • Mr.  Dr. med.   Tilman  Calließ 
    • Anna-von-Borries-Straße 1–7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Annastift
    • Mr.  Dr. med.  Tilman  Calließ 
    • Anna-von-Borries-Straße 1-7
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Stryker
    • Herikerbergweg 110
    • 1101  Amsterdam
    • Netherlands
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.