Trial document





This trial has been registered retrospectively.
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  DRKS00013753

Trial Description

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Title

Manual versus Robotic Unikondylar Knee Arthroplasty. A prospective pair matched trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients indicated and scheduled for primary unicompartimental knee arthroplasty are enrolled in the study. A critical parameter in unicompartimental arthroplasty is the exact position of the implants and reconstruction of the individual limb alignment. Therefore, different methods are established like conventional manual technique with radiogram based planning or robotic-assisted surgery with preoperative three-dimensional CT-based planning. In the study, patients are assigned to either robotic-assisted or conventional surgery by availability of the method. All participating patients are brought together in comparable pairs in order to improve the comparison. The outcome of both methods is compared collecting patient satisfaction scores, knee function scores and gait analysis data as well as the radiographic outcome and specific complications. 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

The study design is a prospective trial not influencing the clinical routine of either robotic assisted or conventional manual unicompartimental knee arthroplasty. It is a non-invasive observation of the clinical process and outcome so that it is a study according to §23b MPG. As the assignment to one or the other treatment arm is not part of the study, it is not a randomized design. The treatment decision is chosen by the availability of the technology. Two groups are pair matched and compared with 40 patients per group. The follow-up corresponds to the standard after care routine at 3, 6, 12 and 24 months.

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Organizational Data

  •   DRKS00013753
  •   2019/04/08
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  •   yes
  •   Approved
  •   3344-2016, 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 Unikondylar Knee Arthroplasty
    Operation method: manual implantation
  •   Implantation of a Unikondylar Knee Arthroplasty
    Operation method: robotic-assisted version (Stryker MAKO® surgical robot)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   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
  •   2016/09/26
  •   80
  •   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 the medial carriage in medial gonarthrosis, UCLA Activity Score 5 or more, age 18 years 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 Hochschule im Annastift
    • Mr.  Dr.  Max  Ettinger 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule im Annastift
    • Mr.  Dr.  Max  Ettinger 
    • Anna-von-Borries-Str. 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 ongoing
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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.