Trial document




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  DRKS00013308

Trial Description

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Title

In vivo study of a medial stabilizing total knee replacement for analysis of postoperative knee stability and patient satisfaction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The knee arthroplasty provides a wide variety of design variants for total knee arthroplasty systems. The variants are divided by the different ways of coupling between the femur and the tibial sliding surface.
Modern knee prostheses aim to restore a postoperatively natural joint kinematics. One approach here is the so-called medial stabilizing design (MS design). In this design, the medial compartment is a high degree of congruence between the femoral component and the inlay, whereas in the lateral compartment there is no congruence to allow a lateral gliding. The medial convexity of the inlay should allow a lateral translation around the medial pivot point in the knee joint flexion and thus bring about a more physiological kinematics of the artificial knee joint. In addition, this mechanism should produce anterior-posterior stability in the knee joint.
However, a direct in vivo comparison with additional movement-specific analyzes regarding the knee stability between a cruciate-retaining (CR) and medial-stabilized prosthesis (MS) is still missing and could provide initial indications, if the different implementation of the knee-joint stability by design has an influence on the patient's satisfaction.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013308
  •   2017/12/05
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  •   yes
  •   Approved
  •   17-130, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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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

  •   Patients who will receiving a TKA will be treated with medial stabilizing prosthesis design (MS design)
  •   Patients who will receiving a TKA will be treated with a Cruciate Retaining (CR) design
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Measurement of knee stability/instability using EMG, gait parameters and knee stability scale (1-10)
The data are measured pre-operatively and 6, 12 and 24 weeks postoperatively according to the following tasks:
- 100 meter walk
- direction change during walking
- go upstairs
- go downstairs
- get up from the chair

Used muscle groups:
- lateral quadrizeps (vastus lateralis)
- medial quadrizeps (vastus medialis)
- lateral hamstrings (biceps femoris)
- lateral gastrocnemius
- medial hamstrings (semitendinosus)
- medial gastrocnemius
- glutaeus maximus

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Secondary Outcome

Patient satisfaction with three questionnaires, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Forgotten Knee Joint Score (FJs-12), and the UCLA Activity Score.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/12
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Planned total knee arthroplasty

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Exclusion Criteria

- 10 ° varus / valgus deformity
- Strong knee osteoarthritis on the "healthy" leg
- Disruption of the gait pattern
- Low fitness status (treadmill study)
- Language skills (German questionnaires)

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Addresses

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    • Labor für Biomechanik & Experimentelle OrthopädieKlinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation, Klinikum der Universität München, LMU München
    • Mr.  Dr. rer. biol. hum. Dipl.-Ing. (FH)  Matthias  Woiczinski 
    • Fraunhoferstr. 20
    • 82152  Planegg
    • Germany
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    • Labor für Biomechanik & Experimentelle OrthopädieKlinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation, Klinikum der Universität München, LMU München
    • Mr.  Dr. rer. biol. hum.  Matthias  Woiczinski 
    • Fraunhoferstr. 20
    • 82152  Planegg
    • Germany
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    • Labor für Biomechanik & Experimentelle OrthopädieKlinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation, Klinikum der Universität München, LMU München
    • Mr.  Dr. rer. biol. hum.  Matthias  Woiczinski 
    • Fraunhoferstr. 20
    • 82152  Planegg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinischen Fakultät der LMU München
    • Förderprogramm für Forschung und Lehre (FöFoLe) 
    • Bavariaring 19
    • 80336  München
    • Germany
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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.