Trial document




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  DRKS00010775

Trial Description

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Title

Evaluation of the postoperative clinical and fluoroscopical outcome of a kinematic knie endoprosthesis, comparison of operation techniques with and without ligament tensioning against and standard knie endoprosthesis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The relationship between the clinical evolution and the mechanical functionality after a total knee joint arthroplasty is known. The association between the implant components orientation, the postoperative revision, the joint stability, the postoperative pain level and the functionality have been already subject of many studies. On the other side, the threshold between mal- and “normal” alignment is intensively discussed in the literature. A series of different implant developments and design’s optimizations such as modifications in the curvature of the contact areas, a variation in implant sizes have been implemented to solve this problematic. However, in most cases the patient specific alignment, which requires a precise preoperative plan and intraoperative analysis, is not considered. Another aspect would be the precise bone cut during the implantation. Patient specific instrumentation (PSI) allows for a landmark based bone cut which would optimize the preoperative operation plan. All the aforementioned aspects concentrate on the treatment of knee osteoarthritis. It is known however, that the surrounding soft tissue, ligament structures, joint capsule and muscles play all together a big role in the overall joint stabilization, which is to be considered knowing that joint instability is the main cause of revision after total knee arthroplasty. Through the development of a patient’s specific ligament tensioning and orientation technique combined with an anatomical knee prosthesis design would be for the first time the implantation of a biomechanical balanced knee joint replacement possible.
A traditional TC Design will be used as a control, such design has not a physiological joint line but posses a similar basis geometrie.
In order to analyse the influence of the prosthesis design on the pivot changes during the whole movement cycle, patients with a 3DKnee lateral pivot design will also be analysed (Amendment S9 (A)/2016 at 30.08.2016).
To analyse the role of keeping or sacrificing the posterior cruciate ligament as well as the component radius on the femoral rollback and axial rotation of the knee joint, the following patient cohorts will be analysed; cruciate retaining system (Journey II CR), bi-cruciate stabilizing system (Journey II BCS), cruciate retaining multi-radius system (Attune CR) and cruciate stabilizing multi-radius system (Attune PS). (Ethic votum S10(a)/2018 from 17.05.2018)

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Brief Summary in Scientific Language

The relationship between the clinical evolution and the mechanical functionality after a total knee joint arthroplasty is known. The association between the implant components orientation, the postoperative revision, the joint stability, the postoperative pain level and the functionality have been already subject of many studies. On the other side, the threshold between mal- and “normal” alignment is intensively discussed in the literature. A series of different implant developments and design’s optimizations such as modifications in the curvature of the contact areas, a variation in implant sizes have been implemented to solve this problematic. However, in most cases the patient specific alignment, which requires a precise preoperative plan and intraoperative analysis, is not considered. Another aspect would be the precise bone cut during the implantation. Patient specific instrumentation (PSI) allows for a landmark based bone cut which would optimize the preoperative operation plan. All the aforementioned aspects concentrate on the treatment of knee osteoarthritis. It is known however, that the surrounding soft tissue, ligament structures, joint capsule and muscles play all together a big role in the overall joint stabilization, which is to be considered knowing that joint instability is the main cause of revision after total knee arthroplasty. Through the development of a patient’s specific ligament tensioning and orientation technique combined with an anatomical knee prosthesis design would be for the first time the implantation of a biomechanical balanced knee joint replacement possible.
A traditional TC Design will be used as a control, such design has not a physiological joint line but posses a similar basis geometrie.
In order to analyse the influence of the prosthesis design on the pivot changes during the whole movement cycle, patients with a 3DKnee lateral pivot design will also be analysed (Amendment S9 (A)/2016 at 30.08.2016).
To analyse the role of keeping or sacrificing the posterior cruciate ligament as well as the component radius on the femoral rollback and axial rotation of the knee joint, the following patient cohorts will be analysed; cruciate retaining system (Journey II CR), bi-cruciate stabilizing system (Journey II BCS), cruciate retaining multi-radius system (Attune CR) and cruciate stabilizing multi-radius system (Attune PS). (Ethic votum S10(a)/2018 from 17.05.2018)

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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

  •   DRKS00010775
  •   2016/08/05
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  •   yes
  •   Approved
  •   S9(a)/2016, S10(a)/2018, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   Total Knee Arthroplasty
  •   Z96.6 -  Presence of orthopaedic joint implants
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Interventions/Observational Groups

  •   After total knee arthroplasty surgery, recruited patients with a 4 –motion® knee joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measuremente procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on the anatomical joint line of the 4-motion designs, a positive effect on the reached knee lfexion angle is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
  •   After total knee arthroplasty surgery, recruited patients with a TC Plus knee joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measuremente procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on the anatomical joint line of the 4-motion designs, a positive effect on the reached knee lfexion angle is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
  •   After total knee arthroplasty surgery, recruited patients with a 3DKnee lateral pivot joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measurement procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on lateral pivot design, a design-based change in the knee joint kinematic is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
    (Amendment S9 (A)/2016 at 30.08.2016)
  •   After total knee arthroplasty surgery, recruited patients with a Journey II BCS joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measurement procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on lateral pivot design, a design-based change in the knee joint kinematic is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
    (Ethic votum S10(a)/2018 at 17.05.2018)
  •   After total knee arthroplasty surgery, recruited patients with a Journey II CR joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measurement procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on lateral pivot design, a design-based change in the knee joint kinematic is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
    (Ethic votum S10(a)/2018 at 17.05.2018)
  •   After total knee arthroplasty surgery, recruited patients with a Attune CR joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measurement procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on lateral pivot design, a design-based change in the knee joint kinematic is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
    (Ethic votum S10(a)/2018 at 17.05.2018)
  •   After total knee arthroplasty surgery, recruited patients with a Attune PS joint implant will be analysed using single plane fluoroscopy during loaded and unloaded activities. Mesurements will be conducted with an acquisition frecuency of 30 Hz. After explanation and clear understanding of the measurement procedure, the operated knee will be positioned as near as possible of the image intensifier of the fluoroscope. The activities to be measured are an unloaded flexion-extension as well as a loaded lunge. Three repetitions will be collected. Based on lateral pivot design, a design-based change in the knee joint kinematic is expected during the execution of the activities. Additionally, postoperative clinical data will be collected with the clinical questionnaries KSS, High Flexion Knee Score und Forgotten Joint Score.
    (Ethic votum S10(a)/2018 at 17.05.2018)
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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)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Fluoroscopic examination of the knee joint kinematik in patients with three different knie implant designs at 6 and 12 months postoperative

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Secondary Outcome

Examination of the knee joint Range of motion (RoM) with a goniometer and collection of the clinical data with the questionnaries KSS, High flexion knee score and Forgotten joint score preoperative and after 6 and 12 months postoperative.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/10/10
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

•Indication for a total knee arthroplasty after primary and secondary medial knee osteoarthritis
•Patient agreement to participate in the study
•Implantation of the previously described TKA designs

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Exclusion Criteria

Patients with contra indications to total knee arthroplasty

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Addresses

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    • Krankenhaus Märkisch-Oderland GmbH Betriebsteil WriezenKlinik für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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    • Julius Wolff Institut & Berlin-Brandenburg Center for Regenerative TherapiesCharité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr.-Ing.  Georg N.  Duda 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Julius Wolff Institut, Charité Universitätsmedizin Berlin
    • Mr.  Dr.-Ing.  Philippe  Moewis 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Krankenhaus Märkisch-Oderland GmnH, Betriebsteil Wriezen Klinik für Orthopädie und Unfallchirurgie
    • Ms.  Peggy  Hommel 
    • Sonnenburger weg 3
    • 16269  Wriezen
    • Germany
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Sources of Monetary or Material Support

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    • Krankenhaus Märkisch-Oderland GmbH Betriebsteil WriezenKlinik für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med  Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • 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.