Trial document




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  DRKS00000739

Trial Description

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Title

Clinical Investigation of "Femur First Workflow" for computer-assisted navigation in total hip arthroplasty

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study will provide a comparison for the implantation of artificial hip joints. A conventional
surgical technique is used for the first group whereas a computer-assisted method is applied to the second group of patients. The latter automatically calculates a position of the implants,
which targets on an optimal mobility of the joint after surgery. The primary goal of the study is to assess whether the joint’s range-of-motion can be improved by the new method. Second, the clinical and radiological outcome will be evaluated

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Brief Summary in Scientific Language

The basic goal of this study is a prospective randomized clinical trial comparing the results between conventional non-navigated Total Hip Arthroplasty (THA) and navigated THA using a new developed Femur First workflow based on an algorithmic optimization of the cup position. In particular, functional parameters (incl. range-of-motion) are analyzed according to a blinded and partially automated evaluation of post-operative CT scans.

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Organizational Data

  •   DRKS00000739
  •   2011/05/02
  •   [---]*
  •   no
  •   Approved
  •   10-121-0263, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   M16.1 -  Other primary coxarthrosis
  •   M16.3 -  Other dysplastic coxarthrosis
  •   M16.5 -  Other post-traumatic coxarthrosis
  •   M16.7 -  Other secondary coxarthrosis
  •   M16.9 -  Coxarthrosis, unspecified
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Interventions/Observational Groups

  •   Navigation assisted placement of primary Hip Total Endoprosthesis
  •   Conventional placement of primary Hip Total Endoprosthesis
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Approx. 6-8 weeks postoperatively, a pelvic/femoral CT scan will be perfomed. Then, the postoperative range-of-motion/ROM of the treated hip joint until bony or metal impingement will be determined. For this purpose, the bone structures will be segmented in the post-operative CT data set. Based on the segmented bone models, the postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements.

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Secondary Outcome

Based on a postoperative CT scan of the hip and femur, additional evaluation will be performed. The variability of the cup position using conventional or computer-assisted implantation will be analyzed by measuring the cup position in the post-operative CT data sets. The accuracy of the image-free navigation procedure for cup and shaft placement will be assessed by comparing the intraoperatively acquired implant positions with measurements in the postoperative CT data. A pre- and post-operative clinical examination including various scores for total hip arthroplasty (Harris Hip Score, HOOS etc.), life quality (SF 36, EuroQol), and pain (visual analog scale 1-10) will be used.

A pre- and post-operative (6 months-1 year)gait analysis using a gait laboratory and a musculoskeletal model will be performed for a subset of patients (40-60). Hip reaction forces, hip angle variation, implant-bone contact stress and muscle forces/activation will be evaluated with the help of the AnyBody Managed Model Repository (AMMR 2009). In order to apply motion to the model marker position trajectories of gait laboratory experiments are used.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/06/16
  •   133
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   75   Years
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Additional Inclusion Criteria

• Indication for total hip arthroplasty due to coxarthrosis
• Physical condition to receive total hip arthroplasty;
• Patient consent to study procedures (incl. post-operative CT)

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Exclusion Criteria

• Patient age < 50 and > 75;
• Hip implant present on the contralateral side;
• Termination of navigated procedure due to technical difficulties

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Addresses

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    • Brainlab AG
    • Kapellenstrasse 12
    • 85622  Feldkirchen
    • Germany
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    • BrainLAB AG
    • Ms.  Dipl Ing  Sabine  Gneiting 
    • Kapellenstrasse 12
    • Germany
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    • Orthopädische Klinik für die Universität Regensburg, Asklepios Klinikum Bad Abbach
    • Mr.  Priv. Doz. Dr. med.  Tobias  Renkawitz 
    • Kaiser Karl V. Allee 3
    • 93077  Bad Abbach
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn BMBF
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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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.