Trial document




This trial has been registered retrospectively.
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  DRKS00011269

Trial Description

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Title

Outcome after Advanced Core Decompression

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Trial Acronym

ACD

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URL of the Trial

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Brief Summary in Lay Language

“Advanced Core Decompression” (ACD) is a new technique for treatment of osteonecrosis of the femoral head (ONFH) that includes removal of the necrotic tissue using a percutaneous expandable reamer followed by refilling of the drill hole and the defect with an injectable, hard-setting, composite calcium sulphate (CaSO4)-calcium phosphate (CaPO4) bone graft substitute. As autologous bone has been shown to be superior to all other types of bone grafts, the aim of the study is to present and evaluate a modified technique of ACD with impaction of autologous bone derived from the femoral neck into the necrotic defect. The aim of the study is to evaluate the clinical and radiological outcome after modified Advanced Core Decompression. The primary outcomes the hip survival rate 5 years postoperative with an annual survey. Moreover clinical parameters (Harris-Hip-score and VAS) should be evaluated. MRI will be used to evaluate the bone-remodeling and healing of the osteonecrosis

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Brief Summary in Scientific Language

Clinical and radiological outcome after Advanced Core Decompression

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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

  •   DRKS00011269
  •   2016/11/14
  •   [---]*
  •   yes
  •   Approved
  •   10-4293, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M87.95 -  [generalization M87.9: Osteonecrosis, unspecified]
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Interventions/Observational Groups

  •   Patients who suffering from osteonecrosis of the femoral head (stage ARCO I-III) undergo modified Advanced Core Decompression with addition of autologous bone (intervention).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Hip survival rate 5 years postoperative.
Annual survey.

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Secondary Outcome

Clinical and radiological outcome 5 years postoperative.
Annual survey.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/11/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Stage ARCO 1-3

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Exclusion Criteria

Stage ARCO 4 and higher.
Osteoarthritis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Essen
    • Mr.  Priv.-Doz. Dr. med.  Stefan  Landgraeber 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  Priv.-Doz. Dr. med.  Stefan  Landgraeber 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen
    • Mr.  Priv.-Doz. Dr. med.  Stefan  Landgraeber 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • 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.