Trial document




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  DRKS00013892

Trial Description

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Title

Clinical and functional outcome of the GEMINI SL Fixed Bearing PS Knie-Endoprothese in short-, mid- and longterm follow-up

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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

Aim of the PMCF is to confirm the longterm safety and performance of GEMINI SL Fixed Bearing PS knee prothesis which is already CE certificated and sold for several years in a multicentre study.

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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

  •   DRKS00013892
  •   2018/01/19
  •   [---]*
  •   no
  •   Approved
  •   AS 157(bB)/2017, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
  •   M87.06 -  [generalization M87.0: Idiopathic aseptic necrosis of bone]
  •   M87.26 -  [generalization M87.2: Osteonecrosis due to previous trauma]
  •   M87.96 -  [generalization M87.9: Osteonecrosis, unspecified]
  •   M12.06 -  [generalization M12.0: Chronic postrheumatic arthropathy [Jaccoud]]
  •   M12.56 -  [generalization M12.5: Traumatic arthropathy]
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Interventions/Observational Groups

  •   All patients which are foreseen for an implantation of the GEMINI SL Fixed Bearing PS knee prosthesis, are potential participants of the study. If the patient give informed consent to praticipate in the study, he will be invited to 6 months, 1 and 3 years follow-ups after after initial surgery. Additionally, the patient will be called for an telephone interview after 5 and 10 years.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

10-year survival rate of the GEMINI SL Fixed Bearing PS with revision for any reason as the endpoint

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Secondary Outcome

6 month, 1-, 3. and 5 -year survival rate of the GEMINI SL Fixed Bearing PS with revision for any reason as the endpoint
Evaluation of the functional and clinical outcome from pre- to postoperative follow-ups after 6 month, 1-, 3, 5 and 10-years by using the KSS score
- Complications and revisions

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/24
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Signed Patient informed consent
- Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
- age between 18 and 75 years

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Exclusion Criteria

- Body Mass Index (BMI) > 40 kg/m2
- poor general health with an expected life expectation under 5 years
- known comorbidities and medical conditions, which foreseeable affect the clinical and functional outcome of the knee prosthesis, eg. neurological and musculosceletal disorders

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Addresses

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    • Waldemar Link GmbH & Co KG.
    • Barkhausenweg 10
    • 22339  Hamburg
    • Germany
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    • Krankenhaus Märkisch-Oderland, Klinik für Orthopädie , Sportmedizin und Rehabilitation
    • Mr.  Priv.-Doz. Dr. med   Hagen  Hommel 
    • Sonnenburger Weg 3
    • 16269  Wriezen
    • Germany
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    • Waldemar Link GmbH & Co KG.
    • Romy  Spitzmüller 
    • Barkhausenweg 10
    • 22339  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Waldemar Link GmbH & Co KG.
    • Barkhausenweg 10
    • 22339  Hamburg
    • 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.