Trial document





This trial has been registered retrospectively.
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  DRKS00004958

Trial Description

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Title

percutanous volume reduction to the intervertebral disc trough Nukleoplasty

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

measurement of the functional benefit (eg. pain reduction) and the rate of complication (eg. lesion to structures and organs trough the operation) in a group of patients undergoing an operation. This for, patient related data is collected trough questionaires and doctoral reference. The surgical procedure includes the percuanous, needle- guided puncture of the intervertebral disc space and the decompression of the disc through plasma- field- induction. There are not much prospective studies published since now, this for there is a need to know the complication rate and the relationship between the surgical procedure and the functional benefit within different timepoints after surgery.

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Brief Summary in Scientific Language

prospective measurment of the clinical outcome and complication rate after Nucleoplasty for DDD in a 2 year follow- up. Data collection trough the medical staff within the documentation of the regular care and trough questionnaires, provided to the patient.

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Organizational Data

  •   DRKS00004958
  •   2013/05/28
  •   [---]*
  •   yes
  •   Approved
  •   12-180A, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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

  •   M51 -  Other intervertebral disc disorders
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Interventions/Observational Groups

  •   The patients receive pre-/ postoperative a questionnaire including questions towards the functional status (oswestry disability index), pain in different body- regions and patients descriptives (e.g. working status, pain medication intake etc.). The operation, performed under balanaced general anesthesia, include the cannuled, percutanous placement of a probe, which one induces a plasma field within the intervertebral disc space, thus leading to a decompression of the disc.
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Characteristics

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

functional outcome, measures through a patient- based questionnaire, providing the oswestry disability index of the patient, filled out preoperativ and postoperativ after 2 days/ 14 days/ 2 month/ 6 month/ 1 year and 2 years.

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Secondary Outcome

complication rate perioperative, assessed through the data provided by the surgeon and the doctoral reference until the direct dismisson of the patient from the hospital

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

non- sequestred lumbar intervertebral disc prolaps

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Exclusion Criteria

Tumor, local or systemic infection

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Addresses

  • start of 1:1-Block address primary-sponsor
    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • UKSH, Sektion für Orthopädie
    • Mr.  Bastian  Himpe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • 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.