Trial document




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  DRKS00010872

Trial Description

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Title

Prospective validation of the prognostic biomarker CD8+ TEMRA cells for disturbed fracture healing.

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Trial Acronym

BioBone

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URL of the Trial

[---]*

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Brief Summary in Lay Language

10-15% of all fracture patients suffer from an impaired fracture healing process, resulting in a delayed or even non-union.
These patients require additional surgical interventions, associated with prolonged hospitalization/rehabilitation time and productivity losses representing a serious socioeconomic problem. There are no prognostic methods for early prediction of patients at risk of disturbed fracture healing.

We aim to perform a prospective clinical biomarker trial to validate the CD8+TEMRA cell profile as a predictive marker for the healing outcome of fracture patients.
We assume that i) the CD8+ TEMRA cell profile is a prognostic marker with a high diagnostic accuracy to distinguish between disturbed and normal fracture healing, and ii) the sensitivity and specificity of this biomarker is sufficiently high, health economically meaningful and feasible in a clinical routine application.

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Brief Summary in Scientific Language

We aim to perform the prospective biomarker validation study in a realistic (“routine-adapted”) clinical setting. Thus, all study visits are part of the clinical routine, including the radiological and clinical evaluationof the patients. Blood samples for CD8+ TEMRA cell expression will be taken at the patient’s stationary admittance. Healing
progress will be monitored via x-ray/functional tests during the following clinical visits and the SF-36 will assess the patients quality of life. The first study endpoint (delayed healing) is after 18 weeks post surgery, the second endpoint (non-Union) after 36 weeks post surgery. The validation of the biomarker will be performed in a blinded procedure, using the predefined cut-off Level and the healing Status of the Patient at the respective study time Point.

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Organizational Data

  •   DRKS00010872
  •   2016/07/26
  •   [---]*
  •   yes
  •   Approved
  •   EA2/096/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   S82.1 -  Fracture of upper end of tibia
  •   S82.2 -  Fracture of shaft of tibia
  •   S82.3 -  Fracture of lower end of tibia
  •   S82.7 -  Multiple fractures of lower leg
  •   S82.11 -  [generalization S82.1: Fracture of upper end of tibia]
  •   S82.18 -  [generalization S82.1: Fracture of upper end of tibia]
  •   S82.31 -  [generalization S82.3: Fracture of lower end of tibia]
  •   S72 -  Fracture of femur
  •   S72.1 -  Pertrochanteric fracture
  •   S72.2 -  Subtrochanteric fracture
  •   S72.3 -  Fracture of shaft of femur
  •   S72.4 -  Fracture of lower end of femur
  •   S72.7 -  Multiple fractures of femur
  •   S72.8 -  Fractures of other parts of femur
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Interventions/Observational Groups

  •   We pre-surgery assess the CD8+TEMRA cell expression in all long bone fracture patients treated with an osteosynthesis. Within the post-surgery clinical routine visits, the healing Status of the Patient will be assessed by x-ray and functional analyses. The Validation of the biomarker will be performed using the predefined CD8+TEMRA cell Expression cut-off Level and the healing outcome of the Patient at the study endpoints.

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Characteristics

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

Fracture healing status 18 weeks post surgery.
Radiogical analyses to assess the size of the fracture gap and the implant stability as well as functional tests.
Definition of a delayed healing based on the radiological criteria:
a) An incomplete fracture healing or the absence of visible bone consolidation.
b) The presence of a resorption zone or incomplete callus formation.
c) An incomplete bridging, which means one to three cortices bridged.
d) No bridging, which means no cortex is bridged

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Secondary Outcome

fracture healing status 36 weeks post surgery.
Radiological analyses to assess the size of the fracture gap, the bone consolidation and the implant stability as well as functional tests.

The definition of a non-union is fullfilled if the patient meet one or more of the following criteria:
a) no fracture consolidation within 9 months following injury.
b) no signs of fracture consolidation over a three-month period
c) no signs of fracture consolidation within 5 months after initial surgery in the event of implant failure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2016/12/01
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

full Age (18+),
contractually capable,
patient who understand the informed consent + signed consent,
fracture of the Long bones,
surgery Treatment = osteosynthesis,
patient was mobilised before the fracture/surgery occured

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Exclusion Criteria

periprothetic fractures,
pathological fractures,
active Tumor disease,
active Tumor therapy/Treatment,
HIV, Hepatitis B and/or C positive,
drug-dependent person
psyschological disease,
pregnant or nursing Person,
participation in another, parallel running interventional study

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Addresses

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    • Charité Universitätsmedizin Berlin / Berlin-Brandenburger Centrum für Regenerative Therapien / Julius Wolff Institut
    • Mr.  Dr. rer. medic.  Simon  Reinke 
    • Augustenburger Platz 1, Südstr. 2
    • 13353  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin / Berlin-Brandenburger Centrum für Regenerative Therapien / Julius Wolff Institut
    • Mr.  Dr. rer. medic.  Simon  Reinke 
    • Augustenburger Platz 1, Südstr. 2
    • 13353  Berlin
    • Germany
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    • Charité UniversitätsmedizinBerlin / Berlin-Brandenburger Centrum für Regenerative Therapien / Julius Wolff Institut
    • Mr.  Dr. rer. medic.  Simon  Reinke 
    • Augustenburger Platz 1, Südstr. 2
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 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.