Trial document




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  DRKS00003342

Trial Description

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Title

Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial

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Trial Acronym

Insite

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients that have sustained a hip fracture in the area of the greater trochanter, the fracture is ether treated with a nail or a plate system on a randomized basis. Results of these two groups are then evaluated regarding the resulting quality of life and surgical results.

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Brief Summary in Scientific Language

This is a multi-center, blinded, randomized controlled trial (RCT) using a parallel design to
investigate the impact of Gamma3 intramedullary nails compared with sliding hip screws on
quality of life, rates of revision surgery, fracture-related adverse events, and fracture healing
among patients with intertrochanteric fractures.

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Organizational Data

  •   DRKS00003342
  •   2012/01/04
  •   2011/10/18
  •   no
  •   Approved
  •   11-138, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1126-6957 
  •   ISRCTN96308751   (International Standard Randomised Controlled Trial Number Register)
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Health Condition or Problem studied

  •   S72.1 -  Pertrochanteric fracture
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Interventions/Observational Groups

  •   Osteosynthesis of trochanteric fracuture using an intramedullary Gamma3 nail
  •   Dynamic Hip Screw Osteosynthesis of a trochanteric fracture
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Health related Quality of life assessed with the Euroquol 5D after 1 year

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Secondary Outcome

a) Revision surgery rates at 1 Mo./ 4 Mo./ 12 Mo.
b) Fracture healing rates at 1 yr.
c) Fracture-related adverse events at 1 Mo./ 4 Mo./ 12 Mo.
d) Health-related quality of life (HRQL), including the Parker mobility score (Mobility) at 1 Mo./ 4 Mo./ 12 Mo. and Harris Hip Score (Hip Function) at 1 Mo./ 4 Mo./ 12 Mo.

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Countries of Recruitment

  •   Germany
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  •   United States
  •   Sweden
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/02/01
  •   768
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

trochanteric fracture necessitation surgical intervention
surgical intervention first 7 days after trauma
informed consent by patient or guardian

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Exclusion Criteria

1. Associated major injuries of the lower extremity
2. Retained hardware around the affected proximal femur.
3. Infection around the proximal femur
4. Patients with disorders of bone metabolism other than osteoporosis
5. Patients with a pathologic fracture.
6. Patients with a fracture AO Type 31-A3.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Stryker Osteosynthesis Clinical Research
    • Mr.  Nils  Reimers 
    • Prof. Küntscher Strasse
    • 24232  Schönkirchen
    • Germany
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    • Universität zu Lübeck
    • Mr.  PD Dr.  Arndt P.  Schulz 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Study Nurse, UK-SH, Campus Lübeck
    • Ms.  Sylvia  Schlottau 
    • Ratzeburger Allee 160
    • 23568  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Stryker Osteosynthesis Clinical Research
    • Mr.  Nils  Reimers 
    • Prof. Küntscher Strasse
    • 24232  Schönkirchen
    • 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.