Trial document




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  DRKS00004874

Trial Description

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Title

Angulated fractures of the distal forearm in children: is remodeling a therapeutic option?

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Trial Acronym

AFIC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Children (5-11 yrs) with distal angulated forearm fractures will be corrected spontaneously by remodelling or closed reduction and K-wire pinning. The primary objective of this trial is to assess whether long-term functional outcome (2 yrs) in remodelled patients is not inferior to patients receiving closed reduction and K-wire pinning.

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Brief Summary in Scientific Language

Children (5-11 yrs) with distal angulated forearm fractures will be corrected spontaneously by remodelling or closed reduction and K-wire pinning. The primary objective of this trial is to assess whether long-term functional outcome (2 yrs) in remodelled patients is not inferior to patients receiving closed reduction and K-wire pinning.

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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

  •   DRKS00004874
  •   2013/10/30
  •   [---]*
  •   yes
  •   Approved
  •   2013-544N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   angulated distal forearm fracture
  •   S52 -  Fracture of forearm
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Interventions/Observational Groups

  •   Immobilization in cast without reduction
  •   Closed reduction and percutaneous K-wire pinning, cast, patients under narcosis
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cooney-Score after 24 months (dichotomised in ≥90 vs. <90). The Cooney score includes subjective parameters (pain, strength, and activity before and after trauma) as well as objective (flexibility) parameters.

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Secondary Outcome

- Cooney-score after 3 and 12 months;
- patient/parent satisfaction score (ZUF-8 and CHC-SUN modified) after 1, 3, 12 and 24 months;
- grade of radiological displacement at 12/24 months;
- secondary operation (after 24 months);
- secondary reposition (after 24 months);
- secondary K-wire osteosynthesis (after 24 months);
- growth disturbance (after 24 months);
- therapeutic complications (Dindo-Clavien classification, after 24 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2014/04/07
  •   742
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   11   Years
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Additional Inclusion Criteria

- Children 5-11 yrs
- distal forearm fracture
=> 23-M/2-3 or 23-E/1-2 according to AO-classification),
=> angulated radius/forearm fracture in distal third
=> angulated epiphyseolysis with/without metaphyseal wedge
- angulation ≤30°
=> 5-7 yrs angulation 15-30°
=> 8-11 yrs angulation 10-25°
- written informed consent (children and parents)

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Exclusion Criteria

- torus fractures;
- complete displacement with shortening;
- other osteosynthesis than K-wire osteosynthesis necessary;
- neurological concomittant diseases;
- metabolic diseases;
- pathological fracture;
- neurovascular injuries;
- presence of another skeletal injury or serious injuries

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Addresses

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    • Ruprecht-Karls-Universität Heidelberg
    • Ms.  Dr.  Angela  Kalous 
    • Grabengasse 1
    • 69117  Heidelberg
    • Germany
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    • Universitätsklinikum Mannheim
    • Mr.  Prof. Dr.   Lucas M.  Wessel 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin MannheimFakultät für Medizin der Universität Heidelberg
    • Mr.  Prof. Dr.  Lucas M.  Wessel 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • 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 stopped after recruiting started
  •   2018/08/01
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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.