Trial document

drksid header

DRKS-ID: DRKS00004874

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

AFIC

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

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.

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

end of 1:1-Block scientific synopsis

start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data

start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00004874
Date of Registration in DRKS: 2013/10/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2013-544N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

[---]*

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

Free text: angulated distal forearm fracture
ICD10: S52 - Fracture of forearm

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: Immobilization in cast without reduction
Arm 2: Closed reduction and percutaneous K-wire pinning, cast, patients under narcosis

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: assessor
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

end of 1:1-Block design

start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

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)

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Kinderchirurgische Klinik, Mannheim
Medical Center Altonaer Kinderkrankenhaus gGmbH, Hamburg
University Medical Center Klinik und Poliklinik für Kinderchirurgie Charité, Berlin
University Medical Center Klinik für Kinderchirurgie, Greifswald
Medical Center Krankenhaus St. Elisabeth und St. Barbara, Halle Saale
University Medical Center Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Homburg Saar
Medical Center Städtisches Klinikum, Karlsruhe
University Medical Center Klinik für Unfallchirurgie, Kiel
Medical Center Kinderchirurgie und -urologie Cnopf'sche Kinderklinik, Nürnberg
Medical Center Klinik für Unfallchirurgie und Orthopädie Ev. Krankenhaus Paul-Gerhardt-Stift, Lutherstadt Wittenberg
Medical Center Krankenhaus Bethanien, Moers
Medical Center Klinikum Memmingen, Memmingen
University Medical Center Universitätsklinikum Carl Gustav Carus, Dresden
University Medical Center Universitätsklinikum Gießen und Marburg GmbH, Marburg
University Medical Center Klinik für Orthopädie und Unfallchirurgie der Albert-Ludwigs-Universität Freiburg, Freiburg im Breisgau
Medical Center Klinikum Schwabing, München
University Medical Center Abteilung für Kinderchirurgie der Universitätsmedizin Rostock, Rostock
Medical Center Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt a.M.
Medical Center Kaiserswether Diakonie Florence-Nightingale-Krankenhaus, Düsseldorf
University Medical Center Universitätsklinik für Kinder- und Jugendmedizin , Tübingen
Medical Center Stiftungsklinikum Mittelrhein GmbH , Koblenz
Medical Center Krankenhaus Barmherzige Brüder Regensburg, Regensburg
University Medical Center Zentrum für Orthopädie und Unfallchirurgie, Mainz
University Medical Center Klinik für Kinderchirurgie und Kinderurologie, Dortmund
Medical Center Vinzenz Palloti Hospital, Bergisch-Gladbach
Medical Center Medizinische Hochschule Unfallchirurgische Klinik, Hannover
Medical Center Diakonissen Krankenhaus Flensburg Klinik für Orthopädie, Unfallchirurgie und Sportmedizin, Flensburg
Medical Center Vivantes Klinikum Neukölln, Berlin
University Medical Center Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Frankfurt a.M.
Medical Center Schwarzwald Baar, Villingen-Schwenningen
Medical Center Klinikum Mutterhaus, Trier
University Medical Center Aachen
University Medical Center Köln

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2014/04/07
Target Sample Size: 742
Monocenter/Multicenter trial: Multicenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 5 Years
Maximum Age: 11 Years

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

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)

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Ruprecht-Karls-Universität Heidelberg
- Ms. Dr. Angela Kalous
- Grabengasse 1
- 69117 Heidelberg
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: 06221 54-2100 und -2101
- Fax: 6221 54-2618
- E-mail: kanzlerin at zuv.uni-heidelberg.de
- URL: http://www.uni-heidelberg.de/einrichtungen/rektorat/angela_kalous.html
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- Universitätsklinikum Mannheim
- Mr. Prof. Dr. Lucas M. Wessel
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
end of 1:1-Block address scientific-contact

start of 1:1-Block address contact scientific-contact
- Telephone: 0621 3835574
- Fax: 0621 3833823
- E-mail: lucas.wessel at medma.uni-heidelberg.de
- URL: http://www.umm.de
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- Universitätsmedizin MannheimFakultät für Medizin der Universität Heidelberg
- Mr. Prof. Dr. Lucas M. Wessel
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
end of 1:1-Block address public-contact

start of 1:1-Block address contact public-contact
- Telephone: 0621 383 5574
- Fax: 0621 383 3823
- E-mail: Lucas.Wessel at medma.uni-heidelberg.de
- URL: http://www.umm.de
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting stopped after recruiting started
Study Closing (LPLV): 2018/08/01

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

[---]*

end of 1:n-Block publications

* This entry means the parameter is not applicable or has not been set.