Status:
TERMINATED
CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques
Lead Sponsor:
Rijnstate Hospital
Conditions:
Colles' Fracture
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Rationale: Many different closed techniques are used to reduce a dorsally dislocated distal radius fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction and manu...
Eligibility Criteria
Inclusion
- Patients of 16 years and older visiting our EMD with newly diagnosed closed distal radius fractures:
- within 2cm of the radiocarpal joint
- with dorsoradial dislocation (Colles' fractures),
- AO-type 23.A2 and 23.A3 (extra-articular) and 23-C1 and 23-C2 (intra-articular)
- which are in need for reduction. I.e. Colles' fractures:
- with loss of ≥2mm of radial height (RH),
- change of ≥5º of radial inclination (RI),
- loss of ≥10º volar tilt (VT),
- loss of reduction of the distal radioulnar (DRU) joint and/or
- fractures with \>1mm intra-articular step-off
Exclusion
- Patients who will not have their follow-up in our hospital
- Patients \<16 year old
- Greenstick fractures
- Additional fractures of carpalia or elbow joint
- Patients suffering a High Energy Trauma (HET)
- Fractures that do not need reduction (see 4.2 for definition)
- Patients with pre-existent wrist-trauma or pathological bone except for osteoporosis (cyst, metastasis)
- Patients who cannot give informed consent or do not understand the Dutch language
- Patients with bilateral fractures
- Open fractures
- Fractures \>48h old
- (Smith, Barton, reversed Barton or Chauffeurs fractures)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00631267
Start Date
July 1 2008
End Date
September 1 2011
Last Update
November 6 2014
Active Locations (1)
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1
Alysis Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815AD