CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques (CoNCReTe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631267
Recruitment Status : Terminated (Due to poor patient accrual)
First Posted : March 7, 2008
Last Update Posted : November 6, 2014
Information provided by:
Rijnstate Hospital

Brief Summary:


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 manual manipulation) did not find significant difference in radiological and clinical outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction between both techniques


To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction (difficulty of reposition). It is suggested that finger-trap traction causes less pain for patients and is more easy than manual manipulation but have the same radiological and clinical outcome.

Study design:

Randomised controlled intervention study

Study population:

300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation (Colles' fracture) older than 16years coming to the Emergency Medical Department.


One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on their upper arm followed by reduction by dorsal pressure. The other group is manually reduced according to Charnley with traction and "hooking over" of the fracture elements.

Main study parameters/endpoints:

Visual analogue scale of patient and medical satisfaction, percentage of successful primary reductions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Apart for the regular follow-up of patients with distal radius fractures,one extra out-patient visit is necessary to assess functional outcome after three months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments of the fingers, but this risk is in our opinion not higher than in the manual manipulation. It is expected that the finger-trap traction group is more satisfied because this technique seems less traumatic than but as successful as the manual manipulation group.

Condition or disease Intervention/treatment Phase
Colles' Fracture Procedure: Manual Manipulation Procedure: Finger Trap Traction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colles Fractures, Determining the Norm in Closed Reduction Techniques
Study Start Date : July 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Manual Manipulation
Procedure: Manual Manipulation
The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
Active Comparator: 2
Finger Trap Traction
Procedure: Finger Trap Traction
Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.

Primary Outcome Measures :
  1. To determine the difference in satisfaction of both patient and treating doctor between two well-known techniques of fracture reposition provided that both techniques show equal results in clinical and radiological outcome. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To describe the functional outcome after three months, complication rate and osteoporosis rate in an urban community of a level-2 trauma-centre. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00631267

Alysis Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815AD
Sponsors and Collaborators
Rijnstate Hospital
Study Director: Karel Kolkman, MD, surgeon Rijnstate Hospital Arnhem

Responsible Party: Drs K.Kolkman, Rijnstate hospital, arnhem Identifier: NCT00631267     History of Changes
Other Study ID Numbers: LTC-502-141207
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Rijnstate Hospital:
visual-analog scale
functional outcome
radiological outcome

Additional relevant MeSH terms:
Fractures, Bone
Colles' Fracture
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Radius Fractures