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

November 5, 2014 updated by: Rijnstate Hospital

Colles Fractures, Determining the Norm in Closed Reduction Techniques

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 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

Objective:

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.

Intervention:

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Alysis Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Study Director: Karel Kolkman, MD, surgeon, Rijnstate Hospital Arnhem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC-502-141207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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