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

NCT00631267 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2014-11-06

No results posted yet for this study

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 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.

Conditions

  • Colles' Fracture

Interventions

PROCEDURE

Manual Manipulation

The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.

PROCEDURE

Finger Trap Traction

Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Karel Kolkman, MD, surgeon · Rijnstate Hospital Arnhem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631267 on ClinicalTrials.gov