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

Sponsor

Rijnstate Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00631267

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Colles' Fracture	Procedure: Manual Manipulation Procedure: Finger Trap Traction	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2008

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [3 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

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)