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

Study Overview
=================
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.

Official Title
-----------------
Colles Fractures, Determining the Norm in Closed Reduction Techniques

Conditions
-----------------
Colles' Fracture

Intervention / Treatment
-----------------
* Procedure: Manual Manipulation
* Procedure: Finger Trap Traction


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiological outcome, reduction, satisfaction, visual-analog scale, complications, functional outcome