CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques (CoNCReTe)
|ClinicalTrials.gov Identifier: NCT00631267|
Recruitment Status : Terminated (Due to poor patient accrual)
First Posted : March 7, 2008
Last Update Posted : November 6, 2014
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.
Randomised controlled intervention study
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: 1
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631267
|Alysis Rijnstate Hospital|
|Arnhem, Gelderland, Netherlands, 6815AD|
|Study Director:||Karel Kolkman, MD, surgeon||Rijnstate Hospital Arnhem|