CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques (CoNCReTe)
Primary Purpose
Colles' Fracture
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Manual Manipulation
Finger Trap Traction
Sponsored by
About this trial
This is an interventional treatment trial for Colles' Fracture focused on measuring reduction, satisfaction, visual-analog scale, complications, functional outcome, radiological outcome
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)
Sites / Locations
- Alysis Rijnstate Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Manual Manipulation
Finger Trap Traction
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631267
Brief Title
CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques
Acronym
CoNCReTe
Official Title
Colles Fractures, Determining the Norm in Closed Reduction Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to poor patient accrual
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture
Keywords
reduction, satisfaction, visual-analog scale, complications, functional outcome, radiological outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Manual Manipulation
Arm Title
2
Arm Type
Active Comparator
Arm Description
Finger Trap Traction
Intervention Type
Procedure
Intervention Name(s)
Manual Manipulation
Intervention Description
The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
Intervention Type
Procedure
Intervention Name(s)
Finger Trap Traction
Intervention Description
Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Kolkman, MD, surgeon
Organizational Affiliation
Rijnstate Hospital Arnhem
Official's Role
Study Director
Facility Information:
Facility Name
Alysis Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
11886903
Citation
Earnshaw SA, Aladin A, Surendran S, Moran CG. Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):354-8. doi: 10.2106/00004623-200203000-00004.
Results Reference
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CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques
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