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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00631267
First received: February 27, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention
Colles' Fracture
Procedure: Manual Manipulation
Procedure: Finger Trap Traction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colles Fractures, Determining the Norm in Closed Reduction Techniques

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631267

Contacts
Contact: Roelie Tijssen, MD +31263788888

Locations
Netherlands
Alysis Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6815AD
Contact: Karel Kolkman, MD, surgeon    +31263788888    KKolkman@alysis.nl   
Principal Investigator: Roelie Tijssen, MD         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Study Director: Karel Kolkman, MD, surgeon Rijnstate Hospital Arnhem
  More Information

Publications:
Responsible Party: Drs K.Kolkman, Rijnstate hospital, arnhem
ClinicalTrials.gov Identifier: NCT00631267     History of Changes
Other Study ID Numbers: LTC-502-141207
Study First Received: February 27, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
reduction
satisfaction
visual-analog scale
complications
functional outcome
radiological outcome

Additional relevant MeSH terms:
Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014