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

Colles' Fracture Clinical Trial

— CoNCReTe  

Official title:

Colles Fractures, Determining the Norm in Closed Reduction Techniques

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00631267
• Other study ID #: LTC-502-141207
• Status: Terminated
• Phase: N/A
• First received: February 27, 2008
• Last updated: November 5, 2014
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: November 2014
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

Procedure:
• Manual Manipulation
The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
• Finger Trap Traction
Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.

Locations

Country	Name	City	State
Netherlands	Alysis Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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-A(3):354-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes