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

NCT ID: NCT00631267

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-09-30

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.

Conditions

Colles' Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Manual Manipulation

Group Type: PLACEBO_COMPARATOR

Manual Manipulation

Intervention Type: PROCEDURE

The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.

2

Finger Trap Traction

Group Type: ACTIVE_COMPARATOR

Finger Trap Traction

Intervention Type: PROCEDURE

Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.

Interventions

Manual Manipulation

The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.

Intervention Type: PROCEDURE

Finger Trap Traction

Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rijnstate hospital, arnhem

Principal Investigators

Karel Kolkman, MD, surgeon

Role: STUDY_DIRECTOR

Rijnstate Hospital Arnhem

Locations

Alysis Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 11886903 (View on PubMed)

Other Identifiers

LTC-502-141207

Identifier Type: -

Identifier Source: org_study_id