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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Colles Fractures, Determining the Norm in Closed Reduction Techniques

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 as

Detailed Summary:
Sponsor: Rijnstate Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Rijnstate Hospital

Dates:
Date Received: February 27, 2008
Date Started: July 2008
Date Completion:
Last Updated: November 5, 2014
Last Verified: November 2014