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

Status Terminated

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.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00631267
Study type	Interventional
Source	Rijnstate Hospital
Contact
Status	Terminated
Phase	N/A
Start date	July 2008
Completion date	September 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02798614` - Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures	N/A
Completed	`NCT03868696` - Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)	N/A
Recruiting	`NCT00271726` - Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)	N/A
Completed	`NCT00704743` - A Trial Comparing Circumferential Casting Versus Splinting in Displaced Colles' Fractures	Phase 3
Completed	`NCT03859999` - PRediction of Outcome With ED Intervention for Colles Type Wrist Fractures [PREDICT]
Recruiting	`NCT05638360` - Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan	Phase 2
Suspended	`NCT02396277` - Structural and Functional Nerve Changes Following Immobilisation After Distal Radius Fracture - a Pilot Study (NRP)
Completed	`NCT00460733` - SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.	Phase 4
Completed	`NCT02894983` - Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial	N/A
Completed	`NCT00470691` - Dorsal Splint or Circular Cast for Colles' Fracture?	N/A
Not yet recruiting	`NCT04473989` - Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture	Phase 2
Recruiting	`NCT02353065` - Sonographic Assessment of Reduction in Colles' Fracture	N/A
Completed	`NCT02348437` - Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.	N/A
Active, not recruiting	`NCT04716309` - Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).	N/A
Completed	`NCT03014024` - Low-level Laser Therapy in Distal Radius Fractures	N/A
Completed	`NCT00190944` - Effects of Teriparatide on Distal Radius Fracture Healing	Phase 2
Recruiting	`NCT06379490` - Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures	Phase 3
Completed	`NCT02749929` - Low-level Laser Therapy in Wrist Fractures	N/A
Completed	`NCT01518179` - Compression Gloves for Distal Radius Fracture	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms