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Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)

Radius Fractures Clinical Trial

Official title:
Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires

Clinical Trial Summary

This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.

The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00271726
Study type Interventional
Source Heinrich-Heine University, Duesseldorf
Contact Michael Schädel-Höpfner, MD
Phone +49 211 8104405
Email schaedel@uni-duesseldorf.de
Status Recruiting
Phase N/A
Start date November 2005
View Details
See also
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Completed NCT03297047 - Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children N/A
Completed NCT03496337 - Is AMPS a Responsive Tool for Assessing Change in ADL-abilities After Finger or Hand Surgery
Completed NCT00274378 - Allomatrix Injectable Putty in Distal Radius Fractures Phase 4
Not yet recruiting NCT04930718 - Thumb and Wrist Proprioception Exercises. N/A
Completed NCT04062110 - Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures N/A
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Completed NCT03423043 - Low Dose CT Distal Radius Fractures
Completed NCT03438864 - Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture N/A
Completed NCT02670629 - Management of Distal Radius Fractures in Children Younger Than 11 Years Old. N/A
Completed NCT00989222 - Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? N/A
Active, not recruiting NCT06067074 - Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture N/A
Completed NCT02348437 - Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT. N/A
Completed NCT02630290 - Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial) Phase 4
Completed NCT01262807 - Reducing Range of Motion Deficits Post Radial Fracture N/A
Completed NCT03570905 - Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures N/A
Completed NCT02533557 - Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block N/A