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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colles' Fracture, Radius Fractures

Intervention / Treatment
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* Procedure: Osteosynthesis with palmar locking plate
* Procedure: Osteosynthesis with external fixator
* Procedure: Osteosynthesis with Kirschner wires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3) Age 65 years or older Patient agreed with and signed the informed consent form Exclusion Criteria: Fractures older than 7 days (more than 1 week between injury and treatment) Other injuries of the hand Other relevant injuries of the upper extremities Open fracture Patients with one hand missing Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis Previous skeletal injury or severe soft tissue injury of the arm History of drug or alcohol abuse Patients unlikely to cooperate or attend all scheduled visits Patients who have participated in any other device or drug clinical trial within the previous month Patients with legal incompetence

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Osteosynthesis with palmar locking plate|nan|
|Procedure: Osteosynthesis with external fixator|nan|
|Procedure: Osteosynthesis with Kirschner wires|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status measured by DASH questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 
| Range of motion (ROM) |  |  | 
| Grip strength |  |  | 
| Radiological parameters |  |  | 
| Feasibility |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radius fracture, extraarticular Colles fracture