Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
NCT ID: NCT00271726
Last Updated: 2007-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2005-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Osteosynthesis with palmar locking plate
Osteosynthesis with external fixator
Osteosynthesis with Kirschner wires
Eligibility Criteria
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Inclusion Criteria
* Age 65 years or older
* Patient agreed with and signed the "informed consent" form
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Philipps University Marburg
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Principal Investigators
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Michael Schädel-Höpfner, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
Locations
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Department of Trauma and Hand Surgery, University Hospital
Düsseldorf, , Germany
Countries
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Central Contacts
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Facility Contacts
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Michael Schädel-Höpfner, MD
Role: primary
Other Identifiers
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OTEC Pilot 1 KKS MR
Identifier Type: -
Identifier Source: org_study_id