Status:
COMPLETED
Comparison of Two Volar Plating Systems for Distal Radius Fractures
Lead Sponsor:
Medical University of Vienna
Conditions:
Distal Radius Fracture
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a pro...
Detailed Description
This study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures. Patients meeting the inclusion cr...
Eligibility Criteria
Inclusion
- " Distal radius fracture, Type A2, A3, B1, B2, B3, C1, C2 (according to AO Müller classification3) " Patient age between 18 and 75 years " Closed fracture or I° open fractures (according to Gustilo-Anderson classification6) " Agreement of patient to participate and written informed consent
Exclusion
- " Polytraumatized patients " Severe systemic disorder (ASA 3) " New and/or preexisting fracture/Injury of contralateral forearm " II° and III° open fractures (according to Gustilo-Anderson classification6) " Associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " Non-compliance to postoperative protocol (e.g. physiotherapy) " Delayed definitive surgical treatment of more than 14 days after injury " Change from temporary procedure (e.g. Fixateur externe) " Complex regional pain syndrome (CRPS, M.Sudeck) " Loss to follow-up
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03474445
Start Date
March 1 2017
End Date
February 28 2022
Last Update
April 6 2022
Active Locations (1)
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1
Medical Universtiy of Vienna
Vienna, Austria, A-1090