Status:
TERMINATED
Distal Radius Fracture - Treatment Comparison
Lead Sponsor:
Sonoma Orthopedic Products, Inc.
Conditions:
Minimally Displaced Intra-articular Distal Radius Fracture
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint o...
Eligibility Criteria
Inclusion
- Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture
- Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture
- Must be treated within the first 14 days of injury,
- Male or female greater than or equal to 65 years of age.
- Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
- Ability to understand and provide written authorization for use and disclosure of personal health information
- Fracture that can be treated closed with or without closed reduction
Exclusion
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open fracture
- Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- Unstable distal radioulnar joint after fracture fixation
- Fractures where the transverse fracture line is less than 10mm from the distal radius joint surface
- Artery or Nerve injury secondary to fracture
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Currently on worker's compensation
- Rheumatoid arthritis or other inflammatory arthropathies.
- History of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01883063
Start Date
July 1 2013
End Date
December 1 2014
Last Update
April 14 2015
Active Locations (3)
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1
Cadence Health
Winfield, Illinois, United States, 60190
2
University of Missouri
Columbia, Missouri, United States, 65211
3
John Peter Smith Hospital
Fort Worth, Texas, United States, 76107