Clinical trial NCT01883063: Distal Radius Fracture - Treatment Comparison
Official title: PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Minimally Displaced Intra-articular Distal Radius Fracture
Lead sponsor: Sonoma Orthopedic Products, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Composite Patient Outcomes Over Time
timeFrame: Data will be collected at 2, 6, 12, 26, 52 weeks
Secondary outcomes:
measure: Change in Composite Functional Outcomes Over Time
timeFrame: Data will be collected at 2, 6, 12, 26, 52 weeks
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Cadence Health
state: Illinois
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
Study officials:
References: