Distal Radius Fracture - Treatment Comparison

Not Applicable

Terminated

• Conditions: Minimally Displaced Intra-articular Distal Radius Fracture
• Interventions: Device: Non surgical Treatment (Cast or splint); Device: Surgical Treatment

• Registration Number: NCT01883063
• Lead Sponsor: Sonoma Orthopedic Products, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Study Start: 2013-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-12
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non surgical treatment (Cast)	Non surgical Treatment (Cast or splint)	Patients in this arm of the study will be treated with a cast for their wrist fracture.
WRx™ Intramedullary Nail	Surgical Treatment	Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture.

Primary Outcome Measures

Name	Time	Method
Change in Composite Patient Outcomes Over Time	Data will be collected at 2, 6, 12, 26, 52 weeks	Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change in Composite Functional Outcomes Over Time	Data will be collected at 2, 6, 12, 26, 52 weeks	Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.

Trial Locations

Locations (3)

John Peter Smith Hospital; 🇺🇸 Fort Worth, Texas, United States

Cadence Health; 🇺🇸 Winfield, Illinois, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States