Distal Radius Fracture - Treatment Comparison

PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Winfield, Illinois, United States, 60190
      • Cadence Health
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri
  • Texas
    • Fort Worth, Texas, United States, 76107
      • John Peter Smith Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WRx™ Intramedullary Nail; Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture.	Device: Surgical Treatment; Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
Active Comparator: Non surgical treatment (Cast); Patients in this arm of the study will be treated with a cast for their wrist fracture.	Device: Non surgical Treatment (Cast or splint); Patients will be treated for distal radius fractures non surgically with a cast or splint

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sonoma Orthopedic Products, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 12, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: WRx-001