Distal Radius Fracture - Treatment Comparison

NCT01883063 | Terminated DMC

• 1 other identifier: WRx-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Minimally Displaced Intra-articular Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Composite Functional Outcomes Over Time

  Data will be collected at 2, 6, 12, 26, 52 weeks

Study Arms (2)

WRx™ Intramedullary Nail

EXPERIMENTAL

Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture.

Device: Surgical Treatment

Non surgical treatment (Cast)

ACTIVE COMPARATOR

Patients in this arm of the study will be treated with a cast for their wrist fracture.

Device: Non surgical Treatment (Cast or splint)

Interventions

Surgical Treatment DEVICE

Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail

WRx™ Intramedullary Nail

Non surgical Treatment (Cast or splint) DEVICE

Patients will be treated for distal radius fractures non surgically with a cast or splint

Non surgical treatment (Cast)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonoma Orthopedic Products, Inc.: lead

Study Sites (3)

Cadence Health

Winfield, Illinois, 60190, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

John Peter Smith Hospital

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative; Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 21, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (3)