Distal Radius Fracture - Treatment Comparison

NCT ID: NCT01883063

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WRx™ Intramedullary Nail

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

Group Type: EXPERIMENTAL

Surgical Treatment

Intervention Type: DEVICE

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

Non surgical treatment (Cast)

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

Group Type: ACTIVE_COMPARATOR

Non surgical Treatment (Cast or splint)

Intervention Type: DEVICE

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

Interventions

Surgical Treatment

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

Intervention Type: DEVICE

Non surgical Treatment (Cast or splint)

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sonoma Orthopedic Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cadence Health

Winfield, Illinois, United States

University of Missouri

Columbia, Missouri, United States

John Peter Smith Hospital

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

WRx-001

Identifier Type: -

Identifier Source: org_study_id