Distal Radius Fracture - Treatment Comparison

Sonoma Orthopedics

Status: Terminated

Conditions: Minimally Displaced Intra-articular Distal Radius Fracture

Treatments: Device: Surgical Treatment; Device: Non surgical Treatment (Cast or splint)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01883063

WRx-001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

WRx™ Intramedullary Nail

Experimental group

Description:

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

Treatment:

Device: Surgical Treatment

Non surgical treatment (Cast)

Active Comparator group

Description:

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

Treatment:

Device: Non surgical Treatment (Cast or splint)