Wrist Extension Dynasplint (WED) Distal Radius Fracture

NCT ID: NCT01589627

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.

Conditions

Distal Radius Fracture; Wrist Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental

Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint

Group Type: EXPERIMENTAL

Wrist Extension Dynasplint

Intervention Type: DEVICE

Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.

Control

Patients will receive standard of care physical therapy and NSAIDS

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wrist Extension Dynasplint

Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion Criteria

• Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
• Radial nerve entrapment
• Arthrodesis
• Traumatic dislocation of the distal ulna

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dynasplint Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy Berner, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Centers for Orthopaedic Surgery and Sports Medicine

Other Identifiers

2009.003

Identifier Type: -

Identifier Source: org_study_id