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Distal Radius Fracture - Treatment Comparison

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ClinicalTrials.gov Identifier: NCT01883063
Recruitment Status : Terminated (Low Enrollment)
First Posted : June 21, 2013
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sonoma Orthopedic Products, Inc.

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.

Condition or disease Intervention/treatment Phase
Minimally Displaced Intra-articular Distal Radius Fracture Device: Surgical Treatment Device: Non surgical Treatment (Cast or splint) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883063


Locations
United States, Illinois
Cadence Health
Winfield, Illinois, United States, 60190
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
United States, Texas
John Peter Smith Hospital
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
Sonoma Orthopedic Products, Inc.

Responsible Party: Sonoma Orthopedic Products, Inc.
ClinicalTrials.gov Identifier: NCT01883063     History of Changes
Other Study ID Numbers: WRx-001
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries