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Distal Radius Fracture - Treatment Comparison

Primary Purpose

Minimally Displaced Intra-articular Distal Radius Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical Treatment
Non surgical Treatment (Cast or splint)
Sponsored by
Sonoma Orthopedic Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minimally Displaced Intra-articular Distal Radius Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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.

Sites / Locations

  • Cadence Health
  • University of Missouri
  • John Peter Smith Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WRx™ Intramedullary Nail

Non surgical treatment (Cast)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Composite Patient Outcomes Over Time
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.

Secondary Outcome Measures

Change in Composite Functional Outcomes Over Time
Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.

Full Information

First Posted
June 14, 2013
Last Updated
April 12, 2015
Sponsor
Sonoma Orthopedic Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01883063
Brief Title
Distal Radius Fracture - Treatment Comparison
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Low Enrollment
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonoma Orthopedic Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimally Displaced Intra-articular Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WRx™ Intramedullary Nail
Arm Type
Experimental
Arm Description
Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture.
Arm Title
Non surgical treatment (Cast)
Arm Type
Active Comparator
Arm Description
Patients in this arm of the study will be treated with a cast for their wrist fracture.
Intervention Type
Device
Intervention Name(s)
Surgical Treatment
Intervention Description
Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
Intervention Type
Device
Intervention Name(s)
Non surgical Treatment (Cast or splint)
Intervention Description
Patients will be treated for distal radius fractures non surgically with a cast or splint
Primary Outcome Measure Information:
Title
Change in Composite Patient Outcomes Over Time
Description
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
Time Frame
Data will be collected at 2, 6, 12, 26, 52 weeks
Secondary Outcome Measure Information:
Title
Change in Composite Functional Outcomes Over Time
Description
Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.
Time Frame
Data will be collected at 2, 6, 12, 26, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Cadence Health
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
John Peter Smith Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Distal Radius Fracture - Treatment Comparison

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