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Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures

Primary Purpose

Wrist Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRPP
ORIF
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Wrist Fractures focused on measuring Return to Work, CRPP, ORIF, Distal Radius

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or greater
  • Patient functions independently
  • Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets.
  • Isolated injury (no other injuries).
  • One of the following criteria:

Substantial initial displacement

  • Greater than 20 degrees dorsal angulation of the articular surface on the lateral view.
  • Greater than 100% loss of apposition.
  • Greater than 5 millimeters of shortening by ulnar variance on the posteroanterior radiograph.
  • Greater than 2 millimeters articular incongruity (step or gap).
  • Both dorsal and volar comminution. Inadequate initial manipulative reduction
  • Greater than 5 degrees of dorsal angulation of the articular surface on the lateral radiograph.
  • Greater than 3 millimeters of radial shortening by ulnar variance on the posteroanterior radiograph.
  • Greater than 2 millimeters articular incongruity.
  • Bayonett apposition of the volar cortex.
  • Less than 15 degrees of ulnarward inclination of the articular surface in the posteroanterior radiograph. Loss of reduction within 3 weeks of injury.
  • Any of the following changes in alignment from the initial post- reduction radiographs qualify:

    • 5 degrees or greater loss of palmar tilt of the articular surface on the lateral radiograph.
    • 2 millimeters or greater loss of radial height by ulnar variance on the posteroanterior radiograph.
    • 5 degrees or greater loss of ulnarward inclination of the articular surface of the distal radius on the posteroanteriorradiograph.
    • 2 millimeters or greater articular incongruity.

Exclusion Criteria:

  • More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets).
  • Volarly displaced fractures.
  • Infirm patients.
  • Patients that rely on others for basic functional activities.
  • Open fractures
  • Fractures associated with neurovascular injury.
  • Fractures associated with major head, neurological, or visceral injuries that will inhibit the ability to participate in a structured exercise program.
  • Associated musculoskeletal injuries to the same arm.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Operative (CRPP)

Operative (ORIF)

Arm Description

If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized.

If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized

Outcomes

Primary Outcome Measures

Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.

Secondary Outcome Measures

Range of motion measured in wrist and a scored DASH questionnaire

Full Information

First Posted
January 13, 2009
Last Updated
February 3, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00828685
Brief Title
Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures
Official Title
Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius. Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are better in patients treated with open reduction, internal fixation (ORIF) than in patients treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients treated with ORIF return to work at faster rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fractures
Keywords
Return to Work, CRPP, ORIF, Distal Radius

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Operative (CRPP)
Arm Type
Active Comparator
Arm Description
If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized.
Arm Title
Operative (ORIF)
Arm Type
Active Comparator
Arm Description
If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized
Intervention Type
Procedure
Intervention Name(s)
CRPP
Intervention Description
Closed reduction, percutaneous pinning
Intervention Type
Procedure
Intervention Name(s)
ORIF
Intervention Description
Open reduction, internal fixation
Primary Outcome Measure Information:
Title
Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
Time Frame
3 months post surgery
Secondary Outcome Measure Information:
Title
Range of motion measured in wrist and a scored DASH questionnaire
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or greater Patient functions independently Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets. Isolated injury (no other injuries). One of the following criteria: Substantial initial displacement Greater than 20 degrees dorsal angulation of the articular surface on the lateral view. Greater than 100% loss of apposition. Greater than 5 millimeters of shortening by ulnar variance on the posteroanterior radiograph. Greater than 2 millimeters articular incongruity (step or gap). Both dorsal and volar comminution. Inadequate initial manipulative reduction Greater than 5 degrees of dorsal angulation of the articular surface on the lateral radiograph. Greater than 3 millimeters of radial shortening by ulnar variance on the posteroanterior radiograph. Greater than 2 millimeters articular incongruity. Bayonett apposition of the volar cortex. Less than 15 degrees of ulnarward inclination of the articular surface in the posteroanterior radiograph. Loss of reduction within 3 weeks of injury. Any of the following changes in alignment from the initial post- reduction radiographs qualify: 5 degrees or greater loss of palmar tilt of the articular surface on the lateral radiograph. 2 millimeters or greater loss of radial height by ulnar variance on the posteroanterior radiograph. 5 degrees or greater loss of ulnarward inclination of the articular surface of the distal radius on the posteroanteriorradiograph. 2 millimeters or greater articular incongruity. Exclusion Criteria: More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets). Volarly displaced fractures. Infirm patients. Patients that rely on others for basic functional activities. Open fractures Fractures associated with neurovascular injury. Fractures associated with major head, neurological, or visceral injuries that will inhibit the ability to participate in a structured exercise program. Associated musculoskeletal injuries to the same arm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara D Rozental, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19651939
Citation
Rozental TD, Blazar PE, Franko OI, Chacko AT, Earp BE, Day CS. Functional outcomes for unstable distal radial fractures treated with open reduction and internal fixation or closed reduction and percutaneous fixation. A prospective randomized trial. J Bone Joint Surg Am. 2009 Aug;91(8):1837-46. doi: 10.2106/JBJS.H.01478.
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Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures

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