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

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00828685
First received: January 13, 2009
Last updated: January 23, 2009
Last verified: January 2009

January 13, 2009
January 23, 2009
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Wrist range of motion measurement. As well as recorded score from the DASH questionnaire. [ Time Frame: 3 months post surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00828685 on ClinicalTrials.gov Archive Site
Range of motion measured in wrist and a scored DASH questionnaire [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
Same as current
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Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures
Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial

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.

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Interventional
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Wrist Fractures
  • Procedure: CRPP
    Closed reduction, percutaneous pinning
  • Procedure: ORIF
    Open reduction, internal fixation
  • Active Comparator: Operative (CRPP)
    If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized.
    Intervention: Procedure: CRPP
  • Active Comparator: Operative (ORIF)
    If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized
    Intervention: Procedure: ORIF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828685
2005P000301
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Beth Israel Deaconess Medical Center
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Principal Investigator: Tamara D Rozental, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP