CClinicalTrials.gg
CompletedNCT00828685Updated Feb 7, 2017

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

An interventional study of CRPP and ORIF in Wrist Fractures, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Wrist Fractures

Keywords

  • Return to Work
  • CRPP
  • ORIF
  • Distal Radius
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In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

Browse Fractures, Bone studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable

Study arms

  • Active comparator
    Operative (CRPP)

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

    Procedure: CRPP

  • Active comparator
    Operative (ORIF)

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

    Procedure: ORIF

Interventions

  • ProcedureCRPP

    Closed reduction, percutaneous pinning

  • ProcedureORIF

    Open reduction, internal fixation

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What researchers measure

Primary outcomes

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

    Time frame: 3 months post surgery

Secondary outcomes

  1. Range of motion measured in wrist and a scored DASH questionnaire

    Time frame: 1 year after surgery

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Publications

  • 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. PubMed 19651939 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00828685
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Tamara Rozental (Associate Professor of Orthopedic Surgery, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jan 26, 2009
Last update
Feb 7, 2017

Study contacts

Tamara D Rozental, MD
principal investigator · Beth Israel Deaconess Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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