NCT00828685

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

First QC Date

January 13, 2009

Last Update Submit

February 3, 2017

Conditions

Wrist Fractures

Keywords

Return to WorkCRPPORIFDistal Radius

Outcome Measures

Primary Outcomes (1)

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

    3 months post surgery

Secondary Outcomes (1)

  • Range of motion measured in wrist and a scored DASH questionnaire

    1 year after surgery

Study Arms (2)

Operative (CRPP)

ACTIVE COMPARATOR

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

Procedure: CRPP

Operative (ORIF)

ACTIVE COMPARATOR

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

Procedure: ORIF

Interventions

CRPPPROCEDURE

Closed reduction, percutaneous pinning

Operative (CRPP)
ORIFPROCEDURE

Open reduction, internal fixation

Operative (ORIF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 19651939RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Tamara D Rozental, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedic Surgery

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 26, 2009

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)