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.

Study Overview

• Status: Completed
• Conditions: Wrist Fractures
• Intervention / Treatment: Procedure: CRPP; Procedure: ORIF

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Operative (CRPP); If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized.	Procedure: CRPP; Closed reduction, percutaneous pinning
Active Comparator: Operative (ORIF); If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized	Procedure: ORIF; Open reduction, internal fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.	3 months post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Range of motion measured in wrist and a scored DASH questionnaire	1 year after surgery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Tamara D Rozental, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

General 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.

Study record dates

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Distal Radius; Return to Work; CRPP; ORIF
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2005P000301