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

Wrist Fractures Clinical Trial

Official title:

Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828685
• Other study ID #: 2005P000301
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: February 3, 2017

Study information

• Verified date: February 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Wrist Fractures

Intervention

Procedure:
• CRPP
Closed reduction, percutaneous pinning
• ORIF
Open reduction, internal fixation

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.		3 months post surgery
Secondary	Range of motion measured in wrist and a scored DASH questionnaire		1 year after surgery