Clinical trial NCT00828685: Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures
Official title: Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Fractures
Keywords: Return to Work
CRPP
ORIF
Distal Radius
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2009-01-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Range of motion measured in wrist and a scored DASH questionnaire
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Tamara D Rozental, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.