Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00828685

Purpose

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.

Condition	Intervention
Wrist Fractures	Procedure: CRPP Procedure: ORIF

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Wrist range of motion measurement. As well as recorded score from the DASH questionnaire. [ Time Frame: 3 months post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Range of motion measured in wrist and a scored DASH questionnaire [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Operative (CRPP): Active Comparator If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized.	Procedure: CRPP Closed reduction, percutaneous pinning
Operative (ORIF): Active Comparator If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized	Procedure: ORIF Open reduction, internal fixation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828685

Locations

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

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Tamara D Rozental, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Study ID Numbers:	2005P000301
Study First Received:	January 13, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828685
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Return to Work
CRPP
ORIF
Distal Radius

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Radius Fractures

ClinicalTrials.gov processed this record on February 11, 2009