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

NCT ID: NCT00828685

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

Wrist Fractures

Study Groups

Operative (CRPP)

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

Group Type: ACTIVE_COMPARATOR

CRPP

Intervention Type: PROCEDURE

Closed reduction, percutaneous pinning

Operative (ORIF)

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

Group Type: ACTIVE_COMPARATOR

ORIF

Intervention Type: PROCEDURE

Open reduction, internal fixation

Interventions

CRPP

Closed reduction, percutaneous pinning

Intervention Type: PROCEDURE

ORIF

Open reduction, internal fixation

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tamara Rozental

Associate Professor of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara D Rozental, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19651939 (View on PubMed)

Other Identifiers

2005P000301

Identifier Type: -

Identifier Source: org_study_id