Fixation of Unstable Distal Radius Fractures - Full Text View

Sponsors and Collaborators:	Wake Forest University Wright Medical Technology
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00654615

Purpose

Wrist fractures are the most common type of fractures that occur in the shoulder, arm, and hand. Approximately 250,000 to 300,000 wrist fractures occur in the United States each year. Although some wrist fractures can be treated using casts, many other fractures must be treated with surgery. The surgery involves using metal plates and screws to put the broken pieces of bone together so that they can heal. The purpose of this study is to compare two specific types of surgery that are used to treat broken wrists. One type uses pieces of metal that are placed on the outside of the broken pieces of bone that are screwed in place while the broken bones heal. The other type of surgery involves placing a piece of metal inside the bone marrow to hold the broken pieces of bone together as they heal. Individuals with broken wrists who participate in this study will be randomly assigned to receive one of the two types of surgical treatment. Both surgical treatments are approved and are not experimental. Study participants will be followed closely after surgery to determine the time required for them to return to their usual daily activities involving the use of their arms and hands. Although both groups of study participants are expected to experience the same outcomes at one year, those participants that receive the device placed inside the bone marrow may return to their normal functional activities earlier than the ones treated with the plate placed on the outside of the bone. Study participants and their surgeons will complete data sheets and questionnaires that will document their progress following treatment of their wrist fractures.

Condition	Intervention
Distal Radius Fractures	Device: Micronail Procedure: Volar Plate Fixation

MedlinePlus related topics: Fractures

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Fixation of Unstable Metaphyseal Distal Radius Fractures: A Randomized, Controlled Trial

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

Michigan Hand Outcomes Questionnaire [ Time Frame: one week post-surgery compared to six weeks post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disabilities of the Arm, Shoulder, and Hand Questionnaire [ Time Frame: one week post-surgery compared with six weeks post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	May 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intramedullary Radius Fixation (Micronail) - Group 1	Device: Micronail After adequate anesthesia is obtained and the patient is prepared for surgery, distraction will be applied to the fracture site and preliminary reduction of the distal radius fracture performed under fluoroscopic guidance. A pin will be inserted to maintain the fracture reduction, then the Micronail will be inserted inside the radius. The metaphyseal defect created by the fracture will be filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns will be performed to achieve acceptable reduction of the fracture. Radiographic parameters will be used to evaluate the results of the surgical management with intramedullary nailing.
2: Active Comparator Volar Plate Fixation - Group 2	Procedure: Volar Plate Fixation After adequate anesthesia is obtained, longitudinal traction of the wrist will be applied using either finger traps or a simple pin fixator. Based on the type of fracture pattern, the fragments will be reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. An arthrotomy may be performed to verify by visual inspection that the fracture fragments have been reduced. The plates will be contoured to fit the patient's boney contours as needed. Allograft or autograft material will be placed in the fracture repair site as necessary. Radiographic landmarks will be evaluated. Care will be taken to ensure that the plates are covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision will be closed and a removable splint applied.

Arms

Assigned Interventions

1: Active Comparator

Intramedullary Radius Fixation (Micronail) - Group 1

Device: Micronail

After adequate anesthesia is obtained and the patient is prepared for surgery, distraction will be applied to the fracture site and preliminary reduction of the distal radius fracture performed under fluoroscopic guidance. A pin will be inserted to maintain the fracture reduction, then the Micronail will be inserted inside the radius. The metaphyseal defect created by the fracture will be filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns will be performed to achieve acceptable reduction of the fracture. Radiographic parameters will be used to evaluate the results of the surgical management with intramedullary nailing.

2: Active Comparator

Volar Plate Fixation - Group 2

Procedure: Volar Plate Fixation

After adequate anesthesia is obtained, longitudinal traction of the wrist will be applied using either finger traps or a simple pin fixator. Based on the type of fracture pattern, the fragments will be reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. An arthrotomy may be performed to verify by visual inspection that the fracture fragments have been reduced. The plates will be contoured to fit the patient's boney contours as needed. Allograft or autograft material will be placed in the fracture repair site as necessary. Radiographic landmarks will be evaluated. Care will be taken to ensure that the plates are covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision will be closed and a removable splint applied.

Detailed Description:

INTRODUCTION: Fractures of the distal radius are the most common upper extremity fractures, accounting for approximately 250,000 to 300,000 injuries in the United States annually. The goals of treatment for patients with distal radius fractures are restoration of wrist anatomy, return of normal pain-free hand and wrist range of motion, and early return to normal activities of daily living. Management of distal radius fractures is dictated by the fracture pattern, the degree of displacement of the bone fragments, whether or not the fracture involves the joint, the presence of other bodily injuries, and the patient's pre-injury activity level and physical demands.

Unstable distal radius fractures require surgical fixation of the broken bone because closed reduction (nonsurgical manipulation of the fractured bones and casting) often is not sufficient to maintain fracture reduction and promote bone healing. Operative management of distal radius fractures has been studied extensively and has evolved over the past decade.

STUDY HYPOTHESIS: There are no published prospective, randomized trials comparing open reduction using volar plating to intramedullary fixation for the management of displaced unstable, metaphyseal distal radius fractures. The study hypothesis is that the outcomes of treatment of distal radius fractures using an intramedullary radius fixation system (Micronail®) will result in the earlier return of wrist range of motion, earlier functional recovery, and improvements in health-related quality of life equal to or superior to the outcomes of volar plate fixation.

SPECIFIC AIMS: The specific aim of this randomized, controlled clinical trial is to compare an intramedullary radius fixation system (Micronail®) to a volar locking plate technique for the management of displaced, unstable, metaphyseal distal radius fractures. Both functional and health-related quality of life outcomes of the study participants will be documented during the trial. In addition, radiographic information will be collected to compare the radiographic evidence of fracture healing in the two treatment groups.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients eligible for participation in this study will include skeletally mature individuals between the ages of 18 through 80 who have sustained closed, displaced, unstable, metaphyseal fractures of the distal radius requiring surgical fixation.

Exclusion Criteria:

Patients ineligible for study participation will include:
- patients with multitrauma who must be treated in the ICU for long periods of time
- patients with open wrist fractures,
- patients who are skeletally immature,
- patients with concomitant scaphoid fractures or other hand injuries that impact functional recovery,
- patients with bilateral arm fractures or comminuted intraarticular distal radius fractures,
- patients who have sustained previous wrist injury of the affected arm,
- signs of rheumatoid arthritis, osteoarthritis, or polyarthritis, and
- patients with physical or mental issues that make obtaining informed consent impossible.
Any comorbid health conditions of the study participants (e.g. high blood pressure, COPD) will be documented.
Patients who are interested in participating in this study will be asked to provide informed consent prior to their entry into the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654615

Contacts

Contact: Zhongyu Li, MD	336-716-9351	zli@wfubmc.edu
Contact: Beth P. Smith, PhD	336-716-3950	bpsmith@wfubmc.edu

Locations

United States, North Carolina
Wake Forest University Health Sciences - CompRehab
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Wright Medical Technology

Investigators

Principal Investigator:

Zhongyu Li, MD, PhD

Assistant Professor

More Information

Responsible Party:	Wake Forest University Health Sciences ( Zhongyu Li, MD, PhD, Assistant Professor )
Study ID Numbers:	IRB00003715, GTS#32801
Study First Received:	April 2, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00654615
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

unstable metaphyseal distal radius fractures
randomized controlled trial
surgical fixation
volar plate
intramedullary distal radius fixation system

Study placed in the following topic categories:

Fractures, Bone
Benzocaine
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009