Fixation of Unstable Distal Radius Fractures
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Fixation of Unstable Metaphyseal Distal Radius Fractures: A Randomized, Controlled Trial|
- Michigan Hand Outcomes Questionnaire [ Time Frame: one week post-surgery compared to six weeks post-surgery ] [ Designated as safety issue: No ]
- 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 ]
|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)|
Active Comparator: 1
Intramedullary Radius Fixation (Micronail) - Group 1
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.
Other Name: Intramedullary Radius Fixation
Active Comparator: 2
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654615
|Contact: Zhongyu Li, MDemail@example.com|
|Contact: Beth P. Smith, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University Health Sciences - CompRehab||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Zhongyu Li, MD 336-716-9351 email@example.com|
|Contact: Beth P. Smith, PhD 336-716-3950 firstname.lastname@example.org|
|Principal Investigator: Zhongyu Li, MD|
|Principal Investigator:||Zhongyu Li, MD, PhD||Assistant Professor|