Fixation of Unstable Distal Radius Fractures
Condition: Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Intramedullary Radius Fixation (Micronail); Volar Plate Fixation
Intervention type(s): Device; Procedure
Intervention description(s): After adequate anesthesia was obtained and the patient was prepared for surgery, distraction was applied to the fracture site and preliminary reduction of the distal radius fracture was performed under fluoroscopic guidance. A pin was inserted to maintain the fracture reduction, then the Micronail was inserted inside the radius. The metaphyseal defect created by the fracture was filled using allograft or autograft bone material. Limited incisions at either the radial or ulnar columns was performed to achieve acceptable reduction of the fracture. Radiographic parameters were used to evaluate the results of the surgical management with intramedullary nailing.; After adequate anesthesia, longitudinal traction of the wrist was applied. Based on the fracture pattern, fragments were reduced and stabilized using either one 2.4mm titanium pre-contoured locking plate or a combination of locking plates. Arthrotomy was performed to verify that the fracture fragments were reduced. Plates were contoured to fit boney contours as needed. Allograft or autograft was placed in the fracture repair site as necessary. Radiographic landmarks were evaluated. Care was taken to ensure that plates were covered with periosteum or retinaculum to reduce the incidence of possible soft tissue irritation caused by the plate on the bone. The skin incision was closed; a removable splint applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a prospective clinical trial comparing two different types of hardware to fix a specific type of distal radius fracture.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unstable metaphyseal distal radius fractures; randomized controlled trial; surgical fixation; volar plate; intramedullary distal radius fixation system