Clinical trial NCT00654615: Fixation of Unstable Distal Radius Fractures
Official title: The Fixation of Unstable Metaphyseal Distal Radius Fractures: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Keywords: unstable metaphyseal distal radius fractures
randomized controlled trial
surgical fixation
volar plate
intramedullary distal radius fixation system
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Stryker Trauma and Extremities
First posted: 2008-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Average Difference Between Michigan Hand Outcomes Questionnaire Scores
timeFrame: two week post-surgery compared to six weeks post-surgery
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
timeFrame: two week post-surgery compared with six weeks post-surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences - CompRehab
state: North Carolina
Study officials:
affiliation: Assistant Professor
name: Zhongyu Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: