Fixation of Unstable Distal Radius Fractures
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/13/2018 |
| Start Date: | May 2008 |
| End Date: | September 2013 |
The Fixation of Unstable Metaphyseal Distal Radius Fractures: A Randomized, Controlled Trial
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.
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.
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.
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.
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.
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