Fixation of Unstable Distal Radius Fractures

NCT ID: NCT00654615

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-09-30

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.

Conditions

Distal Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Intramedullary Radius Fixation (Micronail) - Group 1

A new device was developed to provide intramedullary distal radius fracture fixation. This new device allows the placement of the orthopaedic hardware inside the medullary canal of the radius.

Group Type: ACTIVE_COMPARATOR

Intramedullary Radius Fixation (Micronail)

Intervention Type: DEVICE

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.

2

Volar Plate Fixation - Group 2

Volar locking plates provide rigid external fixation and are placed on the outside of the radius. Volar plates are placed directly on the distal radius using a metal plate contoured to the shape of the distal radius.

Group Type: ACTIVE_COMPARATOR

Volar Plate Fixation

Intervention Type: PROCEDURE

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.

Interventions

Intramedullary Radius Fixation (Micronail)

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.

Intervention Type: DEVICE

Volar Plate Fixation

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhongyu Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Wake Forest University Health Sciences - CompRehab

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

GTS#32801

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00003715

Identifier Type: -

Identifier Source: org_study_id