Fixation of Unstable Distal Radius Fractures

NCT00654615 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00003715GTS#32801
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fractures

Keywords

unstable metaphyseal distal radius fractures; randomized controlled trial; surgical fixation; volar plate; intramedullary distal radius fixation system

Outcome Measures

Primary Outcomes (1)

• Average Difference Between Michigan Hand Outcomes Questionnaire Scores

  Developed at the University of Michigan Department of Plastic Surgery to evaluate outcomes and function in patients who sustain upper extremity injuries. This will be done one week post-surgery compared to six weeks post-surgery comparing the two groups. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics, satisfaction. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. The overall MHQ score ranged between 0-100. Higher scores indicate better hand performance.

  two week post-surgery compared to six weeks post-surgery

Secondary Outcomes (1)

• Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

  two week post-surgery compared with six weeks post-surgery

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Device: Intramedullary Radius Fixation (Micronail)

2

ACTIVE COMPARATOR

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.

Procedure: Volar Plate Fixation

Interventions

Intramedullary Radius Fixation (Micronail) 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.

1

Volar Plate Fixation 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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Wake Forest University Health Sciences - CompRehab

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Zhongyu Li, MD, PhD, Professor - Department of Orthopaedic Surgery
• Organization: Wake Forest University Health Sciences

zli@wakehealth.edu

336-716-9520

Study Officials

• Zhongyu Li, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was a prospective clinical trial comparing two different types of hardware to fix a specific type of distal radius fracture.

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 8, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 11, 2018
• Results First Posted: November 13, 2017

Record last verified: 2018-08

Locations

US (1)