Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00654615
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase N/A
Start date May 2008
Completion date September 2013

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06453447 - Prednisone for CRPS in Distal Radius Fracture N/A
Recruiting NCT06136286 - ORIF Distal Radius Blood Flow Restriction Therapy N/A
Not yet recruiting NCT06078371 - Opioid-Free Pain Treatment in Trauma Patients N/A
Not yet recruiting NCT05902442 - A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures. N/A
Withdrawn NCT00788190 - Treatment of Distal Radius Fractures in Elderly Patients N/A
Completed NCT02990052 - Conservative Treatment vs. Volar Plating of Distal Radius Fractures N/A
Completed NCT06343467 - Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? N/A
Recruiting NCT06046404 - Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department N/A
Not yet recruiting NCT06251206 - Impact of Early ADL Education on Outcomes Post DRF ORIF Phase 1
Completed NCT01937624 - Pediatric Distal Radius US Study
Completed NCT01007565 - Postoperative Pain After Volar Plating for Distal Radius Fractures Phase 2
Terminated NCT01859468 - A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures Phase 1/Phase 2
Completed NCT01103297 - 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Phase 4
Completed NCT05942950 - Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
Completed NCT06215872 - Effectiveness of Structured Myofacial Chain Exercises After Distal Radius Fracture N/A
Suspended NCT01693094 - A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome N/A
Not yet recruiting NCT06235957 - Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures N/A
Recruiting NCT06019585 - Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures N/A
Terminated NCT02802774 - Immobilization of Postoperative Distal Radius Fractures N/A
Enrolling by invitation NCT05086224 - Hematoma Block Versus Bier Block for Closed Fracture Reduction Early Phase 1