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Fixation of Unstable Distal Radius Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654615
First Posted: April 8, 2008
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Zhongyu Li, Wake Forest University Health Sciences
Results First Submitted: April 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Distal Radius Fractures
Interventions: Device: Intramedullary Radius Fixation (Micronail)
Procedure: Volar Plate Fixation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intramedullary Radius Fixation (Micronail) - Group 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.

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.

Volar Plate Fixation - Group 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.

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.


Participant Flow:   Overall Study
    Intramedullary Radius Fixation (Micronail) - Group 1   Volar Plate Fixation - Group 2
STARTED   30   30 
COMPLETED   22   23 
NOT COMPLETED   8   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intramedullary Radius Fixation (Micronail) - Group 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.

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.

Volar Plate Fixation - Group 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.

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.

Total Total of all reporting groups

Baseline Measures
   Intramedullary Radius Fixation (Micronail) - Group 1   Volar Plate Fixation - Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      24  80.0%      23  76.7%      47  78.3% 
>=65 years      6  20.0%      7  23.3%      13  21.7% 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 55  (14)   55  (16)   55  (15) 
[1] Participants between the ages of 18 and 80 were enrolled.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  83.3%      19  63.3%      44  73.3% 
Male      5  16.7%      11  36.7%      16  26.7% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Difference Between Michigan Hand Outcomes Questionnaire Scores   [ Time Frame: two week post-surgery compared to six weeks post-surgery ]

2.  Secondary:   Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)   [ Time Frame: two week post-surgery compared with six weeks post-surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Zhongyu Li, MD, PhD, Professor - Department of Orthopaedic Surgery
Organization: Wake Forest University Health Sciences
phone: 336-716-9520
e-mail: zli@wakehealth.edu



Responsible Party: Zhongyu Li, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00654615     History of Changes
Other Study ID Numbers: IRB00003715
GTS#32801 ( Other Identifier: Wake Forest University Health Sciences )
First Submitted: April 2, 2008
First Posted: April 8, 2008
Results First Submitted: April 3, 2017
Results First Posted: November 13, 2017
Last Update Posted: November 13, 2017