WRx Distal Radius Wrist Fracture Study

Study Overview
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Brief Summary
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This research project is a multi-year proposal, with the goals of answering and evaluating the following: Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate? Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?

Official Title
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The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.

Conditions
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Wrist Fracture

Intervention / Treatment
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* Procedure: Surgical treatment of distal radius fractures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The following criteria must be met to be enrolled: Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture Be a male or non-pregnant female at least 18 years of age. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol Have the ability to understand and provide written authorization for use and disclosure of personal health information Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side) Exclusion Criteria Subjects are excluded if: Have any of the following conditions Concomitant contralateral or ipsilateral upper extremity fractures Ipsilateral ulna (excluding styloid) fracture Open, multifragmentary fracture Unstable distal radioulnar joint after fracture fixation Artery or Nerve injury secondary to fracture Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity Currently on chemotherapy or radiation therapy History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis History of uncontrolled diabetes History of active rheumatologic disease with deformity History of chronic pain issues, psychiatric disorder which precludes reliable follow-up Unable to provide consent for the study Unable to make the follow-up appointments required of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgical treatment of distal radius fractures|Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain (to no pain) | Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain. | Baseline to week 52 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion measurements | Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions. | Basline to week 52 after surgery | 
| Grip and Pinch | Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer. | Baseline to week 52 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrist Fracture