Wrist Fracture
Conditions
Keywords
Wrist Fracture
Brief summary
This research project is a multi-year proposal, with the goals of answering and evaluating the following: 1. 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? 2. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?
Interventions
PROCEDURESurgical treatment of distal radius fractures
Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
The following criteria must be met to be enrolled: 1. Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component 2. Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture 3. Be a male or non-pregnant female at least 18 years of age. 4. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol 5. Have the ability to understand and provide written authorization for use and disclosure of personal health information 6. 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: 1. Have any of the following conditions 1. Concomitant contralateral or ipsilateral upper extremity fractures 2. Ipsilateral ulna (excluding styloid) fracture 3. Open, multifragmentary fracture 4. Unstable distal radioulnar joint after fracture fixation 5. Artery or Nerve injury secondary to fracture 2. Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity 3. Currently on chemotherapy or radiation therapy 4. History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis 5. History of uncontrolled diabetes 6. History of active rheumatologic disease with deformity 7. History of chronic pain issues, psychiatric disorder which precludes reliable follow-up 8. Unable to provide consent for the study 9. Unable to make the follow-up appointments required of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain (to no pain) | Baseline to week 52 after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in range of motion measurements | Basline to week 52 after surgery | Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions. |
| Grip and Pinch | Baseline to week 52 after surgery | Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer. |
Countries
United States
Outcome results
None listed