Distal Radius Fracture
Conditions
Brief summary
The purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). Currently there is no consensus for post-operative protocol following fixation of distal radius fractures. The decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. The goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.
Detailed description
188 patients treated for distal radius fractures with open reduction internal fixation using volar locked plating will be split into two study groups: a group that is immobilized in a splint post operatively and given formal physical therapy and a group that does not receive either of these post operative interventions. The primary outcome will be loss of fixation. Secondary outcomes will include pain, cost, Quick Dash, range of motion, and grip strength. Data will be recorded at the pre-operative visit, as well as at post-operative visits at 2 weeks, 6 weeks, 3 months and 6 months.
Interventions
OTHERSplint
Participants will have their open reduction internal fixation of distal radius fractures treated with volar locked plating. for 2 weeks. Which will be replaced by a custom thermoplastic splint for 5 weeks.
BEHAVIORALFormal Physical Therapy
Participants will also receive a prescription for formal physical therapy. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks.
BEHAVIORALSelf directed physical therapy
Participants will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.
OTHERSoft dressing (No Splint)
Participants will have their open reduction internal fixation of distal radius fractures placed in a soft dressing which will be kept in place for 2 weeks.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws. 1. \> 10 degrees of dorsal tilt 2. Volar displacement (Volar Barton's type fracture) 3. Shortening \> 3 mm 4. Intra-articular displacement or step off \> 2mm.
Exclusion criteria
* Ipsilateral upper limb concomitant fracture * Fracture fixation other than volar locked plating and screws * Dislocation or neurologic injury * Gustilo-Anderson grade III open fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Loss of fixation | 2 weeks, 4 weeks, 12 weeks, 24 weeks | The loss of fixation will be measured by the change in radiologic outcomes (in degrees) from 2-week post-operative visit to follow-up visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient comfort/pain (VAS) | Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks | This will be measured by the Visual Analogue Scale (VAS) which measures pain using a 10 point scale. On a scale of 1-10 where following pain scale is: no pain (0), mild pain(1-3), moderate pain (4-6), and severe pain (7-10). |
| Change in wrist range mobility | 2 weeks, 4 weeks, 12 weeks, 24 weeks | Range of motion will be measured using goniometers. |
| Change in wrist range mobility using DASH | 2 weeks, 4 weeks, 12 weeks, 24 weeks | This is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. |
| Change in Grip strength | 2 weeks, 4 weeks, 12 weeks, 24 weeks | Physical examinations through the study will record the grip strength (kgs) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJadie De Tolla, MD
NYU Langone Health
Outcome results
None listed