Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial

Patients will be recruited from the principle investigator's practice at Athens Orthopedic Clinic. As the only hand and upper-extremity surgeon in the Athens-Clarke county metro area, principle investigator performs the majority of this type of surgery for patients in Athens and surrounding cities. Therefore, the study population should be largely representative of the target population.

Procedures:

1. Patient Identification: Patient presents with distal radius fracture.
2. An x-ray is taken to decide whether the fracture requires surgical stabilization.
3. Unstable distal radius fractures will be based on the following criteria:
4. Radial shortening <5 mm at the DRUJ compared with the contralateral side 2. Radial inclination on the posteroanterior radiographs > 15⁰ 3. Sagittal tilt on the lateral projection between 15⁰ dorsal tilt and 20⁰ volar tilt 4. Intra-articular step-off or gap <2 mm of the radiocarpal joint 5. Articular incongruity <2 mm of the sigmoid notch of the distal radius 2. Screening: Patients whose fracture is unstable will be assessed for eligibility using the aforementioned criteria.
5. Consent and de-identification: Patients who are deemed evaluable based on the eligibility criteria will be asked if they are interested in participating in a research study.
6. Those who are interested will meet with a member of the study team, who will explain the study and answer any questions the patient might have.
7. The participant will be given two (2) copies of the informed consent form and HIPAA authorization form. One copy of each document will be signed and returned to the study team, to be kept in a secure location, and the other copy will be given to the participant for his/her records.
8. Each study participant will be assigned a unique study identification number in order to keep his/her identity anonymous. The participant's name and study ID will be recorded on the first page of the case report form, which is detached and kept in a locked filing cabinet immediately following consent. All subsequent data collection will be recorded on the data collection form at follow-up visits with the principle investigator. Data will be entered into a secure, de-identified database by a member of the study team, using the patient's study ID as an identifier. The database will not contain any information that may be used to identify the patient. 4. Surgery: All fractures will be stabilized by volar plate fixation or closed reduction percutaneous pinning using a distal volar radial locking plate or other appropriate implant. 5. Randomization: To avoid any potential bias on the part of the surgeon, patients will be randomized postoperatively to receive either the investigational (glove) or control (no glove) intervention. Therefore, the surgeon will be blinded to intervention status until after patient enrollment and surgical stabilization. 6. Post-surgery: The wound will be dressed steriley, per standard protocol. Initial sterile cast padding will be placed over sterile dressing. For patients in the investigational group, the compression glove will be applied over cast padding, followed by additional padding and then a splint. Patients in the control group will be dressed identically, with the exception of glove application. The splint will be applied for two weeks post-surgery and removal of the splint and application of a short-arm cast will occur at five weeks post-surgery. Additional post-surgical procedures are as follows:
9. 2 weeks- splint is removed; glove is taken off for edema measurements (investigational group); short- arm cast is applied b. 5 weeks- short-arm cast is removed; patient can continue to wear compression glove on an as-needed basis; patient is given post-operative exercise handout c. 3 months- patients meet with study physician for routine follow-up visit d. 6 months- patients meet with study physician for final follow-up visit; once fully healed, patient is given option of having plates removed 7. Therapy: Patients will be given a handout explaining post-operative exercises to be performed at home during recovery.
10. In addition, participants will attend therapy twice weekly, beginning five weeks from surgery. Duration of therapy will be as-needed at the therapist's discretion. Discharge from therapy will be based on the therapist's assessment that the patient has recovered to the extent that they can continue an exercise program at home.
11. Patients who stop coming to therapy prior to discharge will be contacted by the therapists and asked to provide his/her primary reason for not returning. 8. Outcome assessment: outcomes will be assessed at each of four follow-up visits, occurring two weeks, six weeks, three months, and six months from surgery. These coincide with regular post-operative visits, so as to minimize loss to follow-up. Each visit will assess each of the outcome measurements explained in later sections.