Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01118715 |
| Other study ID # |
DRF-001 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2010 |
| Est. completion date |
September 2017 |
Study information
| Verified date |
October 2020 |
| Source |
J&M Shuler |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Distal radius fractures (DRF) are the most common type of fracture in the human body, and a
large proportion of DRFs result in complications. Previously proposed preventive strategies
have questionable efficacy and may impose additional risks on the patient. Because many
complications secondary to distal radius fractures are associated with excessive swelling, a
prophylactic means for edema reduction could dramatically reduce morbidity among this
population. A compression glove is a non-invasive, non-pharmacological way to reduce edema.
Previous studies have confirmed its utility in edema reduction after hand trauma and among
patients with chronic inflammatory conditions, but none have sufficiently investigated the
application to patients with distal radius fractures, a population in which this intervention
could have a large impact. The investigators propose a randomized controlled trial to
evaluate use of a compression glove during recovery among patients who have sustained an
unstable distal radius fracture. The investigators hypothesize that patients who wear a
compression glove after a distal radius fracture:
- Will experience less edema
- Will demonstrate greater functionality
- Will recover more quickly
- Will have lower incidence rates of carpal tunnel syndrome
- Will have lower incidence rates of complex regional pain syndrome
Description:
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.
1. An x-ray is taken to decide whether the fracture requires surgical stabilization.
2. Unstable distal radius fractures will be based on the following criteria:
1. 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.
3. 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.
1. 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.
2. 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.
3. 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:
a. 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.
1. 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.
2. 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.
