Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture
| Registry | NCT05655130 |
|---|---|
| Status | Terminated - Low participation rate |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | Indiana Hand to Shoulder Center (Other) |
| Conditions | Fractures, Bone, Fractures, Closed, Radius Fracture Distal |
| Interventions | Dexamethasone, Methylprednisolone, Standard of Care (Drug, other) |
| Dates | start 2018-11-06, primary completion 2023-05-02, completion 2023-05-02, first posted 2022-12-19, last updated 2024-01-23 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Fractures, Bone All trials for Fractures, Closed All trials of Dexamethasone All trials of Methylprednisolone
The primary goal of this study is to compare functional outcomes (range of motion \[flexion, extension, supination, pronation\], return to work, of patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. Secondary goals include comparison of pain control (number of pain pills consumed, visual analog scale (VAS) pain scores) between patients with distal radius fractures who receive intraoperative glucocorticoids to those that do not. The primary endpoint of this study will occur when 18 patients in each test-group complete the 6 month follow up visit for study.
This will be a prospective, randomized, partially blinded, controlled trial where patients are randomized in a centralized fashion into 2 groups: a) Control group with no intraoperative glucocorticoids administered or b) Test group with administration of 10 mg glucocorticoids intraoperatively followed with a 6-day oral methylprednisolone taper course prescribed as a Medrol Dose Pack. Each group will enroll 30 patients for a study total of 60 over approximately a one year enrollment period. Randomization will be set up using sealedenvelope.com simple randomizer. The randomization process will ensure balance between both arms based on sex and age of patients enrolled. All patients scheduled for distal radius ORIF will be screened to meet inclusion/exclusion criteria. Patients will be randomized preoperatively by the research coordinator, based on a 1:1 weighting, upon obtaining to consent to either Control or Test group. Post-op therapists will be blinded to the patient treatment group until completion of protocol activities for each patient.
After surgery, patients will be followed for a duration of at least 6 months. Interval follow-up information will be collected at 10 days, 6 weeks, 3 months, and 6 months.
3-view wrist radiographs will be taken at each follow-up visit.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test Group | Experimental | Drug: Dexamethasone; Drug: Methylprednisolone | Test Group will receive 10mg intravenous dexamethasone at the time of incision, administered by the assigned anesthesiologist. Post-surgery, Test Group patients will be prescribed a 6-day oral methylprednisolone taper course. |
| Control Group | Other | Other: Standard of Care | Standard of care with no placebo |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Intra- or extra-articular distal radius fractures (AO 23-A2,3; 23B-1,2,3; 23C-1,2,3) treated with open reduction internal fixation (ORIF) * Age >18 Exclusion Criteria: * Open fractures * Pathologic fractures * Concomitant ipsilateral upper extremity fracture (not including distal ulna) * Medical contraindication to systemic glucocorticoids (insulin-dependent Diabetes mellitus, history of avascular necrosis, allergy) * Narcotic dependence * Women who are pregnant or breastfeeding
| Facility | City | Country | Status |
|---|---|---|---|
| Indiana Hand to Shoulder Center | Indianapolis, Indiana | United States |