Distal Radius Fracture
Conditions
Brief summary
The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.
Interventions
DRUGDexamethasone
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone
DRUGMethylprednisolone
Postoperative: A 6-day oral methylprednisolone (oral GC) taper course. The oral GC taper course begins on the day of surgery and includes 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day 6
Sponsors
C. Liam Dwyer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient 18 years of age and older. * Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release
Exclusion criteria
* Worker's compensation patient * Non-operatively treated fractures * Open fractures * Preoperative neurovascular injury * Coexisting fractures or injuries * Diabetes mellitus * Allergy or contraindication to GCs * Associated non-orthopedic injury that would prohibit the administration of GCs * Patients currently incarcerated * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QuickDASH | Pre-Op (day of consent) up through 12 months Post-Op | QuickDash scale is designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper extremity (arm, shoulder, and hand). Scale is 0-100, with 0 being no disability (best outcome) and 100 being full disability (worst outcome). |
| Visual Analog Scale Pain Score | Pre-Op (day of consent) up through 12 months Post-Op | Visual Analog Scale Pain Score is a subjective pain scale reported by patients to assess current pain levels for their condition being seen in clinic. Scale is 0-10, with 0 being no pain at all (best outcome), 10 being worst pain imaginable (worst outcome). |
| PROMIS Pain Interference | Pre-Op visit (day of consent) | PROMIS Pain Interference scale measuring how pain impacts daily activities, social life, and emotional well-being. Scale is 40.7- 77 with 40.7 being the no impact on activity (best outcome), and 77 being worst impact on daily activity (worst outcome). |
| PROMIS Self-Efficacy Manage Symptoms | Pre-Op (day of consent) | PROMIS Self-Efficacy Manage Symptoms is a scale that measures a person's confidence in managing symptoms, such as pain or fatigue, and preventing them from interfering with daily life. Scale is 22.67-63.85 with 22.67 meaning no confidence in managing symptoms (worst outcome) and 63.85 being full confidence in managing symptoms (best outcome). |
| PROMIS Upper Extremity (Short Form 7A) | Pre-Op (day of consent) up through 12 months Post-Op | PROMIS Upper Extremity Scale measures the self-reported functioning of the arms, shoulders, hands, and fingers. Scale is 16.3-58.2, with 16.3 being severe functional impact (worst outcome) and 58.2 being no functional issues (best outcome). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLiam Dwyer, MD
Geisinger Clinic
Participant flow
Recruitment details
Study discontinued due to departure of research staff and changes in institutional priorities. Study failed to meet enrollment goals of 200 total participants (n=100/study arm). No analysis was completed, and study was administratively closed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 20 |
| other Total, other adverse events | 1 / 15 | 0 / 20 |
| serious Total, serious adverse events | 0 / 15 | 0 / 20 |
Outcome results
None listed