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Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT03898154
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
C. Liam Dwyer, Geisinger Clinic

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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Drug: Dexamethasone Drug: Methylprednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glucocorticoid (GC) group
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone 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
Drug: Dexamethasone
Intraoperative: Single intraoperative dose of 10 mg intravenous dexamethasone

Drug: Methylprednisolone
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

No Intervention: Control (non-GC) group
No GC administration



Primary Outcome Measures :
  1. QuickDASH [ Time Frame: 0-12 months ]
    best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand

  2. Visual Analog Scale Pain Score [ Time Frame: 0-12 months ]
    best 0-10 worst; continuous scale to measure current pain level

  3. PROMIS Pain Interference [ Time Frame: 0-12 months ]
    best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle

  4. PROMIS Self-Efficacy Manage Symptoms [ Time Frame: 0-12 months ]
    best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure

  5. PROMIS Upper Extremity [ Time Frame: 0-12 months ]
    worst 0-100 best; measures physical function of upper extremities



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898154


Contacts
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Contact: Liam Dwyer, MD 570-214-4806 orthoresearch@geisinger.edu

Locations
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United States, Pennsylvania
Geisinger Woodbine Recruiting
Danville, Pennsylvania, United States, 17821
Contact: Jennifer Harding, MPA    570-214-6178    jlharding1@geisinger.edu   
Sponsors and Collaborators
C. Liam Dwyer
Investigators
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Principal Investigator: Liam Dwyer, MD Geisinger Clinic

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Responsible Party: C. Liam Dwyer, Staff Physician, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03898154     History of Changes
Other Study ID Numbers: 2018-0533
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Dexamethasone
Dexamethasone acetate
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents