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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05655130
Other study ID # R20180096
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 6, 2018
Est. completion date May 2, 2023

Study information

Verified date January 2024
Source Indiana Hand to Shoulder Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Dexamethasone
Intraoperative 10 mg IV Dose
Methylprednisolone
The oral methylprednisolone taper course will begin on the day of surgery and will taper as noted below: Day 1: 24 mg orally (8 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 2: 20 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 8 mg at bedtime) Day 3: 16 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg after dinner; 4 mg at bedtime) Day 4: 12 mg orally (4 mg before breakfast; 4 mg after lunch; 4 mg at bedtime) Day 5: 8 mg orally (4 mg before breakfast; 4 mg at bedtime) Day 6: 4 mg orally (4 mg before breakfast)
Other:
Standard of Care
standard of care surgery

Locations

Country Name City State
United States Indiana Hand to Shoulder Center Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana Hand to Shoulder Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Return to Work comparison of patient's work schedule/limitations from baseline to 6 months (off study) 6 months
Primary Range of Motion Active and Passive degrees of flexion, extension in the wrist. Forearm degrees of supination and pronation comparison of 10 days to 6 months post-operative measurements
Secondary Visual Analogue Scale (VAS) Pain patient rates pain on a visual scale from no pain to worst possible pain 6 Months
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