Distal Radius Steroid

Fractures, Bone Clinical Trial

Official title:

Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05655130
• Other study ID #: R20180096
• Status: Terminated
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Closed
• Radius Fracture Distal
• Radius Fractures

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