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Nonsteroidal Anti-inflammatory Drug

drug for Elbow Surgery

N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 3, 6 and 12 mfup
Awards & highlights

Study Summary

Patients who present to our institution with a traumatic injury to their elbow who need operative management will be randomized to one of two groups; a treatment arm and a control arm. The treatment arm will receive a three-week postoperative course of indomethacin while the control group will not. We will follow both groups to assess whether or not indomethacin prophylaxis affects the rate of heterotopic ossification.

Eligible Conditions
  • Elbow Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 3, 6 and 12 mfup
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 3, 6 and 12 mfup for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in post operative radiographic evaluation
Secondary outcome measures
Disabilities of the Arm, Shoulder and Hand
Patient Rate Elbow Evaluation
The Mayo Elbow Performance score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: drugExperimental Treatment1 Intervention
The treatment arm will receive 21 days of Indomethacin and Pantoprazole (gastrointestinal protective agent). The patients will receive Indomethacin 25mg three times a day and Pantoprozole 40mg once a day.
Group II: placeboPlacebo Group1 Intervention
The placebo group will receive microcrystalline cellulose powder tablets to be taken as a control. The placebo will be dosed at the same intervals and duration as the treatment arm in this study.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,582 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
George Athwal 2012. "Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01744314.
All > Trauma > Protonix
~12 spots leftby Apr 2025
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