Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Lawson Health Research Institute

Status: Unknown

Conditions: Elbow Trauma Requiring Operative Management

Treatments: Drug: Indomethacin and Pantoprazole; Drug: microcrystalline cellulose powder tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01744314

102903

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Terrible Triad
• Radial head fracture surgical treatment
• Monteggia and Trans-olecranon Fracture Dislocations
• Distal Biceps Tendon Injuries
• Distal Humerus Fractures
• Coronoid Fractures
• Capitellar-Trochlear fractures
• Olecranon Fractures

Exclusion criteria

• Associated Traumatic Brain Injury
• Burn Injuries associated with elbow trauma
• History of Gastric Ulcers
• Documented allergies to any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Severe Asthma
• Previous operative fixation to affected elbow
• Participation in other research study
• Inability to speak / understand English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

drug

Experimental group

Description:

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.

Treatment:

Drug: Indomethacin and Pantoprazole

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: microcrystalline cellulose powder tablets