Recruiting

Indomethacin

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT01744314

Conditions

Elbow Trauma Requiring Operative Management

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Indomethacin and Pantoprazole

microcrystalline cellulose powder tablets

Study Details

Brief 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.

Conditions

Elbow Trauma Requiring Operative Management

Study ID

NCT01744314

Start date

Nov, 2012

Status verified date

Mar, 2017

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: drug

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.

placebo comparator: placebo

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.

Interventions

Indomethacin and Pantoprazole

microcrystalline cellulose powder tablets

Primary outcome measure

  • change in post operative radiographic evaluation [ Time Frame: 6 weeks and 3, 6 and 12 mfup ]

Central Contacts and Locations

Central contacts

George Athwal, MD

519-646-6100<gathwal@uwo.ca>

Kate Kelly, MSc, MPH

519-646-6100Kate.Kelly@sjhc.london.on.ca

Locations

HULC, St Joseph's Health Care

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

George Athwal, MD

519-646-6100gathwal@uwo.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 23, 2017

Last verified

Mar, 2017

Keywords

  • Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-03-23.