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Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

Primary Purpose

Elbow Trauma Requiring Operative Management

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Indomethacin and Pantoprazole
microcrystalline cellulose powder tablets
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Trauma Requiring Operative Management focused on measuring Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • HULC, St Joseph's Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

drug

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

change in post operative radiographic evaluation
AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.

Secondary Outcome Measures

change in range of motion
measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup
Patient Rate Elbow Evaluation
is a 20-item questionnaire designed to measure elbow pain and disability
The Mayo Elbow Performance score
is an instrument used to test the limitations to use the elbow during ADL caused by the pathology
Disabilities of the Arm, Shoulder and Hand
is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.

Full Information

First Posted
November 19, 2012
Last Updated
March 22, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01744314
Brief Title
Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
Official Title
Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Trauma Requiring Operative Management
Keywords
Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indomethacin and Pantoprazole
Intervention Type
Drug
Intervention Name(s)
microcrystalline cellulose powder tablets
Primary Outcome Measure Information:
Title
change in post operative radiographic evaluation
Description
AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.
Time Frame
6 weeks and 3, 6 and 12 mfup
Secondary Outcome Measure Information:
Title
change in range of motion
Description
measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup
Time Frame
6 weeks and 3, 6 and 12 mfup
Title
Patient Rate Elbow Evaluation
Description
is a 20-item questionnaire designed to measure elbow pain and disability
Time Frame
6 weeks and 3, 6 and 12 mfup
Title
The Mayo Elbow Performance score
Description
is an instrument used to test the limitations to use the elbow during ADL caused by the pathology
Time Frame
6 weeks and 3, 6 and 12 mfup
Title
Disabilities of the Arm, Shoulder and Hand
Description
is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.
Time Frame
6 weeks and 3, 6 and 12 mfup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Athwal, MD
Phone
519-646-6100
Ext
66081
Email
<gathwal@uwo.ca>
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Kelly, MSc, MPH
Phone
519-646-6100
Ext
64640
Email
Kate.Kelly@sjhc.london.on.ca
Facility Information:
Facility Name
HULC, St Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Athwal, MD
Phone
519-646-6100
Email
gathwal@uwo.ca

12. IPD Sharing Statement

Links:
URL
http://www.coa-aco.org/
Description
Canadian Orthopaedic Association

Learn more about this trial

Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma

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