Elbow Trauma Requiring Operative ManagementNCT01744314
Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma
A study testing Indomethacin and Pantoprazole and microcrystalline cellulose powder tablets in people with Elbow Trauma Requiring Operative Management, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elbow Trauma Requiring Operative Management
- What is being tested?
- Indomethacin and Pantoprazole and microcrystalline cellulose powder tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
HULC, St Joseph's Health Care
London, Ontario, N6A 4V2
George Athwal, MD, 519-646-6100, gathwal@uwo.ca
About this study
Official title: Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
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.
- Being tested
- Indomethacin and Pantoprazole, microcrystalline cellulose powder tablets
- Keywords
- Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin and PantoprazoleDrug
microcrystalline cellulose powder tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| drug | Experimental | 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. Receives: Drug: Indomethacin and Pantoprazole |
| placebo | Placebo comparator | 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. Receives: Drug: microcrystalline cellulose powder tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks and 3, 6 and 12 mfup
Secondary outcomes (4)
change in range of motion
measuring range of motion with a goniometer will be performed at 6 weeks and 3, 6 and 12 mfup
Measured: 6 weeks and 3, 6 and 12 mfup
Patient Rate Elbow Evaluation
is a 20-item questionnaire designed to measure elbow pain and disability
Measured: 6 weeks and 3, 6 and 12 mfup
The Mayo Elbow Performance score
is an instrument used to test the limitations to use the elbow during ADL caused by the pathology
Measured: 6 weeks and 3, 6 and 12 mfup
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.
Measured: 6 weeks and 3, 6 and 12 mfup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Trauma Requiring Operative ManagementStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Athwal, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744314
- Sponsor's protocol ID
- 102903
- Status last verified
- Mar 2017
- First submitted
- 19 Nov 2012
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indomethacin Prophylaxis for Heterotopic Ossification After Surgical Treatment of Elbow Trauma: A Randomized Prospective Double-blinded Study.
- ClinicalTrials.gov ID
- NCT01744314
- Acronym / sponsor ID
- 102903
- Keywords
- Elbow trauma,Heterotopic Ossification,Indomethacin, Prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug | Experimental | Drug: Indomethacin and PantoprazoleThe 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 | Placebo comparator | Drug: microcrystalline cellulose powder tabletsThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Terrible Triad
- Radial head fracture surgical treatment
- Monteggia and Trans-olecranon Fracture Dislocations
- Distal Biceps Tendon Injuries
- Distal Humerus Fractures
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin and Pantoprazole | Drug | drug |
| microcrystalline cellulose powder tablets | Drug | placebo |
Primary outcome
change in post operative radiographic evaluation
Time frame: 6 weeks and 3, 6 and 12 mfup
AS a standard care patients will be routinely assess at three, six , twelve and twenty four months post-operatively.
4 secondary outcomes
change in range of motion
Time frame: 6 weeks and 3, 6 and 12 mfup
Patient Rate Elbow Evaluation
Time frame: 6 weeks and 3, 6 and 12 mfup
The Mayo Elbow Performance score
Time frame: 6 weeks and 3, 6 and 12 mfup
Disabilities of the Arm, Shoulder and Hand
Time frame: 6 weeks and 3, 6 and 12 mfup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Canadian Orthopaedic AssociationLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indomethacin and Pantoprazole and microcrystalline cellulose powder tablets in people with Elbow Trauma Requiring Operative Management, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Athwal, MD (519-646-6100 ext. 66081, <gathwal@uwo.ca>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in post operative radiographic evaluation (time frame: 6 weeks and 3, 6 and 12 mfup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.