Ossification, HeterotopicNCT01631669
Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
A study testing Celecoxib in people with Ossification, Heterotopic, run by Walter Reed National Military Medical Center at 2 sites in 2 countries.
Trial summary
Hypotheses: H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ossification, Heterotopic
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Jun 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
- Extremity Wound ≥75cm2 requiring operative intervention
- Minimal age of 18 years
Who cannot join
- The following co-morbidities will result in exclusion from study:
- Coronary Artery Disease,
- Diabetes Mellitus (IDDM or T2DM),
- Peripheral Vascular Disease,
- Age >65,
- Connective tissue disorders,
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- Immunosuppression,
- Clinically-evident peptic ulcer disease,
- Substantial renal dysfunction (as assessed by a serum creatinine >1.5 or calculated creatinine clearance of <50),
- Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,
- Severe penetrating or hemorrhagic traumatic brain injury,
- Endoscopic gastrointestinal interventions,
- Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.
- Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.
- History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.
- Hepatic Impairment
- Warfarin
- Lithium
- Drugs known to inhibit CYP2C9 Liver Enzymes
- Subjects known or suspected to be poor CYP2C9 metabolizers
- Concomitant use with ACE Inhibitors and Angiotension II Antagonists
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Walter Reen National Military Medical Center Bethesda
Bethesda, Maryland, 20889
Jonathan A Forsberg, MD, 301-319-3403, jonathan.forsberg@med.navy.mil
Frederick A Gage, 301-319-8592, frederick.gage@med.navy.mil
Germany1 site, 1 recruiting
- Recruiting
Landstuhl Military Medical Center
Landstuhl
Brett Freedman, MD, brett.freedman@amedd.army.mil
Brett Freedman, MD
About this study
Official title: Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Hypotheses:
H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls.
H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification.
H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification
Read the detailed description
This study is a prospective, randomized, controlled clinical trial.
- Conditions
- Ossification, Heterotopic
- Being tested
- Celecoxib
- Keywords
- Ossification, Heterotopic Ossification
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
200 mg Q 12 hours orally
| Study group | Role | What they receive |
|---|---|---|
| Celebrex | Experimental | Receive Celebrex Receives: Drug: Celecoxib |
| Control | No intervention | no placebo administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Incidence and severity of HO
Measured: 3 years
Secondary outcomes (1)
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
- Overall rate of impaired wound healing.
- Overall time to fracture union (if applicable)
- Overall rate of nonunions (if applicable)
- Overall rate of drug-related complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ossification, HeterotopicStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan A Forsberg, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631669
- Sponsor's protocol ID
- 352511
- Other IDs
- 110587
- Status last verified
- Jun 2012
- First submitted
- 27 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.
PubMed 19411456Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.
PubMed 17332095
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01631669
- Acronym / sponsor ID
- 352511
- Conditions
- Ossification, Heterotopic
- Keywords
- Ossification, Heterotopic Ossification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- May 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 29 Jun 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.
Hypotheses:
H1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls.
H2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification.
H2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification
Detailed description
This study is a prospective, randomized, controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celebrex | Experimental | Drug: CelecoxibReceive Celebrex |
| Control | No intervention | –no placebo administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)
- Extremity Wound ≥75cm2 requiring operative intervention
- Minimal age of 18 years
Key exclusion criteria (21 listed)
- Coronary Artery Disease,
- Diabetes Mellitus (IDDM or T2DM),
- Peripheral Vascular Disease,
- Age >65,
- Connective tissue disorders,
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 |
|---|---|---|
| CelecoxibAlso: Celebrex200 mg Q 12 hours orally | Drug | Celebrex |
Primary outcome
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Time frame: 3 years
Incidence and severity of HO
1 secondary outcome
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
- Background: PubMed 19411456Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.
- Background: PubMed 17332095Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.
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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.
Jonathan A Forsberg, MD principal investigator
Walter Reed National Military Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celecoxib in people with Ossification, Heterotopic, run by Walter Reed National Military Medical Center at 2 sites in 2 countries.
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 3 inclusion and 21 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 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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. 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 Jonathan A Forsberg, MD (301-319-3403, jonathan.forsberg@med.navy.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631669, which also lists 2 linked publications.
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 3 Jul 2012.