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| ID | Type | Description | Link |
|---|---|---|---|
| 110587 | Other Identifier | FDA IND |
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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
This study is a prospective, randomized, controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celebrex | Experimental | Receive Celebrex |
|
| Control | No Intervention | no placebo administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg Q 12 hours orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial | Incidence and severity of HO | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial |
| 3 years |
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Inclusion Criteria:
Exclusion Criteria:
The following co-morbidities will result in exclusion from study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan A Forsberg, MD | Contact | 301-319-3403 | jonathan.forsberg@med.navy.mil | |
| Frederick A Gage | Contact | 301-319-8592 | frederick.gage@med.navy.mil |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan A Forsberg, MD | Walter Reed National Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reen National Military Medical Center Bethesda | Recruiting | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19411456 | Background | 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. | |
| 17332095 | Background | Potter 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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| ID | Term |
|---|---|
| D009999 | Ossification, Heterotopic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Landstuhl Military Medical Center | Recruiting | Landstuhl | Germany |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |