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Too difficult to satisfy all the inclusion criteria.
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Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.
Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.
The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Will receive 500 mg Naproxen twice a day for two weeks |
|
| 2 | No Intervention | Will not receive naproxen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | 500 mg Naproxen twice a day for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| There is no difference in ulnohumeral flexion | 2 weeks |
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Inclusion Criteria:
Subjects aged 18 years or greater
Operative treatment of one of the following injuries
Exclusion Criteria:
An existing diagnosis of one of the following conditions
Pregnant or breast-feeding women
Concomitant use of one of the following drugs:
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| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD PhD | Mass General | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10660703 | Background | Viola RW, Hastings H 2nd. Treatment of ectopic ossification about the elbow. Clin Orthop Relat Res. 2000 Jan;(370):65-86. doi: 10.1097/00003086-200001000-00008. |
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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 |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |