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This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percuataneous plate fixation | an approach with three small longitudinal incisions |
| |
| open plate fixation | large transverse incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xrays | Other | xrays from 2 week postop to 5 year postop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score | The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness. | 1+ year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Incision numbness at surgical site. | Our secondary outcome measures will be union, malunion, and nonunion rates between these two methods, as well as infection rates and functional and satisfaction outcomes based on subjective questioning and the DASH and Constant shoulder score questionnaires. Our null hypothesis for these secondary outcomes is that there will be no difference between the two treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated surgically for diaphysial clavicle fracture.
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| Name | Affiliation | Role |
|---|---|---|
| Erik Kubiak, MD | University of Utah | Principal Investigator |
| Thomas Christensen, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopedic Center | Salt Lake City | Utah | 84121 | United States |
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| ID | Term |
|---|---|
| D006987 | Hypesthesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |