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The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.
the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.
the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.
biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| superior group | Experimental | this group with midshaft clavicle fracture were treated with superior reconstruction plate |
|
| anteroinferior group | Experimental | this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction Internal Fixation superior plate | Procedure | 3.5mm superior reconstruction plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 30 days after surgery |
| Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 60 days after surgery |
| Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 90 days after surgery |
| Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 365 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 30 days after surgery |
| Visual Analogue Scale score (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Manrique, MD | UMAE Hospital de Traumatologia y Ortopedia de Puebla | Principal Investigator |
| Gustavo Rivera Saldivar, MD | UMAE Hospital de Traumatologia y Ortopedia de Puebla | Study Chair |
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randomized clinical trial
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the patient and the outcomes analyzer were masked
| Open Reduction Internal Fixation anteroinferior plate | Procedure | 3.5mm anteroinferior reconstruction plate |
|
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
| 60 days after surgery |
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 90 days after surgery |
| Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 365 days after surgery |