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| Name | Class |
|---|---|
| Nanjing Medical University | OTHER |
| The First People's Hospital of Huzhou | OTHER |
| Huai'an No. 2 People's Hospital | UNKNOWN |
| The First Affiliated Hospital of Nanchang University |
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The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b).
Controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (Neer 2b). The recognized treatment alternatives are Hook plate.Notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. Recently, Herrmann et al.and Largo et al.stabilized the distal clavicle with Locking plate (LP) and these studies offered encouraging support for LP. Because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hook Plate | Active Comparator | 20 participants will be enrolled in this group. |
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| Locking Plates | Experimental | 20 paticipants will be enrolled in this group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hook Plate | Device | All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with HP. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime. |
| Measure | Description | Time Frame |
|---|---|---|
| the postoperative complications | complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the affected limb function | the affected limb function measured using the Constant-Murley Score and using the Disabilities of the Arm, Shoulder and Hand (DASH) Score measured at 3, 6,9and 12months post-operatively. | 3, 6, 9,12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang L sheng, doctor | Contact | 008613002195209 | jiangleisheng@126.com | |
| Yang Y hua, master | Contact | 008613402013616 | yuesjtu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng L Jiang, doctor | Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine | Shanghai | 200092 | China |
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| Locking Plate | Device | All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with locking plate. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime. |
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