Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate

Conditions
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Clavicle Injuries

Intervention / Treatment
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* Device: Hook Plate
* Device: Locking Plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures. Normal shoulder functions before injury. Internal fixation with either HP or LP. The subjects were in good health and were able to comply with all prescribed follow-up procedures. Exclusion Criteria: Patients who present multiple traumas. Patients with other serious injuries to either upper limb that would interfere with rehabilitation. Patients with a pathological, recurrent or open clavicle fracture. Patient unwilling to give written informed consent. Patients with cognitive impairment unable to comply with treatment programme. Patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and Paget's disease)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hook Plate<br>20 participants will be enrolled in this group. | Device: Hook Plate<br>* 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.<br>|
| Experimental: Locking Plates<br>20 paticipants will be enrolled in this group | Device: Locking Plate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation