Clinical trial NCT01555372: Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
Official title: Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clavicle Injuries
Keywords: unstable distal clavicular fractures (Neer 2b)
Study Protocol
Fracture Fixation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
name: The First People's Hospital of Huzhou
name: Huai'an No. 2 People's Hospital
name: The First Affiliated Hospital of Nanchang University
First posted: 2012-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years
2. Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures.
3. Normal shoulder functions before injury.
4. Internal fixation with either HP or LP.
5. The subjects were in good health and were able to comply with all prescribed follow-up procedures.

Exclusion Criteria:

1. Patients who present multiple traumas.
2. Patients with other serious injuries to either upper limb that would interfere with rehabilitation.
3. Patients with a pathological, recurrent or open clavicle fracture.
4. Patient unwilling to give written informed consent.
5. Patients with cognitive impairment unable to comply with treatment programme.
6. Patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and Paget's disease)

Primary outcomes:
measure: the postoperative complications
timeFrame: 12 months
Secondary outcomes:
measure: the affected limb function
timeFrame: 3, 6, 9,12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
name: Sheng L Jiang, doctor
role: STUDY_CHAIR
References: