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Clinical Trials/NCT01555372
NCT01555372
Unknown
Not Applicable

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

Shanghai Jiao Tong University School of Medicine1 site in 1 country40 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clavicle Injuries
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
40
Locations
1
Primary Endpoint
the postoperative complications
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
May 2014
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Leisheng Jiang

director of department of Orthopaedic,Xinhua hospital

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

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)

Outcomes

Primary Outcomes

the postoperative complications

Time Frame: 12 months

complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment

Secondary Outcomes

  • the affected limb function(3, 6, 9,12 months)

Study Sites (1)

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