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

This study is not yet open for participant recruitment.
Verified March 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Collaborators:
Nanjing Medical University
the First People's Hospital of Huzhou
Huai'an No. 2 People's Hospital
The First Affiliated Hospital of Nanchang University
Information provided by (Responsible Party):
Leisheng Jiang, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01555372
First received: March 11, 2012
Last updated: March 14, 2012
Last verified: March 2012

March 11, 2012
March 14, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
the postoperative complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment
Same as current
Complete list of historical versions of study NCT01555372 on ClinicalTrials.gov Archive Site
the affected limb function [ Time Frame: 3, 6, 9,12 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Clavicle Injuries
  • Device: Hook Plate
    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.
  • Device: Locking Plate
    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.
  • Active Comparator: Hook Plate
    20 participants will be enrolled in this group.
    Intervention: Device: Hook Plate
  • Experimental: Locking Plates
    20 paticipants will be enrolled in this group
    Intervention: Device: Locking Plate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
May 2014
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact: Jiang L sheng, doctor 008613002195209 jiangleisheng@126.com
Contact: Yang Y hua, master 008613402013616 yuesjtu@126.com
China
 
NCT01555372
U2032001
Yes
Leisheng Jiang, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
  • Nanjing Medical University
  • the First People's Hospital of Huzhou
  • Huai'an No. 2 People's Hospital
  • The First Affiliated Hospital of Nanchang University
Study Chair: Sheng L Jiang, doctor Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
Shanghai Jiao Tong University School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP