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
  Purpose

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).


Condition Intervention
Clavicle Injuries
Device: Hook Plate
Device: Locking Plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hook Plate
20 participants will be enrolled in this group.
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.
Experimental: Locking Plates
20 paticipants will be enrolled in this group
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555372

Contacts
Contact: Jiang L sheng, doctor 008613002195209 jiangleisheng@126.com
Contact: Yang Y hua, master 008613402013616 yuesjtu@126.com

Locations
China
Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine Not yet recruiting
Shanghai, China, 200092
Contact: Jiang L sheng, doctor    008613002195209    jiangleisheng@126.com   
Contact: Yang Y hua, master    008613402013616    yuesjtu@126.com   
Sponsors and Collaborators
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
Investigators
Study Chair: Sheng L Jiang, doctor Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
  More Information

No publications provided

Responsible Party: Leisheng Jiang, director of department of Orthopaedic,Xinhua hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01555372     History of Changes
Other Study ID Numbers: U2032001
Study First Received: March 11, 2012
Last Updated: March 14, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
unstable distal clavicular fractures (Neer 2b)
Study Protocol
Fracture Fixation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014