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

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ClinicalTrials.gov Identifier: NCT01555372
Recruitment Status : Unknown
Verified March 2012 by Leisheng Jiang, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Collaborators:
Nanjing Medical University
First People's Hospital Affiliated to Huzhou University
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

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).

Condition or disease Intervention/treatment
Clavicle Injuries Device: Hook Plate Device: Locking Plate

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the affected limb function [ Time Frame: 3, 6, 9,12 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First People's Hospital Affiliated to Huzhou University
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

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
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

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