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

Primary Purpose

Clavicle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hook Plate
Locking Plate
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Injuries focused on measuring unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hook Plate

Locking Plates

Arm Description

20 participants will be enrolled in this group.

20 paticipants will be enrolled in this group

Outcomes

Primary Outcome Measures

the postoperative complications
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
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.

Full Information

First Posted
March 11, 2012
Last Updated
March 14, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT01555372
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Injuries
Keywords
unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hook Plate
Arm Type
Active Comparator
Arm Description
20 participants will be enrolled in this group.
Arm Title
Locking Plates
Arm Type
Experimental
Arm Description
20 paticipants will be enrolled in this group
Intervention Type
Device
Intervention Name(s)
Hook Plate
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Locking Plate
Intervention Description
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 Measure Information:
Title
the postoperative complications
Description
complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the affected limb function
Description
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.
Time Frame
3, 6, 9,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang L sheng, doctor
Phone
008613002195209
Email
jiangleisheng@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Y hua, master
Phone
008613402013616
Email
yuesjtu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng L Jiang, doctor
Organizational Affiliation
Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang L sheng, doctor
Phone
008613002195209
Email
jiangleisheng@126.com
First Name & Middle Initial & Last Name & Degree
Yang Y hua, master
Phone
008613402013616
Email
yuesjtu@126.com

12. IPD Sharing Statement

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

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