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).

Study Overview

• Status: Unknown
• Conditions: Clavicle Injuries
• Intervention / Treatment: 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
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200092
    • Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 9,12 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: The First Affiliated Hospital of Nanchang University; Nanjing Medical University; The First People's Hospital of Huzhou; Huai'an No. 2 People's Hospital
• Investigators: Study Chair: Sheng L Jiang, doctor, Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: March 11, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Fracture Fixation; unstable distal clavicular fractures (Neer 2b); Study Protocol
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: U2032001