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

Not Applicable

• Conditions: Clavicle Injuries
• Interventions: Device: Hook Plate; Device: Locking Plate

• Registration Number: NCT01555372
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Study First Posted: 2012-03-15
• Last Update Posted: 2012-03-15
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hook Plate	Hook Plate	20 participants will be enrolled in this group.
Locking Plates	Locking Plate	20 paticipants will be enrolled in this group

Primary Outcome Measures

Name	Time	Method
the postoperative complications	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

Name	Time	Method
the affected limb function	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.

Trial Locations

Locations (1)

Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China