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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01555372

Enrollment

Registered

2012-03-15

Start date

2012-05-31

Completion date

2014-05-31

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Injuries

Keywords

unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation

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.

Interventions

DEVICEHook 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.

DEVICELocking 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactJiang L sheng, doctor

jiangleisheng@126.com008613002195209

Backup ContactYang Y hua, master

yuesjtu@126.com008613402013616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026