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

NCT01555372 | Unknown DMC

• 1 other identifier: U2032001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Clavicle Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the affected limb function

  3, 6, 9,12 months

Study Arms (2)

Hook Plate

ACTIVE COMPARATOR

20 participants will be enrolled in this group.

Device: Hook Plate

Locking Plates

EXPERIMENTAL

20 paticipants will be enrolled in this group

Device: Locking Plate

Interventions

Hook Plate DEVICE

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.

Hook Plate

Locking Plate DEVICE

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.

Locking Plates

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Nanjing Medical University: collaborator
• The First People's Hospital of Huzhou: collaborator
• Huai'an No. 2 People's Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

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

Shanghai, 200092, China

Location

Study Officials

• Sheng L Jiang, doctor

  Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital

  STUDY CHAIR

Central Study Contacts

Jiang L sheng, doctor

CONTACT

008613002195209; jiangleisheng@126.com

Yang Y hua, master

CONTACT

008613402013616; yuesjtu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of Orthopaedic,Xinhua hospital

Study Record Dates

• First Submitted: March 11, 2012
• First Posted: March 15, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

CN (1)