Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft

• Conditions: Humeral Fractures
• Interventions: Procedure: Conservative Treatment; Procedure: Operative Plate Fixation

• Registration Number: NCT03358173
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Detailed Description

From Jane 2015 to October 2016, patients with displaced humeral shaft fractures are retrospectively included in this study, they were treated with either operative plate or conservative treatment. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(DASH score) between the 2 groups at 1 year after surgery.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2017-11-26
• Last Update Submitted: 2017-11-26
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2017-12-25
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury Provision of informed consent

Exclusion Criteria

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative Treatment	Conservative Treatment	Standard protocol for conservative treatment will consist of the implementation of a sling and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
Operative Plate Fixation	Operative Plate Fixation	The operating surgeon will determine the positioning of the patient for surgery. ORIF of the humeral shaft fracture will be carried out

Primary Outcome Measures

Name	Time	Method
Union rate	1 year after surgery	Union rate of the fracture from X-ray

Secondary Outcome Measures

Name	Time	Method
Functional score	1 year after surgery	DASH score of the injured arm