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NCT03358173 Clinical Trial

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

Humeral Fractures Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03358173
Other study ID # csg-ggggz
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2017
Last updated November 26, 2017
Start date December 25, 2017
Est. completion date June 1, 2018

Study information
Verified date November 2017
Source Peking University People's Hospital
Contact yichong zhang, MD
Phone 15210802766
Email 875274428@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 52
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Conservative Treatment
Conservative Treatment
• Operative Plate Fixation
Operative Plate Fixation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Union rate Union rate of the fracture from X-ray 1 year after surgery
Secondary Functional score DASH score of the injured arm 1 year after surgery
See also
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