Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft
1 other identifier
observational
52
0 countries
N/A
Brief Summary
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2017
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
December 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedNovember 30, 2017
November 1, 2017
5 months
November 26, 2017
November 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Union rate
Union rate of the fracture from X-ray
1 year after surgery
Secondary Outcomes (1)
Functional score
1 year after surgery
Study Arms (2)
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
The operating surgeon will determine the positioning of the patient for surgery. ORIF of the humeral shaft fracture will be carried out
Interventions
Eligibility 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
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peng Zhang, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of orthopaedics and trauma
Study Record Dates
First Submitted
November 26, 2017
First Posted
November 30, 2017
Study Start
December 25, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
November 30, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share