ClinicalTrials.gg
Status unknownNCT03358173Updated Nov 30, 2017

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

An observational study in Humeral Fractures, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-30.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Humeral Fractures

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Keywords

  • Humeral Fractures
  • plate
  • Conservative Treatment
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In context

Humeral Fractures

106 studies on the registry are indexed under Humeral Fractures; 20 are open to participants now.

This study's planned enrollment of 52 is below the median of 91 across 36 observational studies indexed under Humeral Fractures.

Browse Humeral Fractures studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 due to significant medical co-morbidity Medical 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.)

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Conservative Treatment

  • 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

    Procedure: Operative Plate Fixation

Interventions

  • ProcedureConservative Treatment

    Conservative Treatment

  • ProcedureOperative Plate Fixation

    Operative Plate Fixation

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What researchers measure

Primary outcomes

  1. Union rate

    Union rate of the fracture from X-ray

    Time frame: 1 year after surgery

Secondary outcomes

  1. Functional score

    DASH score of the injured arm

    Time frame: 1 year after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2017; primary completion for Jun 2018, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2017
First posted
Nov 30, 2017
StartEst.
Dec 25, 2017
Primary completionEst.
Jun 1, 2018
CompletionEst.
Jun 1, 2018
Last update
Nov 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03358173
Responsible party
pengzhang (Department of orthopaedics and trauma, Peking University People's Hospital) — Principal investigator
First posted
Nov 30, 2017
Start date
Dec 25, 2017 (estimated)
Primary completion
Jun 1, 2018 (estimated)
Completion
Jun 1, 2018 (estimated)
Last update
Nov 30, 2017

Study contacts

yichong zhang, MD
Contact
875274428@qq.com
15210802766
Peng Zhang, MD
principal investigator · Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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