ClinicalTrials.gg
Not yet recruitingNCT05758870Updated Mar 8, 2023

A Prospective Randomized Controlled Study Comparing the Clinical Effects of Surgical and Non-surgical Treatment of Low Rib Fractures

An observational study in Rib Fracture Multiple, sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.

02

Conditions studied

  • Rib Fracture Multiple
03

In context

Fractures, Multiple

14 studies on the registry are indexed under Fractures, Multiple; 4 are open to participants now.

Browse Fractures, Multiple studies →

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patient with multiple rib fractures combines with low rib fractures

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

  • Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital \< 24 hours Age 18-70 I-II Preoperative arterial oxygen partial pressure >60mmHg, carbon dioxide partial pressure \<50mmHg The participate is volunteer in the study and sign the Pain score( Number Rating Scale, NRS) >5 under calm breathing

Exclusion criteria

Exclusion Criteria:

  • Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Pregnant women
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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Groups and cohorts

  • Research Group

    surgical stabilization of low rib fracures by internal fixation

    Procedure: surgical stabilization of low rib fratures

  • Controls Group

    conservative treatment of low rib fractures

    Other: converstive treatment of low rib fratures

Interventions

  • Proceduresurgical stabilization of low rib fratures

    surgical stabiliazation of rib fractures by internal fixation

  • Otherconverstive treatment of low rib fratures

    chest wall fixation band

06

What researchers measure

Primary outcomes

  1. EQ-5D-5L

    appraisal of life quality

    Time frame: On the day of admission

  2. EQ-5D-5L

    appraisal of life quality

    Time frame: 1 week after treatment

  3. EQ-5D-5L

    appraisal of life quality

    Time frame: 2 weeks after treatment

  4. EQ-5D-5L

    appraisal of life quality

    Time frame: 1 month after treatment

  5. EQ-5D-5L

    appraisal of life quality

    Time frame: 3 months after treatment

  6. EQ-5D-5L

    appraisal of life quality

    Time frame: 6 months after treatment

Secondary outcomes

  1. Pain Score

    Number Rating Score, NRS

    Time frame: On the day of admission

  2. Pain Score

    Number Rating Score, NRS

    Time frame: 1 week after treatment

  3. Pain Score

    Number Rating Score, NRS

    Time frame: 2 weeks after treanment

  4. Pain Score

    Number Rating Score, NRS

    Time frame: 1 month after treatment

  5. Pain Score

    Number Rating Score, NRS

    Time frame: 3 months after treatment

  6. Pain Score

    Number Rating Score, NRS

    Time frame: 6 months after treatment

Other outcomes

  1. Atelectasis

    CT scan show

    Time frame: On the day of admission

  2. Atelectasis

    CT scan show

    Time frame: 1 week after treatment

  3. Atelectasis

    CT scan show

    Time frame: 2 weeks after treanment

  4. Atelectasis

    CT scan show

    Time frame: 1 month after treatment

  5. Atelectasis

    CT scan show

    Time frame: 3 months after treatment

  6. Atelectasis

    CT scan show

    Time frame: 6 months after treatment

  7. Pleural effusion

    CT scan show

    Time frame: On the day of admission

  8. Pleural effusion

    CT scan show

    Time frame: 1 week after treatment

  9. Pleural effusion

    CT scan show

    Time frame: 2 weeks after treanment

  10. Pleural effusion

    CT scan show

    Time frame: 1 months after treatment

  11. Pleural effusion

    CT scan show

    Time frame: 3 months after treatment

  12. Pleural effusion

    CT scan show

    Time frame: 6 months after treatment

  13. Mortality

    death toll in each group

    Time frame: On the day of admission

  14. Mortality

    death toll in each group

    Time frame: 1 week after treatment

  15. Mortality

    death toll in each group

    Time frame: 2 weeks after treanment

  16. Mortality

    death toll in each group

    Time frame: 1 month after treatment

  17. Mortality

    death toll in each group

    Time frame: 3 months after treatment

  18. Mortality

    death toll in each group

    Time frame: 6 months after treatment

  19. Length of hospital stay

    time of hospitalization

    Time frame: the day from in the hospital to discharge

  20. Cost of treatment

    total cost of hospitalization expense

    Time frame: the day from in the hospital to discharge

  21. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: On the day of admission

  22. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: 1 week after treatment

  23. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: 2 weeks after treanment

  24. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: 1 month after treatment

  25. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: 3 months after treatment

  26. Chest discomfort

    chest tightness, foreign body sensation, numbness of surgical incision

    Time frame: 6 months after treatment

  27. Chronic pain

    pain for more than three months after surgery or trauma, NRS assessment

    Time frame: 3 months after treatment , 6 month after treatment

  28. Chronic pain

    pain for more than three months after surgery or trauma, NRS assessment

    Time frame: 6 months after treatment

  29. Duration of analgesic drug

    the time of analgesic usement from first treat to the paitent do not use it anymore

    Time frame: the time of analgesic usement from first treat to the paitent do not use it anymore

  30. Total analgesic drug use

    total amont of analgesic usement from first treat to the paitent do not use it anymore

    Time frame: the time of analgesic usement from first treat to the paitent do not use it anymore

  31. Lung function 1

    Forced vital capacity, FVC

    Time frame: On the day of admission

  32. Lung function 1

    Forced vital capacity, FVC

    Time frame: 1 week after treatment

  33. Lung function 1

    Forced vital capacity, FVC

    Time frame: 2 weeks after treanment

  34. Lung function 1

    Forced vital capacity, FVC

    Time frame: 1 month after treatment

  35. Lung function 1

    Forced vital capacity, FVC

    Time frame: 3 months after treatment

  36. Lung function 1

    Forced vital capacity, FVC

    Time frame: 6 months after treatment

  37. Lung function 2

    First second forced vital capacity,FEV1

    Time frame: On the day of admission

  38. Lung function 2

    First second forced vital capacity, FEV1

    Time frame: 1 week after treatment

  39. Lung function 2

    First second forced vital capacity, FEV1

    Time frame: 2 weeks after treanment

  40. Lung function 2

    First second forced vital capacity, FEV1

    Time frame: 1 month after treatment

  41. Lung function 2

    First second forced vital capacity, FEV1

    Time frame: 3 months after treatment

  42. Lung function 2

    First second forced vital capacity, FEV1

    Time frame: 6 months after treatment

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2023; primary completion for Dec 2025, 32 months later.

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

Registered
Feb 11, 2023
First posted
Mar 8, 2023
StartEst.
Apr 1, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Mar 8, 2023
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 Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05758870
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Responsible party
Wu Weiming (Thoracic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital) — Principal investigator
First posted
Mar 8, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 8, 2023

Study contacts

Weiming Wu
Contact
wuweiming0427@163.com
18930172451

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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