Rib FracturesNCT05340517
Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
A study testing video-assisted rib planting in people with Rib Fractures and Rib Fracture Multiple, run by Weigang Zhao at 1 site in China.
Trial summary
The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rib Fractures, Rib Fracture Multiple
- What is being tested?
- video-assisted rib planting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2021to 6 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥3 unilateral rib displacement fractures
- 18-70 years old
- ASA score I-II
- Preoperative arterial oxygen partial pressure >60mmHg
- Carbon dioxide partial pressure <50mmHg
Who cannot join
- The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
- Airway stenosis
- Abnormal coagulation system
- History of peptic ulcer or bleeding
- History of allergy to anesthesia related drugs
- History of asthma or chronic obstructive pulmonary emphysema
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai
About this study
The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization.
The investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Being tested
- video-assisted rib planting
- Keywords
- internal fixation, video-assisted, chest wall stabilization, prospective study
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-assisted rib plantingProcedure or surgery
Also called video-assisted thoracoscopic surgery for rib fractures
Give the patient intercostal nerve block and laryngeal mask anesthesia, after that, put the patient in lateral position. Make a 4-6cm posterolateral incision along the lower edge of the scapula，sever latissimus dorsi and serratus anterior and reach the rib surface. Lift the scapula with the abdominal retractor (or xiphoid retractor), Free adhesion tissue inside the scapula and put in the thoracoscopic lens. Free the tissue of the upper and lower edges of the ribs carefully, reset ribs and insert rib plate, which is fixed by 90° electric drill and locking screw.
| Study group | Role | What they receive |
|---|---|---|
| video-assisted rib planting | Experimental | Not described Receives: Procedure: video-assisted rib planting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS)，which is used to evaluate pain scores 6h,12h,and 24h after the operation.
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Measured: 6 hours after operation
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Measured: 12 hours after operation
The pain score after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS).
0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
Measured: 24 hours after operation
Secondary outcomes (1)
The postoperative drainage
The investigators record the postoperative drainage of patients.The drainage of chest catheter or negative pressure ball was recorded by the nurse every day after surgery.
Less postoperative drainage means faster recovery and shorter discharge times.
Measured: 7 days at most
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start22 Feb 2021
- Primary completion30 Apr 2021
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weigang Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weigang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Weigang Zhao, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340517
- Sponsor's protocol ID
- ZWG20210222
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Video-assisted Rib Planting in Chest Wall Stabilization
- ClinicalTrials.gov ID
- NCT05340517
- Acronym / sponsor ID
- ZWG20210222
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Keywords
- internal fixation, video-assisted, chest wall stabilization, prospective study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Weigang ZhaoUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization.
The investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video-assisted rib planting | Experimental | Procedure: video-assisted rib planting |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -≥3 unilateral rib displacement fractures
- 18-70 years old
- ASA score I-II
- Preoperative arterial oxygen partial pressure >60mmHg
- Carbon dioxide partial pressure <50mmHg
Key exclusion criteria (7 listed)
- The distance from the broken end of the posterior rib fracture to the spine is less than 2cm
- Airway stenosis
- Abnormal coagulation system
- History of peptic ulcer or bleeding
- History of allergy to anesthesia related drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video-assisted rib plantingAlso: video-assisted thoracoscopic surgery for rib fracturesGive the patient intercostal nerve block and laryngeal mask anesthesia, after that, put the patient in lateral position. Make a 4-6cm posterolateral incision along the lower edge of the scapula，sever latissimus dorsi and serratus anterior and reach the rib surface. Lift the scapula with the abdominal retractor (or xiphoid retractor), Free adhesion tissue inside the scapula and put in the thoracoscopic lens. Free the tissue of the upper and lower edges of the ribs carefully, reset ribs and insert rib plate, which is fixed by 90° electric drill and locking screw. | Procedure or surgery | video-assisted rib planting |
Primary outcome
The pain score after operation
Time frame: 6 hours after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS)，which is used to evaluate pain scores 6h,12h,and 24h after the operation. 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
The pain score after operation
Time frame: 12 hours after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS). 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
The pain score after operation
Time frame: 24 hours after operation
The investigators evaluate and record the patients' pain score after operation by visual analog scale (VAS). 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain.
1 secondary outcome
The postoperative drainage
Time frame: 7 days at most
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weigang Zhao principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video-assisted rib planting in people with Rib Fractures and Rib Fracture Multiple, run by Weigang Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain score after operation (time frame: 6 hours after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.