Calcaneus FractureNCT04070274
A New Surgery Platform for Calcaneal Surgery: a Clinical Research
A study testing different types of surgery platforms in people with Calcaneus Fracture, run by Yangzhou University.
Trial summary
Purpose: Study on the method of lateral nursing and surgical operating tables optimization in the calcaneal surgery. Method:Design combined surgical operating tables grouped according to the time of clinical application.58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and… Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- different types of surgery platforms
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2019
- 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 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ranged from 18 to 82.
- ASA Ⅰ or Ⅱ level.
Who cannot join
- Limited body activity and extremely severe cardiovascular diseases.
- Unwilling to cooperate.
- Mental illness and coagulopathy
About this study
Purpose: Study on the method of lateral nursing and surgical operating tables optimization in the calcaneal surgery.
Method:Design combined surgical operating tables grouped according to the time of clinical application.58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied to compare the sliding of the affected limb during a surgery, the stability of the position, the difference of the surgical instruments fall and the satisfaction of the medical staff.Moreover,30 healthy volunteers are selected to experience the comfort level of the two placement methods.
- Conditions
- Calcaneus Fracture
- Being tested
- different types of surgery platforms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of surgery platformsProcedure or surgery
58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied in the groups.
| Study group | Role | What they receive |
|---|---|---|
| New surgery platform for calcaneal surgery | Experimental | The lateral position surgical platform for calcaneus surgery is designed with a bottom board, mats in front and at back of calf and thigh, and two sizes of cover plates, using "tunnel" principle according to physiological curve of lower limbs. Receives: Procedure: different types of surgery platforms |
| Traditional lateral platform | Experimental | The traditional lateral position makes the surgery platform "bread-shaped arch" surface by using medical mats and putting lower limbs superimpose on each other Receives: Procedure: different types of surgery platforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sliding frequency of the affected limb during a surgery with two methods
More or fewer times
Measured: Intraoperative
The time patients'surgical position can last for in a surgery.
Necessary position stability is significant.For intraoperative fluoroscopy,surgeons need to keep the injured feet a fixing steady position with the help of different platforms.So,time the steady position can last for is recorded by the investigator separately.
Measured: Intraoperative
The frequency of the surgical instruments fall with different methods
More or fewer times
Measured: Intraoperative
The whole satisfaction level of the patients and medical staffs
Patients and medical staffs are asked for feelings about the utilization of the new surgical platform.Mark 0 is extreme poor.Mark 10 is very perfect,and the numbers between them are comments of varying degrees.
Measured: From the beginning of operation till 1 days postoperative
Secondary outcomes (1)
Extra possible adverse effects due to the new surgical platform
Check adverse effects on the basis of influences on respiratory or circulatory systems and damages on patients' nerves or skin.
Measured: From the beginning of operation till 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startJan 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FractureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070274
- Sponsor's protocol ID
- 20190810
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 30 Aug 2019
- 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 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Surgery Platform for Calcaneal Surgery: a Clinical Research
- ClinicalTrials.gov ID
- NCT04070274
- Acronym / sponsor ID
- 20190810
- Conditions
- Calcaneus Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 28 Aug 2019 (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.
Purpose: Study on the method of lateral nursing and surgical operating tables optimization in the calcaneal surgery.
Method:Design combined surgical operating tables grouped according to the time of clinical application.58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied to compare the sliding of the affected limb during a surgery, the stability of the position, the difference of the surgical instruments fall and the satisfaction of the medical staff.Moreover,30 healthy volunteers are selected to experience the comfort level of the two placement methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New surgery platform for calcaneal surgery | Experimental | Procedure: different types of surgery platformsThe lateral position surgical platform for calcaneus surgery is designed with a bottom board, mats in front and at back of calf and thigh, and two sizes of cover plates, using "tunnel" principle according to physiological curve of lower limbs. |
| Traditional lateral platform | Experimental | Procedure: different types of surgery platformsThe traditional lateral position makes the surgery platform "bread-shaped arch" surface by using medical mats and putting lower limbs superimpose on each other |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages ranged from 18 to 82.
- ASA Ⅰ or Ⅱ level.
Key exclusion criteria (3 listed)
- Limited body activity and extremely severe cardiovascular diseases.
- Unwilling to cooperate.
- Mental illness and coagulopathy
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 |
|---|---|---|
| different types of surgery platforms58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied in the groups. | Procedure or surgery | New surgery platform for calcaneal surgery, Traditional lateral platform |
Primary outcome
The sliding frequency of the affected limb during a surgery with two methods
Time frame: Intraoperative
More or fewer times
The time patients'surgical position can last for in a surgery.
Time frame: Intraoperative
Necessary position stability is significant.For intraoperative fluoroscopy,surgeons need to keep the injured feet a fixing steady position with the help of different platforms.So,time the steady position can last for is recorded by the investigator separately.
The frequency of the surgical instruments fall with different methods
Time frame: Intraoperative
More or fewer times
The whole satisfaction level of the patients and medical staffs
Time frame: From the beginning of operation till 1 days postoperative
Patients and medical staffs are asked for feelings about the utilization of the new surgical platform.Mark 0 is extreme poor.Mark 10 is very perfect,and the numbers between them are comments of varying degrees.
1 secondary outcome
Extra possible adverse effects due to the new surgical platform
Time frame: From the beginning of operation till 24 hours postoperative
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 30 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing different types of surgery platforms in people with Calcaneus Fracture, run by Yangzhou University.
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 2 inclusion and 3 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 sliding frequency of the affected limb during a surgery with two methods (time frame: Intraoperative). The study lists 4 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 30 Aug 2019.