Fracture DislocationNCT03026868
Novel Quadrilateral Surface Plate for Acetabular Fracture
A study testing quadrilateral surface plate in people with Fracture Dislocation, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture Dislocation
- What is being tested?
- quadrilateral surface plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Fracture involving quadrilateral surface
- Operation was conducted within 14 days
- Fixed with quadrilateral surface plate through Stoppa approach
Who cannot join
- Presented with a pathologic acetabular fracture
- Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
- Refused to participate
- Follow-up insufficient 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiyong Hou
Shijiazhuang, Hebei, 050051
Zhiyong Hou, M.D, +8618533112800, houzhiyong1234@126.com
Ruipeng Zhang, M.D
About this study
Official title: Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface
The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.
Read the detailed description
Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.
- Conditions
- Fracture Dislocation
- Being tested
- quadrilateral surface plate
- Keywords
- acetabular, quadrilateral surface plate
- Medical subject headings
- Fracture Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrilateral surface plateProcedure or surgery
Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.
| Study group | Role | What they receive |
|---|---|---|
| quadrilateral surface plate | Experimental | The fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach. Receives: Procedure: quadrilateral surface plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture healing time
fracture line disappeared in the radiograph
Measured: 4 months
Secondary outcomes (1)
complication
wound infection, iatrogenic injury of vessels and nerves, nonunion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture DislocationStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruipeng Zhang, M.D, Principal investigator, Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026868
- Sponsor's protocol ID
- HZY2016
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trails of Different Fixations for Acetabular Fracture Involving Quadrilateral Surface
- ClinicalTrials.gov ID
- NCT03026868
- Acronym / sponsor ID
- HZY2016
- Conditions
- Fracture Dislocation
- Keywords
- acetabular, quadrilateral surface plate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- 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 novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.
Detailed description
Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quadrilateral surface plate | Experimental | Procedure: quadrilateral surface plateThe fragments of the acetabulum were fixed with novel quadrilateral surface plate through Stoppa approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Fracture involving quadrilateral surface
- Operation was conducted within 14 days
- Fixed with quadrilateral surface plate through Stoppa approach
Key exclusion criteria (4 listed)
- Presented with a pathologic acetabular fracture
- Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
- Refused to participate
- Follow-up insufficient 12 months
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 |
|---|---|---|
| quadrilateral surface plateBoth anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach. | Procedure or surgery | quadrilateral surface plate |
Primary outcome
fracture healing time
Time frame: 4 months
fracture line disappeared in the radiograph
1 secondary outcome
complication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Ruipeng Zhang, M.D principal investigator
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quadrilateral surface plate in people with Fracture Dislocation, run by Hebei Medical University Third Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Hou, M.D (+8618533112800, houzhiyong1234@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fracture healing time (time frame: 4 months). 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 15 Dec 2017.