Fracture of Posterior Wall of AcetabulumPhase 4NCT02327949
W-Shaped Acetabular Angular Plate (WAAP) Versus Reconstruction Plate
A Phase 4 study testing W-Shaped Angular Plate and Reconstruction Plate in people with Fracture of Posterior Wall of Acetabulum, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Posterior Wall of Acetabulum
- What is being tested?
- W-Shaped Angular Plate and Reconstruction Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Mar 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older(with no upper age limit)
- Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1)
- Operation was performed within 14 days after the fracture occurring
Who cannot join
- Presented with a pathologic acetabular fracture
- Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
- Refused to participate
- Patients who were unable to walk before injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture
The purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum.
Read the detailed description
The posterior acetabular wall fracture is one of the simpler acetabular fracture patterns and the most common type, accounting for approximately one quarter of all acetabular fractures. Most patients achieve excellent outcomes after anatomical reduction and rigid internal fixation with standard screws and buttress plates.However,it is well known that the reconstruction plate need remould in the surgery. So it does not only lead to the extension of operation time, but also cause poor attach of acetabular posterior wall. Moreover, the angulation of the screw placement for the holes of the reconstruction plate in the danger zone was determined with only caution. The intraoperative fluoroscopy was employed frequently to help determine the periacetabular screw location. If the operator lack of experience, intraarticular screw penetration and prolonged operative duration is inevitable. The investigators now introduce a new type of internal fixation device of acetabular posterior wall fracture that improve the shortcomings of existing technology.The plate itself can be thought to consist of three regions: the iliac region, the danger zone region, and the ischial tuberosity region. The organization of these regions causes the plate to resemble the English alphabet letter ''W''.The contour and zygomorphy of the W-shaped plate matched the surface of the posterior column of the acetabulum. There are two rows of drill holes in the danger zone region. A special safe-angled drilling guide was used to assist in the operation. A retrospective study has been indicated that this kind of new plate produce good results. This device may help to avoid intraarticular screw penetration and reduce operative duration and blood loss. The device further provides a stable fixation of the posterior wall that is amenable to early range of motion and weight bearing postoperatively, and results in a good clinical outcome.
- Conditions
- Fracture of Posterior Wall of Acetabulum
- Being tested
- W-Shaped Angular Plate, Reconstruction Plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W-Shaped Angular PlateDevice
Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate
Reconstruction PlateDevice
Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate
| Study group | Role | What they receive |
|---|---|---|
| WP group | Experimental | WP group:treated with W-Shaped Angular Plate Receives: Device: W-Shaped Angular Plate |
| RP group | Active comparator | RP group:treated with Reconstruction Plate Receives: Device: Reconstruction Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction quality of fracture
Based on the radiographic grade criteria developed by Matta
Measured: Six months
Secondary outcomes (4)
Surgical details
Operative duration,Fluoroscopy time,Blood loss, Blood transfusion,Any possible intraoperative complications
Measured: Intraoperative
Early postoperative complications
Deep vein thrombosis (DVT), Skin necrosis, Infection, Loss of reduction, Arthritis,Death
Measured: One month
Late postoperative complications
Heterotopic ossification, Chondrolysis, Avascular necrosis,Posttraumatic arthrosis
Measured: One year
Evaluation of Clinical outcome
According to a modified Merle d'Aubigne and Postel score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Posterior Wall of AcetabulumStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Hou, Hebei Medical University Third Hospital
- Investigators
- Zhiyong Hou, MD, Study chair, Hebei Medical University Third HospitalShuai Shang, MM, Principal investigator, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327949
- Sponsor's protocol ID
- HZY-0001
- Status last verified
- Aug 2016
- First submitted
- 20 Dec 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture
- ClinicalTrials.gov ID
- NCT02327949
- Acronym / sponsor ID
- HZY-0001
- Conditions
- Fracture of Posterior Wall of Acetabulum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 31 Dec 2014 (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 purpose of this study is to determine whether this new W-Shaped Angular Plate is more effective and more safe to operate than the traditional reconstruction plate in the treatment of the posterior wall fracture of acetabulum.
Detailed description
The posterior acetabular wall fracture is one of the simpler acetabular fracture patterns and the most common type, accounting for approximately one quarter of all acetabular fractures. Most patients achieve excellent outcomes after anatomical reduction and rigid internal fixation with standard screws and buttress plates.However,it is well known that the reconstruction plate need remould in the surgery. So it does not only lead to the extension of operation time, but also cause poor attach of acetabular posterior wall. Moreover, the angulation of the screw placement for the holes of the reconstruction plate in the danger zone was determined with only caution. The intraoperative fluoroscopy was employed frequently to help determine the periacetabular screw location. If the operator lack of experience, intraarticular screw penetration and prolonged operative duration is inevitable. The investigators now introduce a new type of internal fixation device of acetabular posterior wall fracture that improve the shortcomings of existing technology.The plate itself can be thought to consist of three regions: the iliac region, the danger zone region, and the ischial tuberosity region. The organization of these regions causes the plate to resemble the English alphabet letter ''W''.The contour and zygomorphy of the W-shaped plate matched the surface of the posterior column of the acetabulum. There are two rows of drill holes in the danger zone region. A special safe-angled drilling guide was used to assist in the operation. A retrospective study has been indicated that this kind of new plate produce good results. This device may help to avoid intraarticular screw penetration and reduce operative duration and blood loss. The device further provides a stable fixation of the posterior wall that is amenable to early range of motion and weight bearing postoperatively, and results in a good clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WP group | Experimental | Device: W-Shaped Angular PlateWP group:treated with W-Shaped Angular Plate |
| RP group | Active comparator | Device: Reconstruction PlateRP group:treated with Reconstruction Plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 years or older(with no upper age limit)
- Sustained a posterior acetabular wall fracture(ASIF/OTA classification 62-A1)
- Operation was performed within 14 days after the fracture occurring
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
- Patients who were unable to walk before injury
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 |
|---|---|---|
| W-Shaped Angular PlateTreatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate | Device | WP group |
| Reconstruction PlateTreatment of posterior wall fracture of the acetabulum with a Reconstruction Plate | Device | RP group |
Primary outcome
Reduction quality of fracture
Time frame: Six months
Based on the radiographic grade criteria developed by Matta
4 secondary outcomes
Surgical details
Time frame: Intraoperative
Early postoperative complications
Time frame: One month
Late postoperative complications
Time frame: One year
Evaluation of Clinical outcome
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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.
Zhiyong Hou, MD study chair
Hebei Medical University Third Hospital
Shuai Shang, MM principal investigator
Hebei Medical University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing W-Shaped Angular Plate and Reconstruction Plate in people with Fracture of Posterior Wall of Acetabulum, 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 3 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 17 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Reduction quality of fracture (time frame: Six 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 17 Aug 2016.