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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

China1 site
  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 050000

Other trials in China

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.

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 groups in NCT02327949
Study groupRoleWhat they receive
WP groupExperimentalWP group:treated with W-Shaped Angular Plate
Receives: Device: W-Shaped Angular Plate
RP groupActive comparatorRP 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.

  1. Reduction quality of fracture

    Based on the radiographic grade criteria developed by Matta

    Measured: Six months

Secondary outcomes (4)
  1. Surgical details

    Operative duration,Fluoroscopy time,Blood loss, Blood transfusion,Any possible intraoperative complications

    Measured: Intraoperative

  2. Early postoperative complications

    Deep vein thrombosis (DVT), Skin necrosis, Infection, Loss of reduction, Arthritis,Death

    Measured: One month

  3. Late postoperative complications

    Heterotopic ossification, Chondrolysis, Avascular necrosis,Posttraumatic arthrosis

    Measured: One year

  4. 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.

  1. First posted31 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

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)
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

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.

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