This trial is active, not recruiting.

Condition fracture of posterior wall of acetabulum
Treatments w-shaped angular plate, reconstruction plate
Phase phase 4
Sponsor Hebei Medical University Third Hospital
Start date December 2014
End date March 2017
Trial size 40 participants
Trial identifier NCT02327949, HZY-0001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
WP group:treated with W-Shaped Angular Plate
w-shaped angular plate
Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate
(Active Comparator)
RP group:treated with Reconstruction Plate
reconstruction plate
Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate

Primary Outcomes

Reduction quality of fracture
time frame: Six months

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Prospective Comparison Between W-Shaped Acetabular Angular Plate (WAAP) and Reconstruction Plate for the Treatment of Posterior Acetabular Wall Fracture
Principal investigator Shuai Shang, MM
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hebei Medical University Third Hospital.