NCT01839565

Quadrilateral Surface Plate (QSP) Focused Registry

A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The absence of methodologically, prospectively and retrospectively collected information on the use of the Quadrilateral Surface Plate (QSP) in the given indication requires a multicenter approach. Using a registry to get more information about the effectiveness and possible benefits or complications during the surgery and during the post-operative treatment is adequate and necessary to get new insights to the use of the Quadrilateral Surface Plate.

Detailed description

This registry includes six visits at which data is collected form the patinet (pre-op, post-op, 6 weeks FU, 3 months FU, 6 months FU and 12 months FU). Patients can be inlucded prospectively or retrospectively. If properatively recruited patients complete two questionnaires (EQ5D and Merle d'Aubigné) at their preoperative visits. These questionnaires are repeated after 6 and 12 months. Surgeons report about the success of the surgical procedure in a specifically designed questionnaire. During the whole study period, adverse events related to the implant or surgery are collected as well as x-rays and CT (as per standard of care).

Conditions

• Acetabular Fracture

Interventions

Type	Name	Description
DEVICE	Quadrilateral Surface Plate	Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-03-01
• Completion: 2019-04-01
• First posted: 2013-04-25
• Last updated: 2020-08-13

Locations

6 sites across 3 countries: Germany, Italy, Switzerland