A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
Device Data
Collected from today forward - ProspectiveCase-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Age 18 years or older Diagnosis of acetabular fracture requiring surgical fixation Ability to understand the content of the patient information / informed consent form Signed and dated IRB/EC-approved written informed consent Exclusion Criteria: Any not medically managed severe systemic disease Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Prisoner Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry Intraoperative exclusion criteria: Intraoperative decision to use implants other than the device under investigation
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
Frankfurt, GermanyOpen Berufsgenossenschaftliche Unfallklinik Frankfurt am Main in Google MapsUniversitaetsklinikum Heidelberg
Heidelberg, GermanyUniversity of Saarland
Homburg/Saar, GermanyKlinikum der Johannes Gutenberg Universitaet Mainz
Mainz, Germany