Status:
COMPLETED
Quadrilateral Surface Plate (QSP) Focused Registry
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Acetabular Fracture
Eligibility:
All Genders
18+ years
Brief 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. Us...
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 retros...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01839565
Start Date
October 1 2012
End Date
April 1 2019
Last Update
August 13 2020
Active Locations (6)
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1
Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
Frankfurt, Germany, 60389
2
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69118
3
University of Saarland
Homburg/Saar, Germany, 66421
4
Klinikum der Johannes Gutenberg Universitaet Mainz
Mainz, Germany, 55131