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.
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).
Study Type
OBSERVATIONAL
Enrollment
13
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate
Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
Frankfurt, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
University of Saarland
Homburg/Saar, Germany
Klinikum der Johannes Gutenberg Universitaet Mainz
Mainz, Germany
Surgical treatment-related Adverse Events
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
Time frame: Intra-operative
Changes in Quality of Life
Changes in Quality of Life, pain and mobility using questionnaires (EQ-5D and Merle d'Aubigné score)
Time frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Fracture Healing
Fracture healing: defined as a fracture radiographically showing at least three cortices with signs of callus or trabeculae crossing from one side of the fracture to the other.
Time frame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
Surgical treatment-related Adverse Events till discharge
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 1-12 days postoperative (till discharge)
Time frame: post-operative
Surgical treatment-related Adverse Events till 6 weeks
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 6 weeks postoperative
Time frame: post-operative
Surgical treatment-related Adverse Events till 3 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 3 months postoperative
Time frame: post-operative
Surgical treatment-related Adverse Events till 6 months
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Ortopedia e Traumatologia
Rome, Italy
Luzerner Kantonsspital
Lucerne, Switzerland
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 6 months postoperative
Time frame: post-operative
Surgical treatment-related Adverse Events till 12 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 12 months postoperative
Time frame: post-operative
Surgical treatment-related Adverse Events till 24 months
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: \- 24 months postoperative
Time frame: post-operative