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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrilateral Surface Plate | Device | Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical treatment-related Adverse Events | Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture. | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life | Changes in Quality of Life, pain and mobility using questionnaires (EQ-5D and Merle d'Aubigné score) | Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative |
| Fracture Healing |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative exclusion criteria:
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The increasing number of acetabular fractures in elderly individuals with osteoporosis has added new technical challenges to surgical management. A common group of fracture patterns in this population is the anterior wall or column often with an associated posterior hemitransverse.
These injuries frequently also include quadrilateral surface comminution which can make both reduction and stabilization more difficult. The 3.5 mm quadrilateral surface plate was developed to provide a more effective way to deal with these issues, for example, a way to deal with the quadrilateral surface enbloc for reduction, allowing buttress stabilization, which is independent of bone density.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Pohlemann, Prof. MD | AO foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berufsgenossenschaftliche Unfallklinik Frankfurt am Main | Frankfurt | 60389 | Germany | |||
| Universitaetsklinikum Heidelberg |
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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.
| 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) | 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 | 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 | post-operative |
| Surgical treatment-related Adverse Events till 6 months | Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 6 months postoperative | 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 | 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 | post-operative |
| Heidelberg |
| 69118 |
| Germany |
| University of Saarland | Homburg/Saar | 66421 | Germany |
| Klinikum der Johannes Gutenberg Universitaet Mainz | Mainz | 55131 | Germany |
| Ortopedia e Traumatologia | Rome | 00165 | Italy |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |