Quadrilateral Surface Plate (QSP) Focused Registry
Study Details
Study Description
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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate |
Device: Quadrilateral Surface Plate
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate
|
Outcome Measures
Primary Outcome Measures
- Surgical treatment-related Adverse Events [Intra-operative]
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
Secondary Outcome Measures
- Changes in Quality of Life [Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative]
Changes in Quality of Life, pain and mobility using questionnaires (EQ-5D and Merle d'Aubigné score)
- Fracture Healing [Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative]
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.
- Surgical treatment-related Adverse Events till discharge [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 1-12 days postoperative (till discharge)
- Surgical treatment-related Adverse Events till 6 weeks [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 6 weeks postoperative
- Surgical treatment-related Adverse Events till 3 months [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 3 months postoperative
- Surgical treatment-related Adverse Events till 6 months [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 6 months postoperative
- Surgical treatment-related Adverse Events till 12 months [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 12 months postoperative
- Surgical treatment-related Adverse Events till 24 months [post-operative]
Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 24 months postoperative
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | |
| 5 | Ortopedia e Traumatologia | Rome | Italy | 00165 | |
| 6 | Luzerner Kantonsspital | Luzern | Switzerland | 6000 |
Sponsors and Collaborators
- AO Clinical Investigation and Publishing Documentation
Investigators
- Principal Investigator: Tim Pohlemann, Prof. MD, AO foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FR_QSP