Quadrilateral Surface Plate (QSP) Focused Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the Quadrilateral Surface Plate Used for Acetabular Fractures

Conditions
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Acetabular Fracture

Intervention / Treatment
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* Device: Quadrilateral Surface Plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate | Device: Quadrilateral Surface Plate<br>* Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteosynthesis, Adverse events, Quality of life