Clinical trial NCT01839565: Quadrilateral Surface Plate (QSP) Focused Registry
Official title: A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Keywords: Adverse events
Osteosynthesis
Quality of life
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Surgical treatment-related Adverse Events
timeFrame: Intra-operative
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
measure: Fracture Healing
timeFrame: Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
measure: Surgical treatment-related Adverse Events till discharge
timeFrame: post-operative
measure: Surgical treatment-related Adverse Events till 6 weeks
timeFrame: post-operative
measure: Surgical treatment-related Adverse Events till 3 months
timeFrame: post-operative
measure: Surgical treatment-related Adverse Events till 6 months
timeFrame: post-operative
measure: Surgical treatment-related Adverse Events till 12 months
timeFrame: post-operative
measure: Surgical treatment-related Adverse Events till 24 months
timeFrame: post-operative
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: University of Saarland
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg Universitaet Mainz
city: Rome
country: Italy
facility: Ortopedia e Traumatologia
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: AO foundation
name: Tim Pohlemann, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: