Quadrilateral Surface Plate (QSP) Focused Registry

NCT ID: NCT01839565

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2019-04-30

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).

Conditions

Acetabular Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate

Quadrilateral Surface Plate

Intervention Type: DEVICE

Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Interventions

Quadrilateral Surface Plate

Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Intervention Type: DEVICE

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 decision to use implants other than the device under investigation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Pohlemann, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

AO foundation

Locations

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

Ortopedia e Traumatologia

Rome, , Italy

Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Germany; Italy; Switzerland

Other Identifiers

FR_QSP

Identifier Type: -

Identifier Source: org_study_id