Quadrilateral Surface Plate (QSP) Focused Registry

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Acetabular Fracture

Treatments: Device: Quadrilateral Surface Plate

Study type: Observational

Funder types: Other

Identifiers

NCT01839565

FR_QSP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Patients

Description:

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

Treatment:

Device: Quadrilateral Surface Plate