Quadrilateral Surface Plate (QSP) Focused Registry

Completed

• Conditions: Acetabular Fracture
• Interventions: Device: Quadrilateral Surface Plate

• Registration Number: NCT01839565
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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).

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Primary Completion: 2017-03
• Study Completion: 2019-04
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Surgical treatment-related Adverse Events	Intra-operative	Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.

Secondary Outcome Measures

Name	Time	Method
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 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 24 months	post-operative	Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 24 months postoperative
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
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 3 months	post-operative	Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint: - 3 months postoperative

Trial Locations

Locations (6)

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

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Ortopedia e Traumatologia; 🇮🇹 Rome, Italy