Quadrilateral Surface Plate (QSP) Focused Registry

Acetabular Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839565
• Other study ID #: FR_QSP
• Status: Completed
• Start date: October 2012
• Est. completion date: April 2019

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2019
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

Intervention

Device:
• Quadrilateral Surface Plate
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliche Unfallklinik Frankfurt am Main	Frankfurt
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	University of Saarland	Homburg/Saar
Germany	Klinikum der Johannes Gutenberg Universitaet Mainz	Mainz
Italy	Ortopedia e Traumatologia	Rome
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical treatment-related Adverse Events	Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.	Intra-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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