Skip to main content
OpenTrials
Completed

NCT Number: NCT01839565

Quadrilateral Surface Plate (QSP) Focused Registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acetabular Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Frankfurt, Germany

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrilateral Surface Plate

Device

Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Primary outcomes

  1. Surgical treatment-related Adverse Events

    Time frame: Intra-operative

    Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.

Secondary outcomes

  1. Changes in Quality of Life

    Time frame: 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)

  2. Fracture Healing

    Time frame: 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.

  3. Surgical treatment-related Adverse Events till discharge

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 1-12 days postoperative (till discharge)

  4. Surgical treatment-related Adverse Events till 6 weeks

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 6 weeks postoperative

  5. Surgical treatment-related Adverse Events till 3 months

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 3 months postoperative

  6. Surgical treatment-related Adverse Events till 6 months

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 6 months postoperative

  7. Surgical treatment-related Adverse Events till 12 months

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 12 months postoperative

  8. Surgical treatment-related Adverse Events till 24 months

    Time frame: post-operative

    Collection of surgery-related (Serious) Adverse Events related to surgical procedure at timepoint:

    • 24 months postoperative

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Apr 25, 2013
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.