Quadrilateral Surface Plate (QSP) Focused Registry

August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60389
        • Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
      • Heidelberg, Germany, 69118
        • Universitaetsklinikum Heidelberg
      • Homburg/Saar, Germany, 66421
        • University of Saarland
      • Mainz, Germany, 55131
        • Klinikum Der Johannes Gutenberg Universitaet Mainz
  • Italy
      • Rome, Italy, 00165
        • Ortopedia e Traumatologia
  • Switzerland
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The increasing number of acetabular fractures in elderly individuals with osteoporosis has added new technical challenges to surgical management. A common group of fracture patterns in this population is the anterior wall or column often with an associated posterior hemitransverse.

These injuries frequently also include quadrilateral surface comminution which can make both reduction and stabilization more difficult. The 3.5 mm quadrilateral surface plate was developed to provide a more effective way to deal with these issues, for example, a way to deal with the quadrilateral surface enbloc for reduction, allowing buttress stabilization, which is independent of bone density.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate
Device: Quadrilateral Surface Plate
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical treatment-related Adverse Events
Time Frame: Intra-operative
Collection of (Serious) Adverse Events related to the surgical treatment of the acetabular fracture.
Intra-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
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.
Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative
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)
post-operative
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
post-operative
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
post-operative
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
post-operative
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
post-operative
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
post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Investigators

  • Principal Investigator: Tim Pohlemann, Prof. MD, AO Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR_QSP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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