NCT01839565

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

4.4 years

First QC Date

April 12, 2013

Last Update Submit

August 11, 2020

Conditions

Acetabular Fracture

Keywords

Adverse eventsOsteosynthesisQuality of life

Outcome Measures

Primary Outcomes (1)

  • Surgical treatment-related Adverse Events

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

    Intra-operative

Secondary Outcomes (8)

  • Changes in Quality of Life

    Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative

  • Fracture Healing

    Post-op till Hospital Discharge; 6 weeks; 3, 6, 12 and 24 months post-operative

  • Surgical treatment-related Adverse Events till discharge

    post-operative

  • Surgical treatment-related Adverse Events till 6 weeks

    post-operative

  • Surgical treatment-related Adverse Events till 3 months

    post-operative

  • +3 more secondary outcomes

Study Arms (1)

Patients

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

Device: Quadrilateral Surface Plate

Interventions

Quadrilateral Surface PlateDEVICE

Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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 decision to use implants other than the device under investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Berufsgenossenschaftliche Unfallklinik Frankfurt am Main

Frankfurt, 60389, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69118, Germany

Location

University of Saarland

Homburg/Saar, 66421, Germany

Location

Klinikum der Johannes Gutenberg Universitaet Mainz

Mainz, 55131, Germany

Location

Ortopedia e Traumatologia

Rome, 00165, Italy

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Study Officials

  • Tim Pohlemann, Prof. MD

    AO foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 25, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2017

Study Completion

April 1, 2019

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

IT(1)CH(1)DE(4)