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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01839565
Other study ID # FR_QSP
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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