Overview

This trial is active, not recruiting.

Condition acetabular fracture
Treatment quadrilateral surface plate
Sponsor AO Clinical Investigation and Documentation
Start date October 2012
End date September 2017
Trial size 13 participants
Trial identifier NCT01839565, FR_QSP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients undergoing osteosynthesis of acetabular fractures by using the Quadrilateral Surface Plate
quadrilateral surface plate
Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate

Primary Outcomes

Measure
Surgical treatment-related Adverse Events
time frame: Intra-operative

Secondary Outcomes

Measure
Changes in Quality of Life
time frame: 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
Surgical treatment-related Adverse Events till discharge
time frame: post-operative
Surgical treatment-related Adverse Events till 6 weeks
time frame: post-operative
Surgical treatment-related Adverse Events till 3 months
time frame: post-operative
Surgical treatment-related Adverse Events till 6 months
time frame: post-operative
Surgical treatment-related Adverse Events till 12 months
time frame: post-operative
Surgical treatment-related Adverse Events till 24 months
time frame: post-operative

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective and Retrospective Multicenter Registry for Surgeon-based Evaluation of the "Quadrilateral Surface Plate" Used for Acetabular Fractures
Principal investigator Tim Pohlemann, Prof. MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.