An observational study in Femoral Fractures, sponsored by Citieffe S.r.l. Status unknown at 3 sites in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2012-09-11.
Sponsored by Citieffe S.r.l · Observational
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before their surgery (retrospectively) until day 180 after surgery (retrospectively and prospectively).
This study is aimed at collecting data from patients who have already been treated with EBA2 nail. Data collection will cover the details of the fracture and surgery (from which the retrospective nature of the study), as well as details of follow up visits after surgery that patients routinely carry out up to 6 months (from which the prospective nature of the study).
The study will be conducted in three clinical sites in Italy.
EBA2, the technological evolution of Endovis BA, is now available. The device was developed in conformity with Regulations 93/42/CE and 2007/47/CE, it has the CE trademark and it is registered in the Italian National Registry of Medical Devices. EBA2 has the unique features described below:
The aim of the present observational study is to collect data that confirm for EBA2, the technological evolution of Endovis BA, the performance and tolerability proved in the previous trial. In addition, given the increasing importance that good quality of life represents in elderly, objective of this observational study is to verify the general satisfaction of the patient with lateral proximal femoral fractures treated with EBA2.
In order to evaluate subject's walking ability after the surgical insertion of EBA2, only subjects who could walk independently before of the fracture will be included in this observational study.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Citieffe S.r.l as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fracture in the period 01.08.2011 - 31.01.2012 followed by each study sites
Exclusion Criteria:
Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures
Device: EBA2
Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated
Also known as: Endovis B.A.
EBA2 performance at day 90
As a first primary endpoint, EBA2 performance will be assessed at 90 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device. Since a centralized review will be performed, the extent of agreement between raters will be assessed using both Kappa statistic and AC1-statistic. Any discrepancy on the X-ray evaluation will be discussed between the raters and possibly with the Sponsor.
Time frame: Day 90
EBA2 performance at day 180
EBA2 performance will also be assessed at 180 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device.
Time frame: Day 180
EBA2 performance at day 30 (optional primary endpoint)
EBA2 performance will be optionally assessed at 30 days. The performance will be assessed on the basis of failures, complications and malfunctioning related to the device.
Time frame: Day 30
SF12 Questionnaire
The SF12 Questionnaire routinely administered to patients, will be used to assess the subjective general satisfaction of patients treated with EBA2 at day 30 (optional), 90 and 180.
Time frame: Day 30 (optional), 90 and 180
Clinical evaluation of pain
Clinical evaluation of pain data will be collected at day 30 (optional), 90 and 180 and summarized in a 4-point scale (no pain, mild, moderate, unbearable).
Time frame: Day 30 (optional), 90 and 180
Radiographic examination
The reduction maintenance, the fracture consolidation and the callus formation will be assessed through radiographic examination at day 30 (optional), 90 and 180. Frequencies and percentages will be calculated at each time point.
Time frame: Day 30 (optional), 90 and 180
Walking ability data
Walking ability data will be collected at day 30 (optional), 90 and 180 and summarized in a 3-point scale (not walking, walking with support, walking without support).
Time frame: Day 30 (optional), 90 and 180
Device-related adverse events
Device-related adverse events reported during the study will be described using frequency and percentage and coded according to MedDRA coding (version 13). The number and percentage of subjects with at least one device-related adverse event will be showed. The frequency of events by SOC (System Organ Class) and PT (Preferred Term) will be reported. The characteristics of the events occurring to subjects (severity, duration, outcome, etc.) will also be summarized. The events will also be described by nature of device failure or malfunctioning.
Time frame: Up to day 180
This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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