Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Citieffe S.r.l.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Opera Srl
Information provided by (Responsible Party):
Citieffe S.r.l
ClinicalTrials.gov Identifier:
NCT01599221
First received: May 9, 2012
Last updated: September 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Femoral Fractures
Device: EBA2

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2

Resource links provided by NLM:


Further study details as provided by Citieffe S.r.l:

Primary Outcome Measures:
  • EBA2 performance at day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

    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.


  • EBA2 performance at day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    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.

  • EBA2 performance at day 30 (optional primary endpoint) [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • SF12 Questionnaire [ Time Frame: Day 30 (optional), 90 and 180 ] [ Designated as safety issue: No ]
    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.

  • Clinical evaluation of pain [ Time Frame: Day 30 (optional), 90 and 180 ] [ Designated as safety issue: No ]
    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).

  • Radiographic examination [ Time Frame: Day 30 (optional), 90 and 180 ] [ Designated as safety issue: No ]
    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.

  • Walking ability data [ Time Frame: Day 30 (optional), 90 and 180 ] [ Designated as safety issue: No ]
    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).

  • Device-related adverse events [ Time Frame: Up to day 180 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with EBA2
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
Other Name: Endovis B.A.

Detailed Description:

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:

  • it is undersized compared to other nails in commerce, both proximal and distal, to further facilitate the insertion into the bone. The undersizing is aimed to reduce the stiffness of the stem. In particular, the biological nail-bone interaction will be improved as a consequence of lower shear stresses on the frontal plane;
  • it is made entirely of titanium. The choice of such a material is aimed to create a flexible means of synthesis that minimizes the differences with the healthy bone mechanical properties and reduces complications in the process of fracture healing;
  • it is a dual-lag screw system that provides appropriate guidance to the sliding of the fractured extremities and an improved stability. It is effective to limit torsional instability of the femoral head, both during the intervention, by the action of tightening of the screw itself, and during the healing period due to improved bearing capacity towards multidirectional loads;
  • the associated surgical instruments are simple; the low number of pieces and their ease of use made the success even of the previous version.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Subjects of both genders, aged ≥ 60;
  • Subjects with diagnosed lateral proximal femoral fractures who have undergone surgery with EBA2 nail;
  • Subjects with type 31A1, 31A2 or 31A3 fractures;
  • Subjects able to walk independently (with or without walking aids) before the fracture;
  • Subjects who sustained a low energy injury within 72 h prior the surgery;
  • Subjects who received a perioperative antibiotic therapy;
  • Subjects who received antithrombotic prophylaxis for 5 weeks;
  • Subjects who underwent rehabilitation procedure for 30 days at least;
  • Subjects who have been mobilized in the 2nd operation day;
  • Subjects able to attend the scheduled visits and to follow the instructions given by the physician;
  • Subjects who have given their written informed consent.

Exclusion Criteria:

  • Subjects with rheumatoid arthritis;
  • Subjects with fractures due to metastasis;
  • Subjects with fractures operated 72 h after the traumatic event;
  • Subjects with previous ipsilateral hip or femur surgery;
  • Subjects with ASA Physical Status Classification Class 5;
  • Subjects with Karnofsky performance status scale before fracture ˂ 80;
  • Subjects who have shown hypersensitivity to any of the components of EBA2;
  • Concomitant use of any other surgical device for the femoral fracture.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599221

Locations
Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico
Bari, Italy, 70124
Unità operativa complessa di Ortopedia e Traumatologia - AUSL 12 di Viareggio
Lido di Camaiore, Italy
S.C. Ortopedia e Traumatologia - P.O. Centrale SS. Annunziata
Taranto, Italy, 74100
Sponsors and Collaborators
Citieffe S.r.l
Opera Srl
Investigators
Principal Investigator: Vincenzo Caiaffa, MD S.C. Ortopedia e Traumatologia - P.O. Centrale "SS. Annunziata" ASL Taranto - Italy
  More Information

Publications:
Responsible Party: Citieffe S.r.l
ClinicalTrials.gov Identifier: NCT01599221     History of Changes
Other Study ID Numbers: EBA2
Study First Received: May 9, 2012
Last Updated: September 10, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Citieffe S.r.l:
Femoral fractures
Nail
Implant
Elderly
Orthopaedics

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 21, 2014