Clinical trial NCT01599221: Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
Official title: Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Fractures
Keywords: Femoral fractures
Nail
Implant
Elderly
Orthopaedics
Lead sponsor: Citieffe S.r.l
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2012-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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

Brief summary: 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.

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 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.

Primary outcomes:
measure: EBA2 performance at day 90
timeFrame: Day 90
measure: EBA2 performance at day 180
timeFrame: Day 180
measure: EBA2 performance at day 30 (optional primary endpoint)
timeFrame: Day 30
Secondary outcomes:
measure: SF12 Questionnaire
timeFrame: Day 30 (optional), 90 and 180
measure: Clinical evaluation of pain
timeFrame: Day 30 (optional), 90 and 180
measure: Radiographic examination
timeFrame: Day 30 (optional), 90 and 180
measure: Walking ability data
timeFrame: Day 30 (optional), 90 and 180
measure: Device-related adverse events
timeFrame: Up to day 180
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico
city: Lido di Camaiore
country: Italy
facility: Unità operativa complessa di Ortopedia e Traumatologia - AUSL 12 di Viareggio
city: Taranto
country: Italy
facility: S.C. Ortopedia e Traumatologia - P.O. Centrale SS. Annunziata
Study officials:
affiliation: S.C. Ortopedia e Traumatologia - P.O. Centrale "SS. Annunziata" ASL Taranto - Italy
name: Vincenzo Caiaffa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Olsson O, Ceder L, Hauggaard A. Femoral shortening in intertrochanteric fractures. A comparison between the Medoff sliding plate and the compression hip screw. J Bone Joint Surg Br. 2001 May;83(4):572-8. doi: 10.1302/0301-620x.83b4.11302.