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

Femoral Fractures Clinical Trial

Official title:

Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01599221
• Other study ID #: EBA2
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2012
• Last updated: September 10, 2012
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: May 2012
• Source: Citieffe S.r.l
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• EBA2
Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Consorziale Policlinico	Bari
Italy	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

Sponsors (2)

Lead Sponsor	Collaborator
Citieffe S.r.l	Opera Srl

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. — View Citation

Caiaffa V, De Vita D, Laforgia R, Sessa G, Varsalona R, Girolami M, Dallari D, Mignani G, Turi G, Micaglio A, et al. Treatment of peritrochanteric fractures with the Endovis BA cephalomedullary nail: multicenter study of 1091 patients Journal of Orthopaedics and Traumatology 8(3): 111-116, 2007

Cummings SR, Nevitt MC. A hypothesis: the causes of hip fractures. J Gerontol. 1989 Jul;44(4):M107-11. — View Citation

Haidukewych GJ, Israel TA, Berry DJ. Reverse obliquity fractures of the intertrochanteric region of the femur. J Bone Joint Surg Am. 2001 May;83-A(5):643-50. — View 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. — View Citation

Papasimos S, Koutsojannis CM, Panagopoulos A, Megas P, Lambiris E. A randomised comparison of AMBI, TGN and PFN for treatment of unstable trochanteric fractures. Arch Orthop Trauma Surg. 2005 Sep;125(7):462-8. — View Citation

Zain Elabdien BS, Olerud S, Karlström G. The influence of age on the morphology of trochanteric fracture. Arch Orthop Trauma Surg. 1984;103(3):156-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 90	No
Primary	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.	Day 180	No
Primary	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.	Day 30	No
Secondary	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.	Day 30 (optional), 90 and 180	No
Secondary	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).	Day 30 (optional), 90 and 180	No
Secondary	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.	Day 30 (optional), 90 and 180	No
Secondary	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).	Day 30 (optional), 90 and 180	No
Secondary	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.	Up to day 180	Yes