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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with EBA2 | Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBA2 | Device | Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical evaluation of pain |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Caiaffa, MD | S.C. Ortopedia e Traumatologia - P.O. Centrale "SS. Annunziata" ASL Taranto - Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Consorziale Policlinico | Bari | 70124 | Italy | |||
| Unità operativa complessa di Ortopedia e Traumatologia - AUSL 12 di Viareggio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16059696 | Background | 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. doi: 10.1007/s00402-005-0021-5. | |
| 17144789 | Background | 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. doi: 10.1359/jbmr.061113. |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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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 |
| 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 |
| 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 |
| 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 |
| Lido di Camaiore |
| Italy |
| S.C. Ortopedia e Traumatologia - P.O. Centrale SS. Annunziata | Taranto | 74100 | Italy |
| 6497603 | Background | Zain Elabdien BS, Olerud S, Karlstrom G. The influence of age on the morphology of trochanteric fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):156-61. doi: 10.1007/BF00435546. |
| 2738306 | Background | Cummings SR, Nevitt MC. A hypothesis: the causes of hip fractures. J Gerontol. 1989 Jul;44(4):M107-11. doi: 10.1093/geronj/44.4.m107. |
| Background | 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 |
| 11379732 | Background | Haidukewych GJ, Israel TA, Berry DJ. Reverse obliquity fractures of the intertrochanteric region of the femur. J Bone Joint Surg Am. 2001 May;83(5):643-50. doi: 10.2106/00004623-200105000-00001. |
| 11380135 | Background | 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. |