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

NCT01599221 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2012-09-11

No results posted yet for this study

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.

Conditions

  • Femoral Fractures

Interventions

DEVICE

EBA2

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

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Citieffe S.r.l

    lead INDUSTRY

Principal Investigators

  • Vincenzo Caiaffa, MD · S.C. Ortopedia e Traumatologia - P.O. Centrale "SS. Annunziata" ASL Taranto - Italy

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599221 on ClinicalTrials.gov