Femoral FracturesNCT01599221

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

An observational study of Femoral Fractures, run by Citieffe S.r.l at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Femoral Fractures
What is being tested?: EBA2
Type of treatment: Medical device
How many people: 40 participants
Where: 3 sitesItaly
Study dates: Mar 2012to Oct 2012
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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;

Show all 11Show fewer

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

Azienda Ospedaliero-Universitaria Consorziale Policlinico
Bari, 70124
Unità operativa complessa di Ortopedia e Traumatologia - AUSL 12 di Viareggio
Lido di Camaiore
S.C. Ortopedia e Traumatologia - P.O. Centrale SS. Annunziata
Taranto, 74100

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions: Femoral Fractures
Being tested: EBA2
Keywords: Femoral fractures, Nail, Implant, Elderly, Orthopaedics
Medical subject headings: Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EBA2Device
Also called Endovis B.A.
Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated

Study groups in NCT01599221
Study group	Role	What they receive
Subjects with EBA2		Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures Receives: Device: EBA2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Day 30

Secondary outcomes (5)

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.
Measured: Day 30 (optional), 90 and 180
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Oct 2012

First posted15 May 2012 (estimated)
Study startMar 2012
Primary completionJul 2012
Study completionOct 2012 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Femoral FracturesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01599221
Sponsor's protocol ID: EBA2
Status last verified: May 2012
First submitted: 9 May 2012
Last updated: 11 Sep 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 16059696
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.
PubMed 17144789
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.
PubMed 6497603
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.
PubMed 2738306
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
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.
PubMed 11379732
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.
PubMed 11380135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Femoral Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Retrospective and Prospective Study on the Treatment of Lateral Proximal Femoral Fractures With Medical Device EBA2
ClinicalTrials.gov ID: NCT01599221
Acronym / sponsor ID: EBA2
Conditions: Femoral Fractures
Keywords: Femoral fractures, Nail, Implant, Elderly, Orthopaedics
Study type: Observational
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Citieffe S.r.lIndustry (pharma, biotech, devices)
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: Mar 2012
Primary completion: Jul 2012 (actual)
Study completion: Oct 2012 (estimated)
First posted: 15 May 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will be conducted in three clinical sites in Italy.

Detailed description

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.

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.

Study design

Observational model: Cohort
Number of arms: 1

Arm	Type	Receives
Subjects with EBA2	–	Device: EBA2Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EBA2Also: Endovis B.A.Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated	Device	Subjects with EBA2

Primary outcome

EBA2 performance at day 90
Time frame: 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.
EBA2 performance at day 180
Time frame: 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.
EBA2 performance at day 30 (optional primary endpoint)
Time frame: Day 30
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.

5 secondary outcomes

SF12 Questionnaire
Time frame: Day 30 (optional), 90 and 180
Clinical evaluation of pain
Time frame: Day 30 (optional), 90 and 180
Radiographic examination
Time frame: Day 30 (optional), 90 and 180
Walking ability data
Time frame: Day 30 (optional), 90 and 180
Device-related adverse events
Time frame: Up to day 180

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
Background: PubMed 16059696Papasimos 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.
Background: PubMed 17144789Burge 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.
Background: PubMed 6497603Zain 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.
Background: PubMed 2738306Cummings 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.
BackgroundCaiaffa 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
Background: PubMed 11379732Haidukewych 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.
Background: PubMed 11380135Olsson 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.

Related trials for Femoral Fractures

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vincenzo Caiaffa, MD principal investigator

S.C. Ortopedia e Traumatologia - P.O. Centrale "SS. Annunziata" ASL Taranto - Italy

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Femoral Fractures, run by Citieffe S.r.l at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EBA2 performance at day 90 (time frame: Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01599221, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.