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

NCT01599221 | Unknown

• 1 other identifier: EBA2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Femoral Fractures

Keywords

Femoral fractures; Nail; Implant; Elderly; Orthopaedics

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• SF12 Questionnaire

  Day 30 (optional), 90 and 180

• Clinical evaluation of pain

  Day 30 (optional), 90 and 180

• Radiographic examination

  Day 30 (optional), 90 and 180

• Walking ability data

  Day 30 (optional), 90 and 180

• Device-related adverse events

  Up to day 180

Study Arms (1)

Subjects with EBA2

Subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures

Device: EBA2

Interventions

EBA2 DEVICE

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

Also known as: Endovis B.A.

Subjects with EBA2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Citieffe S.r.l: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (3)

Azienda Ospedaliero-Universitaria Consorziale Policlinico

Bari, 70124, Italy

Location

Unità operativa complessa di Ortopedia e Traumatologia - AUSL 12 di Viareggio

Lido di Camaiore, Italy

Location

S.C. Ortopedia e Traumatologia - P.O. Centrale SS. Annunziata

Taranto, 74100, Italy

Location

Related Publications (7)

• 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.

  PMID: 16059696 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.

  PMID: 17144789 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.

  PMID: 6497603 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.

  PMID: 2738306 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

  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.

  PMID: 11379732 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.

  PMID: 11380135 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Vincenzo Caiaffa, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 15, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 11, 2012

Record last verified: 2012-05

Locations

IT (3)