TRIGEN^◊ INTERTAN^◊

Your patients can enjoy life after hip fracture

The evidence is in!  Based on data from more than two-dozen published studies, the TRIGEN INTERTAN Intertrochanteric Antegrade Nail allows femur (hip) fracture patients to experience:

• Lower risk of implant failure and non-union^{6,7,8,9,10,11,12,13,14,15}
• Reduced postoperative pain^{9,10,11,13,14,15}
• Faster time to fracture union^{9,11,12,13,19,23,24,25,26,27,28,29}
• Proven high return to pre-fracture status^6,13,19,23

Features and Benefits

• Maintain compression and eliminate Z-effect
• Intertrochanteric rotational stability
• Control rotation during reduction
• Eliminate medial migration
• Prevent periprosthetic fractures

Challenge:  Post-Operative Complications

Solution:  Lower risk of implant failure and non-union^{6,7,8,9,10,11,12,13,14,15}

Challenge:  Pain management

Solution:  Reduced postoperative pain^{9,10,11,13,14,15}

Challenge:  Delayed healing

Solution:  Faster time to fracture union^{9,11,12,13,19,23,24,25,26,27,28,29}

Challenge:  Poor functional outcomes

Solution:  Proven high return to pre-fracture status^6,13,19,23

References:

1.American Academy of Orthopaedic Surgeons. Hip fractures in seniors: a call for health system reform. Position Statement 1144. Rosemont, IL: 1999. 

2. Mundi S et al. Similar mortality rates in hip fracture patients over the past 31 years: A systematic review of RCTs. Acta Orthopaedica 2014; 85(1): 54-59. 

3. Bentler SE, Liu L, Obrizan M, Cook EA, Wright KB, Geweke JF, et al. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am. J Epidemiol. 2009 Nov 15;170(10):1290-9. doi: 10.1093/aje/kwp266. 

4. Brujin K, Hartog D, Tuinebreijer W, Roukema G. Reliability of Predictors for Screw Cutout in Intertrochanteric Hip Fractures. J Bone Joint Surg Am. 2012;94:1266-1272. 

5. Hoffmann S, Paetzold R, Stephan D, Püschel K, Buehren V, Augat P. Biomechanical evaluation of interlocking lag screw design in intramedullary nailing of unstable pertrochanteric fractures. J Orthop Trauma. 2013;27(9):483-490. 

6. Berger-Groch J, Rupprecht M, Schoepper S, Schroeder M, Rueger JM, Hoffmann M. Five-Year Outcome Analysis of Intertrochanteric Femur Fractures: A Prospective Randomized Trial Comparing a 2-Screw and a Single-Screw Cephalomedullary Nail. J Orthop Trauma. 2016;30:483-488. 

7. Matre K, Vinje T, Havelin LI, et al. TRIGEN INTERTAN intramedullary nail versus sliding hip screw:a prospective, randomized multicenter study on pain, function, and complications in 684 patients with an intertrochanteric or subtrochanteric fracture and one year of follow-up. J Bone Joint Surg Am. 2013;95:200-208. 

8. Sanders D, Bryant D, Tieszer C, et al. A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures. J Orthop Trauma. 2017;31:1-8. 

9. Seyhan M, Turkmen I, Unay K, Ozkut AT. Do PFNA devices and Intertan nails both have the same effects in the treatment of trochanteric fractures? A prospective clinical study. J Orthop Sci. 2015;20:1053-1061. 

10. Su H, Sun K, Wang X. A randomized prospective comparison of Intertan and Gamma3 for treating unstable intertrochanteric fractures. Int J Clin Exp Med. 2016;9:8640-8647. 

11. Zhang S, Zhang K, Jia Y, Yu B, Feng W. InterTan nail versus Proximal Femoral Nail Antirotation-Asia in the treatment of unstable trochanteric fractures. Orthopedics. 2013;36:e288-294 

12. Wang Q, Yang X, He HZ, Dong LJ, Huang DG. Comparative study of InterTAN and Dynamic Hip Screw in treatment of femoral intertrochanteric injury and wound. Int J Clin Exp Med. 2014;7:5578-5582. 

13. Wu Y, Watson JT, Kuldjanov D, Jackman J. Rotationally stable fixation for intertrochanteric hip fractures: the Intertan experience, surgical technique, and outcomes. Techniques in Ortho. 2014;29;3:120-132 

14. Yu W, Zhang X, Zhu X, Hu J, Liu Y. A retrospective analysis of the InterTan nail and proximal femoral nail anti-rotation-Asia in the treatment of unstable intertrochanteric femur fractures in the elderly. J Orthop Surg Res. 2016;11:10. 

15. Zehir S, Sahin E, Zehir R. Comparison of clinical outcomes with three different intramedullary nailing devices in the treatment of unstable trochanteric fractures. Ulus Travma Acil Cerrahi Derg, 2015;21(6:469-476. 

16. Leo N, Dunbar C, Ridgway J, Horner A. The TRIGEN INTERTAN Intertrochanteric Antegrade Nail: A Systematic Literature Review and Meta-analysis of Clinical Outcomes Compared to Standard of Care in the Treatment of Intertrochanteric Hip Fractures. Bone&Joint Outcome. 2017:4(1):1-20. Lit no: 10205 V1 07/17.

17. Serrano-Riera R, Blair JA, Downes K, Sanders R. Cephalo-medullary nail fixation of intertrochanteric fractures: are two proximal screws better than one? Abstract presented at: Orthopaedic Trauma Association Annual Meeting; October 15-18, 2014; Tampa, FL, USA. 

18. Santoni B, Nayak A, Cooper S, et al. Comparison of Femoral Head Rotation and Varus Collapse Between a Single Lag Screw and Integrated Dual Screw Intertrochanteric Hip Fracture Fixation Device Using a Cadaveric Hemi-Pelvis Biomechanical Model. J Orthop Trauma. 2016;30:164-169. 

19. Ruecker AH, Rupprecht M, Gruber M, Gebauer M, Barve s using an intramedullary nail with integrated cephalocervical screws and linear compression. J Orthop Trauma 2009;23:22–30 

20. Galli M, Ciriello V, Bocchino L, Gangemi NM, Peruzzi M, Marzetti E. Clinical and functional outcomes of internal fixation with intertrochanteric antegrade nail in older patients with proximal extracapsular femoral fractures. Eur J Trauma Emerg Surg. 2013/10/17 2013:1-6. 

21. Zanzone A. Current Challenges in Pain Management in Hip Fracture Patients. J Orthop Trauma. 2016;30:S1-S5. 

22. Abou-Setta A, Beaupre L, Jones C, et al. Pain Management Interventions for Hip Fracture. Agency for Healthcare Research and Quality. 2011;Publication No. 11-EHC022-EF. 

23. Kim JW, Kim TY, Ha YC, Lee YK, Koo KH. Outcome of intertrochanteric fractures treated by intramedullary nail with two integrated lag screws: A study in Asian population. Indian J Orthop. 2015;49:436-441. 

24. Tao R, Lu Y, Xu H, Zhou ZY, Wang YH, Liu F. Internal fixation of intertrochanteric hip fractures: a clinical comparison of two implant designs. Sci World J. 2013;2013:1-8. 

25. Huang FT, Lin KC, Yang SW, Renn JH. Comparative study of the proximal femoral nail antirotation versus the reconstruction nail in the treatment of comminuted proximal femoral fracture. Orthopedics. 2012;35:e41-47. 

26. Sahin EK, Imerci A, Kinik H, Karapinar L, Canbek U, Savran A. Comparison of proximal femoral nail antirotation (PFNA) with AO dynamic condylar screws (DCS) for the treatment for unstable peritrochanteric femoral fractures. Eur J Orthop Surg Traumatol. 2014;24:347-352. 

27. Hsueh K, Fang C. Risk factors in cutout of sliding hip screw in intertrochanteric fractures: an evaluation of 937 patients. Int Orthop. 2010;34:1273-1276. 

28. Liu Y, Tao R, Liu F, et al. Mid-term outcomes after intramedullary fixation of peritrochanteric femoral fractures using the new proximal femoral nail antirotation (PFNA). Injury. 2010;41:810-817. 

29. Riha D, Bartoni´cek J. Internal fixation of pertrochanteric fractures using DHS with a two-hole side-plate. Int Orthop. 2010;34:877-882. 

30. Gaston MS, Simpson AHRW. Inhibition of fracture healing.J Bone Joing Surg Br. 2007:89-B:1553-1560. 

31. Rueger J, Moore C. Shortening of the femoral neck following peritrochanteric fracture. Bone Joint Sci. 2011 May;2(5). 

32. Zlowodzki M, Brink O, Switzer J, et al. The effect of shortening and varus collapse of the femoral neck on function after fixation of intracapsular fracture of the hip. J Bone Joint Surg Br. 2008;90:1487-1494. 

33. Baldwin P, Lavender R, Sanders R, Koval K. Controversies in Intramedullary Fixation for Intertrochanteric Hip Fractures. J Orthop Trauma. 2016;30:635-641. 

34. Ollivere B, Das A, Shivji F. Hip fractures: The state of the art in 2017. The British Editorial Society of Bone & Joint Surgery. 2017;6:3.

05036 V2 0817

Disclaimer: The results of in vitro simulation testing have not been proven to predict clinical performance.

This information is intended for health care professionals only.  

TRIGEN^◊ INTERTAN^◊ Papers

Evidence in Focus 

Significantly shorter length of stay and higher return to pre-fracture status with TRIGEN INTERTAN compared with a single lag screw cephalomedullary nail

INTERTAN results in significantly less limb shortening in treated geriatric hip fractures as compared with a sliding hip screw (SHS)

TRIGEN INTERTAN has significantly less femoral neck shortening and varus collapse compared with a single lag screw cephalomedullary nail

INTERTAN provides significantly greater fracture compression and reduced
femoral shortening than a helical blade cephalomedullary nail

TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nail achieves improved clinical and patient outcomes at a lower cost compared to single screw nails for fixation of unstable intertrochanteric (IT) fractures

TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nail achieves more reliable fixation of unstable intertrochanteric (IT) hip fractures than single screw nails

TRIGEN INTERTAN Claims Brochure The benefits of the TRIGEN INTERTAN system – lower risk of implant failure and non-union, reduced postoperative pain, faster time to fracture union, and a proven high return to pre-fracture status – can help you achieve better outcomes more efficiently.

Bone and Joint Outcome Whitepaper A systematic literature review and meta-analysis of the literature found that, compared to those treated with comparator devices theTRIGEN INTERTAN nail results in: • A 69% reduction in implant failures (p=0.001) • A 73% reduction in non-unions (p=0.01) • A 54% reduction in patients complaining of hip andthigh pain (p=0.003) • Improvement in health related quality of life,as measured by the SF-36 (physical health) score,in a single study (p=0.002)

	Shortening of the Femoral Neck Following Peritrochanteric Fracture Rueger J, Moore C. Shortening of the femoral neck following peritrochanteric fracture. Bone&Joint Science ( http://www.smith-nephew.com/education/ )2011; 2(5). “… the newly developed INTERTAN intertrochanteric antegrade nail improves rotational fracture stability and allows for intraoperative interfragmentary compression, thereby reducing the erosion of the fracture surfaces between the lateral end of the neck fragment and the trochanteric region that might result in uncontrolled collapse with the risk of shortening.”
	The Treatment of Intertrochanteric Fractures: Results Using an Intramedullary Nail With Integrated Cephalocervical Screws and Linear Compression Ruecker, Andreas H; Rupprecht, M; Gruber, M; Gebauer, M; Barvencik, F; Briem, D; Rueger, J M Journal of Orthopaedic Trauma, January 2009,23(1):22-30 “Objective: A new device for the treatment of intertrochanteric fractures that uses 2 cephalocervical screws in an integrated mechanism allowing linear intraoperative compression and rotational stability of the head/neck fragment has been developed. The aim of this study was to describe the results using this device for the treatment of stable and unstable intertrochanteric fractures.”
	TRIGEN INTERTAN Cycle Testing The TRIGEN INTERTAN nail was compared to single lag screw and helical blade devices in a Sommers cut out test protocol of 100,000 cycles. The TRIGEN INTERTAN device was superior to the other devices and had no incidence of cut out.
	Evaluation of Cyclic Cut-Out Failure in Intramedullary Nails: A Comparison of Single Lag Screws and Integrated Interlocking Screws Written by: TA Russell, SA Summy and SA Whitten all of Campbell Clinic “The purpose of this research is to compare cutout of this new screw configuration to that of a single lag screw or helical blade under dynamic loading.”
	TRIGEN INTERTAN vs Stryker Gamma3TM summary Hoffmann S, Paetzold R, Stephan D, Püschel K, Buehren V, Augat P. Biomechanical evaluation of interlocking lag screw design in intramedullary nailing of unstable pertrochanteric fractures. J Orthop Trauma. 2013 Sep;27(9):483-90.

Case Studies

	Textbook Case Study- 83 YOF with a Peritrochanteric Hip Fracture Fixation and intraoperative compression of a peritrochanteric hip fracture 83-year-old female, three-part peritrochanteric hip fracture
	Case Study- 48 YOM with a Peritrochanteric Hip Fracture Cephalomedullary nailing and intraoperative compression of a peritrochanteric hip fracture 48-year-old male, injured in a fall causing a two-part peritrochanteric hip fracture

Design and Technology of the TRIGEN INTERTAN Intertrochanteric Antegrade Nail for use in femur (hip) fractures.  

View the Video of theTRIGEN^◊ INTERTAN^◊ Compression

• Active linear compression - compression of the femur fracture with rotational control
• Eliminates excessive sliding reducing the incidence of femoral neck shortening
• Medial migration and Z-effect nearly impossible ¹

Steps of active linear compression

• Smaller 7mm compression screw head engages the nail
• The 11mm lag screw and femoral neck/head begin to move laterally
• Nail and shaft of the femur begin to move medially
• Linear compression is achieved in a controlled fashion

Active linear compression helps unload the lateral wall and restore the proximal femur. Note: The INTERTAN compression screw is always against the nail. This makes medial migration and the Z-effect nearly impossible. ¹

View the Video of theTRIGEN INTERTAN Compression in Fluoro

Trapezoidal nail shape Small proximal diameter of the nail (15.25mm x 16.25mm) More material on the lateral side of the nail preserves the lateral wall Helps combat forces that cause instability and varus collapse Provides a press-fit in the metaphyseal region of the proximal femur

References

1. Rueger Johannes; Moore Chris. Shortening of the Femoral Neck Following Peritrochanteric Fracture. Bone & Joint Science. Vol. 2, No. 5, May 2011.

Indications for TRIGEN^◊ INTERTAN^◊

Fractures of the femur including:

• Simple shaft fractures
• Comminuted shaft fractures
• Spiral shaft fractures
• Long oblique shaft fractures
• Segmental shaft fractures
• Subtrochanteric fractures
• Intertrochanteric fractures
• Ipsilateral femoral shaft/neck fractures
• Intracapsular fractures
• Nonunions and malunions
• Polytrauma and multiple fractures
• Prophylactic nailing of impending pathologic fractures
• Reconstruction following tumor resection and grafting
• Bone lengthening and shortening

INTERTAN^◊ FAQs

Why does the INTERTAN nail have a trapezoidal shape?

The smaller cross-section of the INTERTAN nail has the advantage of preserving the Gluteus Medius Tendon while at the same time not compromising the overall strength of the implant. The trapezoidal shape of the nail places more material at the lateral side of the implant where tensile forces are typically the strongest. In addition, the nail's trapezoidal profile also provides enhanced anatomical fit and added rotational stability in the proximal femoral metaphysis similar to that offered by conventional hip stems.

What is an Integrated Interlocking Screw configuration and how will it help my patients?

The integrated interlocking screws of the INTERTAN system increase stability and resistance to both intra and post-operative fracture rotation about the implant by providing two points of fixation within the femoral neck and head. This directly reduces rotational instability and eliminates the possibility of implant failure due to Z-Effect.⁶ The integrated screw configuration is a fourth generation intramedullary nail concept combining the enhanced rotational stability of the TRIGEN Reconstruction Nail with the superior controlled sliding and compression of the IMHS™ implant. The INTERTAN system incorporates aspects of both devices by providing both single and dual integrated lag screws for the treatment of most major fracture patterns.

What is Z-Effect and how does INTERTAN solve it?

Z-Effect⁶ is an unfortunate by-product of most intramedullary nails that utilize two screws placed up into the femoral neck and head. Typically, the superior screw is of smaller diameter than the inferior and bears a disproportionate amount of load during weight bearing. Excessive varus forces placed on the smaller screw at the lateral cortex cause it to toggle and either back out or migrate through the femoral head into the acetabulum. The larger inferior screw is neither keyed in rotation nor locked in place, and it too will either back out or migrate medially. The resultant Z-Effect where the two screws move in opposite directions is one mode of failure for the conventional two screw reconstruction device. The INTERTAN nail turns that construct upside down and integrates the two screws so that they act as one device to bear all load, enact all compression and prevent excessive medial or lateral migration thus negating the Z-Effect.

Why does the short nail have a clothespin distal tip?

The clothespin distal tip of the INTERTAN short nail reduces the overall cross-sectional stiffness of the implant to minimize the risk of iatrogenic fracture during insertion, to ease the actual process of nail insertion and to offer enhanced rotational stability within the proximal femoral canal. As the distal tip of the INTERTAN nail encounters the AP bow of the proximal femur, it closes slightly changing the implant's straight profile to bent. This has the advantage of lessening point stresses about the distal tip of the nail and reducing the possibility of fracture due to a stress riser at that location.

I have been using a single screw IM device for the last 20 years and have yet to have one cut out. Do I have to use the integrated screws?

Absolutely not. One of the advantages of the INTERTAN system is that it provides you with options to treat a wide variety of fracture patterns. However, you are probably well aware that approximately 25% of all hip fractures are unstable and one in five (20%) will actually fail due to implant cut out.

Our designing surgeons feel that rotational instability is a major contributing factor to that failure rate and propose the INTERTAN nail as the solution to this dilemma. The problem lies in the fact that even implants that are keyed to prevent rotation can still experience rotation of the fragments about the axis of the lag screw. Placement of a secondary point of fixation into the femoral neck and head reduces the chances of rotation but adds the secondary concern of Z-Effect.

Watch video of head rotations with a conventional single lag screw device

The INTERTAN nail solves that problem by integrating two screws so that they function as one unit to prevent rotation and excessive screw migration. Mechanical testing of the two screw construct was stopped at 100,000 cycles with no evidence of implant cut out, further reinforcing the INTERTAN nail philosophy.

For additional questions, please contact your local sales representative.

 

References
1. www.aaos.org
2. http://www.springerlink.com/content/f9np64c0v3hch57w/
3. Koval KJ; Zuckerman JD. Functional recovery after fracture of the hip. J Bone Joint Surg (A). 1994: 76-1, 751-758.
4. AAOS Position Statement 1144. Hip fracture in seniors: A call for health system reform.
5. Rueger Johannes; Moore Chris. Shortening of the Femoral Neck Following Peritrochanteric Fracture. Bone & Joint Science. Vol. 2, No. 5, May 2011
6. Rueger J, Moore C. Shortening of the Femoral Neck Following Peritrochanteric Fracture. Bone&Joint Science ( www.KLEOS.md) 2011; 2(5)