Biomechanical and Histological Assessment of a Polyethylene Terephthalate Screw Retention Technology in an Ovine Metatarsal Fracture ModelFunding This work was funded by a research grant to Colorado State University (Fort Collins, Colorado, United States) from Woven Orthopedic Technologies (Manchester, Connecticut, United States).
03 May 2019
09 November 2019
23 February 2020 (online)
Objective Screw loosening in fracture fixation poses a clinical risk which may lead to implant failure, particularly in poor bone quality. The objective of this study was to examine the effectiveness of a novel screw retention technology (SRT) for increased screw purchase in a large animal metatarsal fracture model.
Study Design This was a biomechanical, radiographic, and histological study utilizing an ovine metatarsal fracture model. Twenty-four sheep metatarsi underwent 3-mm ostectomies and were repaired with a nine-hole plate and 3.5-mm screws placed in oversized 3.5-mm holes to simulate worst case revision surgeries (i.e. no initial screw thread bone contact). Sheep were sacrificed at 3, 6 or 12 weeks (n = 6 each) post-operation. Post-sacrifice, each surgically implanted screw underwent either destructive mechanical testing or histomorphometric analyses.
Results Treated metatarsi showed improved screw retention and normal fracture healing. Significant improvement in breakout strength and pullout strength of screws treated with the SRT were found as a function of healing time. Histologically, bone ingrowth at the screw interface was also shown to significantly increase with healing time. Improvements in fracture healing, indicated by an increase in bone fraction and decrease in void space at the osteotomy, were also observed with healing time.
Conclusion The results demonstrate the effectiveness of the SRT as a method for improved screw retention in a rescue-screw type scenario.
All authors drafted, revised and approved the submitted manuscript. Jeremiah Easley, Christian Puttlitz, Cecily Broomfield, Ross Palmer and Kirk C. McGilvray contributed to conception of study, study design, acquisition of data and data analysis and interpretation. Alexander Jones contributed to conception of study, study design, and data analysis and interpretation.
- 1 Collinge C, Hartigan B, Lautenschlager EP. Effects of surgical errors on small fragment screw fixation. J Orthop Trauma 2006; 20 (06) 410-413
- 2 Galbusera F, Volkheimer D, Reitmaier S, Berger-Roscher N, Kienle A, Wilke HJ. Pedicle screw loosening: a clinically relevant complication?. Eur Spine J 2015; 24 (05) 1005-1016
- 3 Fisher WD, Hamblen DL. Problems and pitfalls of compression fixation of long bone fractures: a review of results and complications. Injury 1978; 10 (02) 99-107
- 4 El Saman A, Meier S, Sander A, Kelm A, Marzi I, Laurer H. Reduced loosening rate and loss of correction following posterior stabilization with or without PMMA augmentation of pedicle screws in vertebral fractures in the elderly. Eur J Trauma Emerg Surg 2013; 39 (05) 455-460
- 5 Halvorson TL, Kelley LA, Thomas KA, Whitecloud III TS, Cook SD. Effects of bone mineral density on pedicle screw fixation. Spine 1994; 19 (21) 2415-2420
- 6 Hak DJ, McElvany M. Removal of broken hardware. J Am Acad Orthop Surg 2008; 16 (02) 113-120
- 7 Nieto H, Baroan C. Limits of internal fixation in long-bone fracture. Orthop Traumatol Surg Res 2017; 103 (1S): S61-S66
- 8 Wu ZX, Gong FT, Liu L. , et al. A comparative study on screw loosening in osteoporotic lumbar spine fusion between expandable and conventional pedicle screws. Arch Orthop Trauma Surg 2012; 132 (04) 471-476
- 9 Paré PE, Chappuis JL, Rampersaud R. , et al. Biomechanical evaluation of a novel fenestrated pedicle screw augmented with bone cement in osteoporotic spines. Spine 2011; 36 (18) E1210-E1214
- 10 Takigawa T, Tanaka M, Konishi H. , et al. Comparative biomechanical analysis of an improved novel pedicle screw with sheath and bone cement. J Spinal Disord Tech 2007; 20 (06) 462-467
- 11 Wall SJ, Soin SP, Knight TA, Mears SC, Belkoff SM. Mechanical evaluation of a 4-mm cancellous “rescue” screw in osteoporotic cortical bone: a cadaveric study. J Orthop Trauma 2010; 24 (06) 379-382
- 12 Yerby SA, Toh E, McLain RF. Revision of failed pedicle screws using hydroxyapatite cement. A biomechanical analysis. Spine 1998; 23 (15) 1657-1661
- 13 Pechon PH, Mears SC, Langdale ER, Belkoff SM. Salvaging the pullout strength of stripped screws in osteoporotic bone. Geriatr Orthop Surg Rehabil 2013; 4 (02) 50-52
- 14 Bronsnick D, Harold RE, Youderian A, Solitro G, Amirouche F, Goldberg B. Can high-friction intraannular material increase screw pullout strength in osteoporotic bone?. Clin Orthop Relat Res 2015; 473 (03) 1150-1154
- 15 Greiwe RM, Archdeacon MT. Locking plate technology: current concepts. J Knee Surg 2007; 20 (01) 50-55
- 16 Easley J, Puttlitz CM, Seim III H. , et al. Biomechanical and histologic assessment of a novel screw retention technology in an ovine lumbar fusion model. Spine J 2018; 18 (12) 2302-2315
- 17 Lejay A, Colvard B, Magnus L. , et al. Explanted vascular and endovascular graft analysis: where do we stand and what should we do?. Eur J Vasc Endovasc Surg 2018; 55 (04) 567-576
- 18 Fanous N, Tournas A, Côté V. , et al. Soft and firm alloplastic implants in rhinoplasty: why, when and how to use them: a review of 311 cases. Aesthetic Plast Surg 2017; 41 (02) 397-412
- 19 Patel K, Brandstetter K. Solid implants in facial plastic surgery: potential complications and how to prevent them. Facial Plast Surg 2016; 32 (05) 520-531
- 20 Dai Z, Bao W, Li S, Li H, Jiang J, Chen S. Enhancement of Polyethylene Terephthalate Artificial Ligament Graft Osseointegration using a Periosteum Patch in a Goat Model. Int J Sports Med 2016; 37 (06) 493-499
- 21 Li S, Ma K, Li H, Jiang J, Chen S. The effect of sodium hyaluronate on ligamentation and biomechanical property of tendon in repair of Achilles tendon defect with polyethylene terephthalate artificial ligament: a rabbit tendon repair model. BioMed Res Int 2016; 2016: 8684231
- 22 Ono W, Maruyama K, Ogiso M, Mineno S, Izumi Y. Implant insertion into an augmented bone region using the canine mandible augmented by the “casing method”. Anat Rec (Hoboken) 2018; 301 (05) 892-901
- 23 McGilvray KC, Easley J, Seim HB. , et al. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J 2018; 18 (07) 1250-1260
- 24 McGilvray KC, Waldorff EI, Easley J. , et al. Evaluation of a polyetheretherketone (PEEK) titanium composite interbody spacer in an ovine lumbar interbody fusion model: biomechanical, microcomputed tomographic, and histologic analyses. Spine J 2017; 17 (12) 1907-1916
- 25 Gadomski BC, McGilvray KC, Easley JT. , et al. An in vivo ovine model of bone tissue alterations in simulated microgravity conditions. J Biomech Eng 2014; 136 (02) 021020
- 26 Gadomski BC, McGilvray KC, Easley JT. , et al. An investigation of shock wave therapy and low-intensity pulsed ultrasound on fracture healing under reduced loading conditions in an ovine model. J Orthop Res 2018; 36 (03) 921-929
- 27 Gadomski BC, McGilvray KC, Easley JT, Palmer RH, Santoni BG, Puttlitz CM. Partial gravity unloading inhibits bone healing responses in a large animal model. J Biomech 2014; 47 (12) 2836-2842
- 28 McGilvray KC, Unal E, Troyer KL. , et al. Implantable microelectromechanical sensors for diagnostic monitoring and post-surgical prediction of bone fracture healing. J Orthop Res 2015; 33 (10) 1439-1446
- 29 Matityahu A, Hurschler C, Badenhop M. , et al. Reduction of pullout strength caused by reinsertion of 3.5-mm cortical screws. J Orthop Trauma 2013; 27 (03) 170-176
- 30 Oldakowski M, Oldakowska I, Kirk TB. , et al. Pull-out strength comparison of a novel expanding fastener against an orthopaedic screw in an ovine vertebral body: an ex-vivo study. J Med Eng Technol 2016; 40 (02) 43-51
- 31 Claes L, Eckert-Hübner K, Augat P. The fracture gap size influences the local vascularization and tissue differentiation in callus healing. Langenbecks Arch Surg 2003; 388 (05) 316-322
- 32 Augat P, Margevicius K, Simon J, Wolf S, Suger G, Claes L. Local tissue properties in bone healing: influence of size and stability of the osteotomy gap. J Orthop Res 1998; 16 (04) 475-481
- 33 Derinçek A, Türker M, Cinar M, Cetik O, Kalaycioğlu B. Revision of the failed pedicle screw in osteoporotic lumbar spine: biomechanical comparison of kyphoplasty versus transpedicular polymethylmethacrylate augmentation. Eklem Hastalik Cerrahisi 2012; 23 (02) 106-110
- 34 Wilke HJ, Kettler A, Claes LE. Are sheep spines a valid biomechanical model for human spines?. Spine 1997; 22 (20) 2365-2374
- 35 Wilke HJ, Kettler A, Wenger KH, Claes LE. Anatomy of the sheep spine and its comparison to the human spine. Anat Rec 1997; 247 (04) 542-555