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The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 2 | Pages 265 - 272
1 Feb 2007
Ristiniemi J Flinkkilä T Hyvönen P Lakovaara M Pakarinen H Jalovaara P

External fixation of distal tibial fractures is often associated with delayed union. We have investigated whether union can be enhanced by using recombinant bone morphogenetic protein-7 (rhBMP-7). Osteoinduction with rhBMP-7 and bovine collagen was used in 20 patients with distal tibial fractures which had been treated by external fixation (BMP group). Healing of the fracture was compared with that of 20 matched patients in whom treatment was similar except that rhBMP-7 was not used. Significantly more fractures had healed by 16 (p = 0.039) and 20 weeks (p = 0.022) in the BMP group compared with the matched group. The mean time to union (p = 0.002), the duration of absence from work (p = 0.018) and the time for which external fixation was required (p = 0.037) were significantly shorter in the BMP group than in the matched group. Secondary intervention due to delayed healing was required in two patients in the BMP group and seven in the matched group. RhBMP-7 can enhance the union of distal tibial fractures treated by external fixation


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 89 - 89
1 Nov 2021
Zderic I Caspar J Blauth M Weber A Koch R Stoffel K Finkemeier C Hessmann M Gueorguiev B
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Introduction and Objective. Intramedullary nails are frequently used for treatment of unstable distal tibia fractures. However, insufficient fixation of the distal fragment could result in delayed healing, malunion or nonunion. The quality of fixation may be adversely affected by the design of both the nail and locking screws, as well as by the fracture pattern and bone density. Recently, a novel concept for angular stable nailing has been developed that maintains the principle of relative stability and introduces improvements expected to reduce nail toggling, screw migration and secondary loss of reduction. It incorporates polyether ether ketone (PEEK) inlays integrated in the distal and proximal canal portions of the nail for angular stable screw locking. The nail can be used with new standard locking screws and low-profile retaining locking screws, both designed to enhance cortical fixation. The low-profile screws are with threaded head, anchoring in the bone and increasing the surface contact area due to the head's increased diameter. The objective of this study was to investigate the biomechanical competence of the novel angular stable intramedullary nail concept for treatment of unstable distal tibia fractures, compared with four other nail designs in an artificial bone model under dynamic loading. Materials and Methods. The distal 70 mm of thirty artificial tibiae (Synbone) were assigned to 5 groups for distal locking using either four different commercially available nails – group 1: Expert Tibia Nail (DePuy Synthes); group 2: TRIGEN META-NAIL with Internal Hex Captured Screws (Smith & Nephew); group 3: T2 Alpha with Locking Screws (Stryker); group 4: Natural Nail System featuring StabiliZe Technology (Zimmer) – or the novel angular stable TN-Advanced nail with low-profile screws (group 5, DePuy Synthes). The distal locking in all groups was performed using 2 mediolateral screws. All specimens were biomechanically tested under quasi-static and progressively increasing combined cyclic axial and torsional loading in internal rotation until failure, with monitoring by means of motion tracking. Results. Initial nail toggling of the distal tibia fragment in group 5 was significantly lower as compared with group 3 in varus (p=0.04) or with groups 2 and 4 in flexion (p≤0.02). In addition, the toggling in varus was significantly lower in group 1 versus group 4 (p<0.01). Moreover, during dynamic loading, within the course of the first 10,000 cycles the movements of the distal fragment in terms of varus, flexion, internal rotation, as well as axial and shear displacements at the fracture site, were all significantly lower in group 5 compared with group 4 (p<0.01). Additionally, group 5 demonstrated significantly lower values for flexion versus groups 2 and 3 (p≤0.04), for internal rotation versus group 1 (p=0.03), and for axial displacement versus group 3 (p=0.03). A trend to significantly lower values was detected in group 5 versus group 1 for varus, flexion and shear displacement – with p ranging between 0.05 and 0.07 – and versus group 3 for shear displacement (p=0.07). Cycles to failure were highest in group 5 with a significant difference to group 4 (p<0.01). Conclusions. From a biomechanical perspective, the novel angular stable intramedullary nail concept with integrated PEEK inlays and low-profile screws provides ameliorated resistance against nail toggling and loss of reduction under static and dynamic loading compared with other commercially available intramedullary nails used for fixation of unstable distal tibia fractures


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 27 - 27
1 Dec 2020
Gueorguiev B Zderic I Blauth M Weber A Koch R Dauwe J Schader J Stoffel K Finkemeier C Hessmann M
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Unstable distal tibia fractures are challenging injuries requiring surgical treatment. Intramedullary nails are frequently used; however, distal fragment fixation problems may arise, leading to delayed healing, malunion or nonunion. Recently, a novel angle-stable locking nail design has been developed that maintains the principle of relative construct stability, but introduces improvements expected to reduce nail toggling, screw migration and secondary loss of reduction, without the requirement for additional intraoperative procedures. The aim of this study was to investigate the biomechanical competence of a novel angle-stable intramedullary nail concept for treatment of unstable distal tibia fractures, compared to a conventional nail in a human cadaveric model under dynamic loading. Ten pairs of fresh-frozen human cadaveric tibiae with a simulated AO/OTA 42-A3.1 fracture were assigned to 2 groups for reamed intramedullary nailing using either a conventional (non-angle-stable) Expert Tibia Nail with 3 distal screws (Group 1) or the novel Tibia Nail Advanced system with 2 distal angle-stable locking low-profile screws (Group 2). The specimens were biomechanically tested under conditions including quasi-static and progressively increasing combined cyclic axial and torsional loading in internal rotation until failure of the bone-implant construct, with monitoring by means of motion tracking. Initial axial construct stiffness, although being higher in Group 2, did not significantly differ between the 2 nail systems, p=0.29. In contrast, initial torsional construct stiffness was significantly higher in Group 2 compared to Group 1, p=0.04. Initial nail toggling of the distal tibia fragment in varus and flexion was lower in Group 2 compared to Group 1, being significant in flexion, p=0.91 and p=0.03, respectively. After 5000 cycles, interfragmentary movements in terms of varus, flexion, internal rotation, axial displacement and shear displacement at the fracture site were all lower in Group 2 compared to Group 1, with flexion and shear displacement being significant, p=0.14, p=0.04, p=0.25, p=0.11 and p=0.04, respectively. Cycles to failure until both interfragmentary 5° varus and 5° flexion were significantly higher in Group 2 compared to Group 1, p=0.04. From a biomechanical perspective, the novel angle-stable intramedullary nail concept has the potential of achieving a higher initial axial and torsional relative stability and maintaining it with a better resistance towards loss of reduction under dynamic loading, while reducing the number of distal locking screws, compared to conventional locking in intramedullary nailed unstable distal tibia fractures


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 110 - 110
1 Nov 2021
Ahmed M Barrie A Kozhikunnath A Thimmegowda A Ho S Kunasingam K Guryel E Collaborative M
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Introduction and Objective. Lower limb fractures are amongst the most common surgically managed orthopaedic injuries, with open reduction and internal fixation (ORIF) as the conventional method of treatment of the fibula. In recent years, dedicated intramedullary implants have emerged for fibula fixation in tandem with the move towards minimally invasive surgery in high-risk patients. This is the largest multicentre review to date with the aim of establishing the clinical outcomes following intramedullary nail (IMN) fixation of the fibula and to identify the absolute indication for fibula IMN fixation. Materials and Methods. A retrospective study of adult patients in all UK hospitals, who underwent fibula nail fixation between 01/01/2018 and 31/10/2020 was performed. Primary outcome measures included time to union, infection rate, other post-operative complications associated with the fixation and length of hospital stay. The secondary outcome measure was to identify the indication for fibula nailing. Data tabulation was performed using Microsoft Excel and analysis was performed using SPSS Version 23 (SPSS Statistics). Results. 2 Major Trauma Centres (MTCs) and 9 Trauma Units (TUs) were eligible for inclusion. 102 patients were included and 91% were classified as ankle fractures of 68% (n=69) were Weber B, 24% (n=24) Weber C and 8% (n=9) were either distal tibial fractures with an associated fibula fracture or pilon fractures. The mean age was 64 years of which 45 were male patients and 57 were female. The average BMI was 30.03kg/m. 2. and 44% of patients were ASA 3. 74% of patients had poor pre-op skin condition including swelling and open wounds. The calculated infection rate for fibula nail was 4.9% and metal-work complication rate was 4.9%. The average time to union was 13 weeks and length of inpatient stay was 15 days (SD +/− 12 days). Conclusions. MEFNO has demonstrated that fibula nail is an ideal implant in patients who have a physiologically higher risk of surgery, poor skin condition and a complex fracture pattern. The time to union, complication and infection risks are lower than that reported in literature for ankle ORIFs


Bone & Joint Research
Vol. 5, Issue 10 | Pages 500 - 511
1 Oct 2016
Raina DB Gupta A Petersen MM Hettwer W McNally M Tägil M Zheng M Kumar A Lidgren L

Objectives

We have observed clinical cases where bone is formed in the overlaying muscle covering surgically created bone defects treated with a hydroxyapatite/calcium sulphate biomaterial. Our objective was to investigate the osteoinductive potential of the biomaterial and to determine if growth factors secreted from local bone cells induce osteoblastic differentiation of muscle cells.

Materials and Methods

We seeded mouse skeletal muscle cells C2C12 on the hydroxyapatite/calcium sulphate biomaterial and the phenotype of the cells was analysed. To mimic surgical conditions with leakage of extra cellular matrix (ECM) proteins and growth factors, we cultured rat bone cells ROS 17/2.8 in a bioreactor and harvested the secreted proteins. The secretome was added to rat muscle cells L6. The phenotype of the muscle cells after treatment with the media was assessed using immunostaining and light microscopy.