Surgical treatment of fragility sacrum fractures with percutaneous sacroiliac (SI) screw fixation is associated with high failure rates in terms of screw loosening, cut-through and turn-out. The latter is a common cause for complications, being detected in up to 20% of the patients. The aim of this study was to develop a new screw-in-screw concept and prototype implant for fragility sacrum fracture fixation and
It is common belief that consolidated intramedullary nailed trochanteric femur fractures can result in secondary midshaft or supracondylar fractures, involving the distal screws, when short or long nails are used, respectively. In addition, limited data exists in the literature to indicate when short or long nails should be selected for treatment. The aim of this biomechanical cadaveric study was to investigate short versus long Trochanteric Femoral Nail Advanced (TFNA) fixation in terms of construct stability and generation of secondary fracture pattern following trochanteric fracture consolidation. Eight intact human cadaveric femur pairs were assigned to 2 groups of 8 specimens each for nailing using either short or long TFNA with blade as head element. Each specimen was first biomechanically preloaded at 1 Hz over 2000 cycles in superimposed synchronous axial compression to 1800 N and internal rotation to 11.5 Nm. Following, internal rotation to failure was applied over an arc of 90° within 1 second under 700 N axial load. Torsional stiffness, torque at failure, angle at failure and energy at failure were evaluated. Fracture patterns were analyzed. Outcomes in the groups with short and long nails were 9.7±2.4 Nm/° and 10.2±2.9 Nm/° for torsional stiffness, 119.8±37.2 Nm and 128.5±46.7 Nm for torque at failure, 13.5±3.5° and 13.4±2.6° for angle at failure, and 887.5±416.9 Nm° and 928.3±461.0 Nm° for energy at failure, respectively, with no significant differences between them, P≥0.167. Fractures through the distal locking screw occurred in 5 and 6 femora instrumented with short and long nails, respectively. Fractures through the lateral entry site of the head element were detected in 3 specimens within each group. For short nails, fractures through the distal shaft region, not interfacing with the implant, were detected in 3 specimens. From biomechanical perspective, the risk of secondary peri-implant fracture after intramedullary nailed trochanteric fracture consolidation is similar when using short or long TFNA. Moreover, for both nail versions the fracture pattern does not unexceptionally involve the distal locking screw.
In severe cases of total knee & hip arthroplasty, where off-the-shelf implants are not suitable (i.e., in cases with extended bone defects or periprosthetic fractures), 3D-printed custom-made knee & hip revision implants out of titanium or cobalt-chromium alloy represent one of the few remaining clinical treatment options. Design verification and validation of such custom-made implants is very challenging. Therefore, a methodology was developed to support surgeons and engineers in their decision on whether a developed design is suitable for the specific case. A novel method for the pre-clinical testing of 3D-printed custom-made knee implants has been established, which relies on the
In severe cases of total knee arthroplasty which cannot be treated with off-the-shelf implants anymore custom-made knee implants may serve as one of the few remaining options to restore joint function or to prevent limb amputation. Custom-made implants are specifically designed and manufactured for one individual patient in a single-unit production, in which the surgeon is responsible for the implant design characteristics in consultation with the corresponding engineer. The mechanical performance of these custom-made implants is challenging to evaluate due to the unique design characteristics and the limited time until which the implant is needed. Nevertheless, the custom-made implant must comply with clinical and regulatory requirements. The design of custom-made implants is often based on a underlying reference implant with available
Introduction. The Achilles tendon is the thickest and strongest tendon in the human body. Even though the tendon is so strong, it is one of the most frequently injured tendons. Treatment of patients after rupture is planned conservatively and surgically. Conservative treatment is generally applied to elderly patients with sedentary lives. If the treatment is surgical, it can be planned as open surgery or percutaneous surgery. In our study with rabbits, we wrapped a membrane made of plga (polylactic-co-glycolic acid) nanotubes impregnated with type 1 collagen around the tendon in rabbits that underwent open Achilles tendon repair surgery. After surgery, biomechanical and histological tests were performed on the tendons. Method. In the study consisting of 24 rabbits, 2 groups were created by random distribution. In the study group, after the Achilles tendon rupture was created, a type 1 collagen-impregnated plga-based membrane was placed around the tendon after the repair of 1 modified Kesslerr suture. In the control group, after the Achilles tendon rupture was created, 1 modified Kessler suture and Tendon repair was performed with the application of 3 primary sutures. At the end of the 6th week of the study, the rabbits in 2 groups were randomly distributed and histological examination was performed. Additionally,
A novel EP4 selective agonist (KMN-159) was developed [1] and has been proven that it can act as an osteopromotive factor to repair critical-size femoral bone defects in rats at a dose-dependent manner [2]. Based on its osteopromotive properties, we hypothesized that KMN-159 could also aid in bone formation for spinal fusion. Therefore, the aim of this study was to investigate its spinal fusion effect in a dorsolateral spinal fusion model in rats. This study was performed on 192, 10-week-old male Wistar rats. The rats were randomized into 8 groups (n = 12 per group): 1) SHAM (negative control), 2) MCM (scaffold only), 3) MCM + 20 µg BMP-2 (positive control), 4-8) MCM + 0.2, 2, 20, 200 or 2000 µg KMN-159. A posterolateral intertransverse process spinal fusion at L4 to L5 was performed bilaterally by implanting group dependent scaffolds (see above) or left empty in the SHAM group (protocol no. 25-5131/474/38). Animals were euthanized after 3 weeks and 6 weeks for µCT and
Abstract. Introduction. Persistent medial laxity increases the risk of failure for ACL reconstruction. To address this, multiple reconstruction techniques have been created. To date, no single strand reconstruction constructs have been able to restore both valgus and rotational stability. In response to this, a novel single strand Short Isometric Construct (SIC) MCL reconstruction was developed. Methods. Eight fresh-frozen cadaveric specimens were tested in three states: 1) intact 2) after sMCL and dMCL transection, and 3) after SIC MCL reconstruction. In each state, four loading conditions were applied at varying flexion angles: 90N anterior drawer, 5Nm tibial external rotation torque, 8Nm valgus torque, and combined 90N anterior drawer plus 5Nm tibial external rotation torque. Results. Transection of the sMCL and dMCL resulted in increased laxity with external rotation torque, valgus torque, and combined anterior drawer plus external rotation. SIC MCL reconstruction restored external rotation and valgus stability to intact levels throughout all degrees of flexion. In the combined test SIC MCL reconstruction also restored stability to intact levels for both anterior distraction and external rotation throughout the range of motion. No significant differences were noted between intact and SIC reconstruction. Conclusion. The single-limb short isometric construct (SIC) MCL reconstruction restored native valgus and rotatory stability to a sMCL- and dMCL-deficient knee in
Introduction. A long nail is often recommended for treatment of complex trochanteric fractures but requires longer surgical and fluoroscopy times. A possible solution could be a nail with an appropriate length which can be locked in a minimally invasive manner by the main aiming device. We aimed to determine if such a nail model* offers similar structural stability on
Little information exists when using cell viability assays to evaluate cells within whole tissue, particularly specific types such as the intervertebral disc (IVD). When comparing the reported methodologies and the protocols issued by manufacturers, the processing, working times, and dye concentrations vary significantly, making the assay's reproducibility a costly and time-consuming trial and error process. This study aims to develop a detailed step-by-step cell viability assay protocol for evaluating IVD tissue. IVDs were harvested from bovine tails (n=8) and processed at day 0 and after 7 days of culture. Nucleus pulposus (NP) and the annulus fibrosus (AF) 3 mm cuts were incubated at room temperature (26˚C) with a Viability/Cytotoxicity Kit containing Calcein AM and Ethidium Ethidium homodimer-1 for 2 hr, followed by flash freezing in liquid nitrogen. Thirty µm sections were placed in glass slides and sealed with nail varnish or Antifade Mounting Medium. The IVD tissue was imaged within the next 4h after freezing using an inverted confocal laser-scanning microscope equipped with 488 and 543 nm laser lines. Cell viability at day 0 (NP: 92±9.6 % and AF:80±14.0%) and day 7 (NP: 91±7.9% and AF:76±20%) was successfully maintained and evaluated. The incubation time required is dependent on the working temperatures and tissue thickness. The calcein-AM dye will not be retained in the cells for more than four hours. The specimen preparation and culturing protocol have demonstrated good cell viability at day 0 and after seven days of culture. Processing times and sample preparation play an essential role as the cell viability components in most kits hydrolyse or photobleach quickly. A step-by-step replicable protocol for evaluating the cell viability in IVD will facilitate the evaluation of cell and toxicity-related outcomes of
Polyetheretherketone (PEEK) interbody fusion cages combined with autologous bone graft is the current clinical gold standard treatment for spinal fusion, however, bone graft harvest increases surgical time, risk of infection and chronic pain. We describe novel low-stiffness 3D Printed titanium interbody cages without autologous bone graft and assessed their biological performance in a pre-clinical in vivo interbody fusion model in comparison to the gold standard, PEEK with graft. Titanium interbody spacers were 3D Printed with a microporous (Ti1: <1000μm) and macroporous (Ti2: >1000μm) design. Both Ti1 and Ti2 had an identical elastic modulus (stiffness), and were similar to the elastic modulus of PEEK. Interbody fusion was performed on L2-L3 and L4-L5 vertebral levels in 24 skeletally mature sheep using Ti1 or Ti2 spacers, or a PEEK spacer filled with iliac crest autograft, and assessed at 8 and 16 weeks. We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate. Functional spinal units were
Despite past advances of implant technologies, complication rates of fixations remain high at challenging sites such as the proximal humerus [1]. These may not only be owed to the implant itself but also to dissatisfactory surgical execution of fracture reduction and implant positioning. Therefore, the aim of this study was to quantify the instrumentation accuracy of a highly standardised and guided procedure and its influence on the biomechanical outcome and predicted failure risk. Preoperative planning of osteotomies creating an unstable 3-part fracture and fixation with a locking plate was performed based on CT scans of eight pairs of low-density proximal humerus samples from elderly female donors (85.2±5.4 years). 3D-printed subject-specific guides were used to osteotomise and instrument the samples according to the pre-OP plan. Instrumentation accuracies in terms of screw lengths and orientations were evaluated by comparing post-OP CT scans with the pre-OP plan. The fixation constructs were
Introduction. The main postoperative complications in fixation of ulna shaft fractures are non-union and implant irritation using currently recommended 3.5-mm locking compression plates. An alternative approach using a combination of two smaller plates in orthogonal configuration has been proposed. The aim of this study was to compare the biomechanical properties of a single 3.5-mm locking compression plate versus double plating using one 2.5-mm and one 2.0-mm mandible plate in a human ulna shaft fracture model. Method. Eight pairs human ulnar specimens with a standardized 10-mm fracture gap were pairwise assigned for instrumentation with either a single 3.5-mm plate placed posteriorly, or for double plating using a 2.5-mm and a 2.0-mm mandible plate placed posteriorly under the flexor muscles and laterally under the extensor muscles. All constructs were initially non-destructively
Reorientating pelvic osteotomies are performed to improve femoral head coverage and secondary degenerative arthritis. A rectangular triple pelvic innominate osteotomy (3PIO) is performed in symptomatic cases. However, deciding optimal screw fixation type to avoid complications is questionable. Therefore, this study aimed to investigate the biomechanical behavior of two different acetabular screw configurations used for rectangular 3PIO osteosynthesis. It was hypothesized that bi-directional screw fixation would be biomechanically superior to mono-axial screw fixation technique. A rectangular 3PIO was performed in twelve right-side artificial Hemi-pelvises. Group 1 (G1) had two axial and one transversal screw in a bi-directional orientation. Group 2 (G2) had three screws in the axial direction through the iliac crest. Acetabular fragment was reoriented to 10.5° inclination in coronal plane, and 10.0° increased anteversion along axial plane. Specimens were
Introduction. Pedicle screw loosening in posterior instrumentation of thoracolumbar spine occurs up to 60% in osteoporotic patients. These complications may be alleviated using more flexible implant materials and novel designs that could be optimized with reliable computational modeling. This study aimed to develop and validate non-linear homogenized finite element (hFE) simulations to predict pedicle screw toggling. Method. Ten cadaveric vertebral bodies (L1-L5) from two female and three male elderly donors were scanned with high-resolution peripheral quantitative computed tomography (HR-pQCT, Scanco Medical) and instrumented with pedicle screws made of carbon fiber-reinforced polyether-etherketone (CF/PEEK). Sample-specific 3D-printed guides ensured standardized instrumentation, embedding, and loading procedures. The samples were
The quest for optimal treatment of acute distal tibiofibular syndesmotic disruptions is still in progress. Using suture-button repair devices is one of the dynamic stabilization options, however, they may not be always appropriate for stabilization of length-unstable syndesmotic injuries. Recently, a novel screw-suture repair system was developed to address such issues. The aim of this study was to investigate the performance of the novel screw-suture repair system in comparison to a suture-button stabilization of unstable syndesmotic injuries. Eight pairs of human cadaveric lower legs were CT scanned under 700 N single-leg axial loading in five foot positions – neutral, 15° external/internal rotation and 20° dorsi-/plantarflexion – in 3 different states: (1) pre-injured (intact); (2) injured, characterized by complete syndesmosis and deltoid ligaments cuts simulating pronation-eversion injury types III and IV as well as supination-eversion injury type IV according to Lauge-Hansen; (3) reconstructed, using a screw-suture (FIBULINK, Group 1) or a suture-button (TightRope, Group 2) implants for syndesmotic stabilization, placed 20 mm proximal to the tibia plafond. Following, all specimens were: (1)
The quest for optimal treatment of acute distal tibiofibular syndesmotic disruptions is still in full progress. Using suture-button repair devices is one of the dynamic stabilization options, however, they may not be always appropriate for stabilization of length-unstable syndesmotic injuries. Recently, a novel screw-suture repair system was developed to address such issues. The aim of this study was to investigate the performance of the novel screw-suture repair system in comparison to a suture-button stabilization of unstable syndesmotic injuries. Eight pairs of human cadaveric lower legs were CT scanned under 700 N single-leg axial loading in five foot positions – neutral, 15° external/internal rotation and 20° dorsi-/plantarflexion – in 3 different states: (1) pre-injured (intact); (2) injured, characterized by complete syndesmosis and deltoid ligaments cuts simulating pronation-eversion injury types III and IV, and supination-eversion injury type IV according to Lauge-Hansen; (3) reconstructed, using a screw-suture (FIBULINK, Group 1) or a suture-button (TightRope, Group 2) implants for syndesmotic stabilization, placed 20 mm proximal to the tibia plafond/joint surface. Following, all specimens were: (1)
Massive irreparable rotator cuff tears often lead to superior migration of the humeral head, which can markedly impair glenohumeral kinematics and function. Although treatments currently exist for treating such pathology, no clear choice exists for the middle-aged patient demographic. Therefore, a metallic subacromial implant was developed for the purpose of restoring normal glenohumeral kinematics and function. The objective of this study was to determine this implant's ability in restoring normal humeral head position. It was hypothesized that (1) the implant would restore near normal humeral head position and (2) the implant shape could be optimized to improve restoration of the normal humeral head position. A titanium implant was designed and 3D printed. It consisted of four design variables that varied in both implant thickness (5mm and 8mm) and curvature of the humeral articulating surface (high constraint and low constraint. To assess these different designs, these implants were sequentially assessed in a cadaver-based
Distal radius fractures have an incidence rate of 17.5% among all fractures. Their treatment in case of comminution, commonly managed by volar locking plates, is still challenging. Variable-angle screw technology could counteract these challenges. Additionally, combined volar and dorsal plate fixation is valuable for treatment of complex fractures at the distal radius. Currently, biomechanical investigation of the competency of supplemental dorsal plating is scant. The aim of this study was to investigate the biomechanical competency of double-plated distal radius fractures in comparison to volar locking plate fixation. Complex intra-articular distal radius fractures AO/OTA 23-C 2.1 and C 3.1 were created by means of osteotomies, simulating dorsal defect with comminution of the lunate facet in 30 artificial radii, assigned to 3 study groups with 10 specimens in each. The styloid process of each radius was separated from the shaft and the other articular fragments. In group 1, the lunate facet was divided to 3 equally-sized fragments. In contrast, the lunate in group 2 was split in a smaller dorsal and a larger volar fragment, whereas in group 3 was divided in 2 equal fragments. Following fracture reduction, each specimen was first instrumented with a volar locking plate and non-destructive quasi-static
Previous biomechanical studies of lateral collateral ligament (LCL) injuries and their surgical repair, reconstruction and rehabilitation have primarily relied on gravity effects with the arm in the varus position. The application of torsional moments to the forearm manually in the laboratory is not reproducible, hence studies to date likely do not represent forces encountered clinically. The aim of this investigation was to develop a new