Observed Length Increases of Magnetically Controlled Growing Rods are Lower Than Programmed.

BACKGROUND: Magnetically controlled growing rods (MCGRs) are increasingly used in the treatment of early onset scoliosis (EOS). Few studies have reported whether desired lengthening can reliably be achieved, or if prior spine instrumentation and large tissue depths affect lengthening. In this clinical study of EOS patients, it was hypothesized that increases in rod length would equal programmed increases, patients with prior spine instrumentation would lengthen less than patients without prior surgery, and larger tissue depths would decrease lengthening success. METHODS: A retrospective chart review was conducted on EOS patients with single and dual MCGRs placed between April 2014 to September 2015 and distracted at a single institution. Rod distraction was measured at each visit using ultrasound. Differences between programmed and actual distraction for each patient, and between groups with and without prior spine instrumentation, were determined by 2-tailed t tests. Regression and correlation were used to determine the relationship between tissue depth and length increases. RESULTS: Thirty-one patients were included, 18 males, 13 females, age 8.1 (±2.5) years, with major curves measuring 60 (±14.6) degrees at time of MCGR insertion. In the 12 patients with prior instrumentation, time from initial growing rod placement to MCGR insertion was 23.1 (±10.6) months. The number of surgical procedures before MCGR insertion was 2.8 (±2.0). Total length increase relative to the programmed distraction was 86% (±21) (P<0.001). Length increases for patients with and without prior surgery were 87% (±23) and 86% (±19), respectively (P>0.9). Total lengthening was inversely proportional to tissue depth (r=0.38, P<0.01); the decrease in lengthening achieved was 2.1%/mm of tissue depth. CONCLUSIONS: Increases in rod length were 14% lower than the programmed distraction. Prior instrumentation did not impact the amount of rod distraction. Greater distance between the rod and the skin surface negatively affected the magnitude of distraction.

Scoliosis vertebral growth plate histomorphometry: Comparisons to controls, growth rates, and compressive stresses.

Scoliosis progression in skeletally immature patients depends on remaining growth. Relationships between vertebral growth plate histomorphometry, growth rates, and mechanical stresses have been reported in several animal studies. Hypertrophic zone heights and chondrocyte heights have been used to assess treatments that aim to modulate growth. The purpose of this study was to determine whether human vertebral physeal hypertrophic zone and cell heights differed between two groups: Severe scoliosis and autopsy controls. Severity was defined at time of surgical planning by curve magnitude and curve stiffness. Physeal samples were obtained from the convex side apex, and from the concave side when feasible. Histologic sections were prepared, and digital images were used to measure hypertrophic zone height, cell height, and cell width. Thirteen spinal deformity patients were included, mean curve magnitude 67° (±23). Etiologies were juvenile and adolescent idiopathic, congenital, neurofibromatosis, neuromuscular, and Marfan syndrome. Five age-matched autopsy specimens without scoliosis served as controls. Results were presented by etiology, then all convex scoliosis specimens were combined and compared to controls. Zone heights for scoliosis, convex side, and controls were 152 µm (±34) and 180 µm (±42) (p = 0.21), cell heights 8.5 µm (±1.1) and 12.8 µm (±1.2) (p < 0.0005), and cell widths 14.9 µm (±1.5) and 15.0 µm (±2.5), respectively. Human values were compared to published animal models and to a quantitative theory of a stress ̶ growth curve. This quantification of vertebral physeal structures in scoliosis may be expected to help assess theories of progression and potential treatments using growth modulation. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:2450-2459, 2018.

Antegrade versus retrograde titanium elastic nail fixation of pediatric distal-third femoral-shaft fractures: a mechanical study.

OBJECTIVES: To determine whether the stability of elastic stable intramedullary nail (ESIN) constructs differ in terms of antegrade versus retrograde insertion for the fixation of pediatric distal-third transverse femoral-shaft fractures. METHODS: Ten synthetic composite adolescent-sized femur models and 20 flexible titanium (Ti) intramedullary (IM) nails were divided into antegrade and retrograde groups. A simulated transverse fracture was created in each of 10 models in the distal-third region of the shaft (more precisely near the distal fifth). The fractures were then stabilized with ESIN. The specimens were subjected to four-point bending and then axial torsion. Flexural forces were applied to the medial aspect of the model across the fracture site at a rate of 0.05 mm/s to a maximum displacement of 3.7 mm (7 degrees). Torsional moments were applied to the distal aspect of the model in internal and external rotation at a rate of 0.75 degrees/s to a maximum of 10 degrees. Loads and stiffnesses were determined between consistent displacement limits; differences were compared using t tests (alpha = 0.05, two tailed). RESULTS: Flexural stiffness was significantly greater in the retrograde group (350 +/- 72 N/mm) compared with antegrade (195 +/- 95 N/mm; P = 0.02). A 66-kg load placed across the fracture displaced the site 3.7 mm for the antegrade group, whereas the retrograde group required a load 89% greater (125 kg). Although torsional stiffness tended to be greater in the antegrade group, the differences were not statistically significant (P = 0.2). CONCLUSIONS: Although the recommendation for distal-third femur fractures is antegrade nail insertion, this study demonstrates that given satisfactory cortical starting points in the distal fragment, retrograde insertion provides greater stability. These mechanical testing data are the first to address this specific fracture scenario and may aid surgical decision making.

Repetitive Stresses Generate Osteochondral Lesions in Skeletally Immature Rabbits.

BACKGROUND: The origin of juvenile osteochondritis dissecans (OCD) is unknown. Existing experimental animal models of OCD most frequently involve surgically created lesions but do not examine repetitive stress as a possible cause of OCD. HYPOTHESIS: Repetitive stresses can cause OCD-like lesions in immature animals. STUDY DESIGN: Controlled laboratory study. METHODS: Six juvenile rabbits were subjected to repetitive loading forces of approximately 160% body weight to the right hindlimb during five 45-minute sessions per week for 5 weeks. The contralateral limb was the unloaded control. After 5 weeks, rabbits were euthanized and examined with radiographs, micro-computed tomography, and gross and histopathologic analysis. RESULTS: All 6 rabbits developed osteochondral lesions in loaded limbs on the medial and lateral femoral condyles, while contralateral unloaded limbs did not demonstrate lesions. Loaded limbs developed relative osteopenia in the femoral epiphysis and tibial metaphysis with associated decreased trabecular density. Loaded limbs also demonstrated increased femoral subchondral bone thickness near the lesions. Lesions did not have grossly apparent extensive articular cartilage damage; however, cartilage thickness increased on histology with reduced ossification. Loaded knees demonstrated abundant chondrocyte cloning, limited cartilage fissuring, and a focal loss of cellularity at the articular surface. CONCLUSION: Low-grade lesions in human OCD have little gross articular cartilage involvement despite substantial changes to the subchondral bone as shown on magnetic resonance imaging and radiographs. Histopathology findings in this study included cartilage thickening and chondrocyte cloning resembling those of recently published human OCD biopsy studies. Our animal model supports the hypothesis that repetitive stress to immature knees may contribute to the development of human OCD. This model may be useful in understanding the pathophysiology and healing of human OCD. CLINICAL RELEVANCE: Repetitive physiologic stress generated changes to the subchondral bone in immature animals without causing extensive articular damage. The similarities of these lesions in gross and histologic appearance with human OCD support repetitive stress as the likely the cause for human OCD.

Flexible growing rods: a biomechanical pilot study of polymer rod constructs in the stability of skeletally immature spines.

BACKGROUND: Surgical treatments for early onset scoliosis (EOS) correct curvatures and improve respiratory function but involve many complications. A distractible, or 'growing rod,' implant construct that is more flexible than current metal rod systems may sufficiently correct curves in small children and reduce complications due to biomechanical factors. The purpose of this pilot study was to determine ranges of motion (ROM) after implantation of simulated growing rod constructs with a range of clinically relevant structural properties. The hypothesis was that ROM of spines instrumented with polymer rods would be greater than conventional metal rods and lower than non-instrumented controls. METHODS: Biomechanical tests were conducted on six thoracic spines from skeletally immature domestic swines (35-40 kg). Paired pedicle screws were used as anchors at proximal and distal levels. Specimens were tested under the following conditions: control, then dual rods of polyetheretherketone (PEEK) (diameter 6.25 mm), titanium (4 mm), and cobalt-chrome alloy (CoCr) (5 mm). Lateral bending (LB) and flexion-extension (FE) moments were applied, and vertebral rotations were measured. Differences were determined by two-tailed t-tests and Bonferroni for four primary comparisons: PEEK vs control and PEEK vs CoCr, in LB and FE (α = 0.05/4). RESULTS: In LB, ROM of spine segments after instrumenting with PEEK rods was lower than the non-instrumented control condition at each instrumented level. ROM was greater with PEEK rods than with Ti and CoCr rods at every instrumented level. Combining treated levels, in LB, ROM for PEEK rods was 35 % of control (p < 0.0001) and 270 % of CoCr rods (p < 0.01). In FE, ROM with PEEK was 27 % of control (p < 0.001) and 180 % of CoCr (p < 0.01). At proximal and distal adjacent non-instrumented levels in FE, mean ROM was lower for PEEK than for either metal. CONCLUSIONS: PEEK rods increased flexibility versus metal rods, and decreased flexibility versus non-instrumented controls, both over the entire instrumented segment and at each individual level. Smaller mean increases in ROM at proximal and distal adjacent motion segments occurred with PEEK compared to metal rods, which may help decrease complications, such as junctional kyphosis. Flexible growing rods may eventually help improve treatment options for young patients with severe deformity.

Flexible growing rods: a pilot study to determine if polymer rod constructs may provide stability to skeletally immature spines.

BACKGROUND: Surgical treatments for early onset scoliosis (EOS), including growing rod constructs, involve many complications. Some are due to biomechanical factors. A construct that is more flexible than current instrumentation systems may reduce complications. The purpose of this preliminary study was to determine spine range of motion (ROM) after implantation of simulated growing rod constructs with a range of clinically relevant structural properties. The hypothesis was that ROM of spines instrumented with polyetheretherketone (PEEK) rods would be greater than metal rods and lower than noninstrumented controls. Further, adjacent segment motion was expected to be lower with polymer rods compared to conventional systems. METHODS: Biomechanical tests were conducted on 6 skeletally immature porcine thoracic spines (domestic swine, 35-40 kg). Spines were harvested after death from swine that had been utilized for other studies (IACUC approved) which had not involved the spine. Paired pedicle screws were used as anchors at proximal and distal levels. Specimens were tested under the following conditions: control, then dual rods of PEEK (6.25 mm), titanium (4 mm), and CoCr (5 mm) alloy. Lateral bending (LB) and flexion-extension (FE) moments of ±5 Nm were applied. Vertebral rotations were measured using video. Differences were determined by two-tailed t-tests and Bonferroni correction with four primary comparisons: PEEK vs control and PEEK vs CoCr, in LB and FE (α=0.05/4). RESULTS: In LB, ROM of specimens with PEEK rods was lower than control at each instrumented level. ROM was greater for PEEK rods than both Ti and CoCr at every instrumented level. Mean ROM at proximal and distal noninstrumented levels was lower for PEEK than for Ti and CoCr. In FE, mean ROM at proximal and distal noninstrumented levels was lower for PEEK than for metal. Combining treated levels, in LB, ROM for PEEK rods was 35% of control (p<0.0001) and 270% of CoCr rods (p<0.01). In FE, ROM with PEEK was 27% of control (p<0.001) and 180% of CoCr (p<0.01). CONCLUSIONS: PEEK rods decreased flexibility versus noninstumented controls, and increased flexibility versus metal rods. Smaller increases in ROM at proximal and distal adjacent motion segments occurred with PEEK compared to metal rods, which may help decrease junctional kyphosis. Flexible growing rods may eventually help improve treatment options for young patients with severe deformity.

Transverse process hooks at upper instrumented vertebra provide more gradual motion transition than pedicle screws.

STUDY DESIGN: Biomechanical study in a porcine model. OBJECTIVE: To determine whether transverse process hooks (TPHs) placed at the proximal end of a long posterior spinal fusion construct provide a more gradual transition to normal motion of the adjacent cephalad motion segment compared with an all pedicle screw (APS) construct. SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis after instrumentation with long posterior spinal constructs has been increasingly associated with incidence of adjacent segment pathologies. Clinical studies have suggested that proximal anchor type may affect the incidence of proximal junctional kyphosis. METHODS: Biomechanical tests were conducted on porcine thoracic spines before and after implantation of a long spinal fusion construct. In all specimens, dual long rods (Co-Cr) were implanted posteriorly using pedicle screws at T7-T15. Upper instrumented vertebra, T6, received either TPHs (n = 7) or pedicle screws (APSs) (n = 6). Each specimen was tested in flexion-extension then lateral bending. Moments were applied, and vertebral displacements were recorded. Range of motion (ROM) and stiffness (K) were determined for each motion segment. Differences between TPH and APS at the transition were determined using t tests. RESULTS: In flexion-extension, ROM at the most proximal instrumented motion segment was 9% of control for APS versus 21% of control for TPH. Difference between APS and TPH at UIV was 0.5° (P < 0.008). Stiffness of TPH at T6-T7 was significantly lower than APS in FE (P < 0.003). For APS, the greatest mean ROM occurred at the first uninstrumented segment, whereas TPH maintained the pattern of monotonic increases in mean ROM from distal to proximal. CONCLUSION: TPHs at the upper instrumented vertebra provided a more gradual transition to normal motion compared with pedicle screws in long posterior spinal fusion constructs. TPH at the upper instrumented vertebra may be postulated to decrease the incidence of postoperative proximal junctional kyphosis compared with APS. LEVEL OF EVIDENCE: N/A.

Biomechanics of spinal hemiepiphysiodesis for fusionless scoliosis treatment using titanium implant.

STUDY DESIGN: In vitro study of the effect of hemiepiphyseal implant on biomechanical properties of porcine thoracic motion segments. OBJECTIVE: Determine whether implantation of a titanium clip-screw construct alters spine biomechanical properties. SUMMARY OF BACKGROUND DATA: Growth modification is under investigation as a treatment of early adolescent idiopathic scoliosis. Biomechanical property changes due to device implantation are essential to characterize immediate postoperative treatment effects. METHODS: In vitro biomechanical tests were conducted on 18 thoracic functional spinal units. Specimens were tested before and after implantation of a clip-screw construct in lateral bending, flexion-extension, or axial rotation (n = 6 per loading direction). Pure moments were applied, and range of motion, stiffness, and neutral zone were measured. Axial translations were determined bilaterally. RESULTS: Implantation of the clip-screw construct decreased range of motion in lateral bending by 19% (P < 0.0003), flexion-extension by 11% (P < 0.04), and axial rotation by 8%. Mean stiffness in lateral bending toward and away from the treated side increased by 20% (P < 0.007) and 33%, respectively. In flexion and extension, mean stiffness increased by 10% and 16%, respectively. Treatment decreased the neutral zone in lateral bending toward and away from the instrumented side by 30% (P < 0.0003) and 47% (P < 0.02), respectively. In flexion and extension, neutral zone decreased by 20% (P < 0.04) and 26% (P < 0.007), respectively. In axial rotation toward and away from the treated side, mean neutral zone decreased by 22% (P < 0.04) and 7%, respectively. Range of axial translation decreased on the ipsilateral side by 49% (P < 0.001) and increased on the contralateral side by 17%. CONCLUSION: Implantation of a titanium clip-screw construct decreased range of motion by less than one-fifth, increased stiffness by one-third or less, and decreased the neutral zone by less than one-half. Range of axial translation decreased on the instrumented side and increased contralaterally. This study suggests that most of the flexibility of the spine is preserved in the immediate postoperative period after implantation of the spinal hemiepiphyseal construct.

In vivo dynamic compressive stresses in the disc annulus: a pilot study of bilateral differences due to hemiepiphyseal implant in a quadruped model.

STUDY DESIGN: In vivo biomechanical study in quadruped model. OBJECTIVE: To develop in vivo model capable of determining physiological compressive stresses bilaterally in the intervertebral disc annulus and preliminarily assess effects of a hemiepiphyseal implant. SUMMARY OF BACKGROUND DATA: Spine growth modification alters stress distributions in vertebral growth plates and discs. Quantification of stresses is required to help assess implant efficacy and disc health. More generally, despite widespread and necessary use of animals in preclinical studies of spine instrumentation, limited quantitative information is available on mechanobiological conditions in quadruped spines for comparisons with those of humans. METHODS: Skeletally immature domestic pigs were instrumented with an implant and 4 stress sensors. Sensors were inserted into left and right sides of the annulus at 2 thoracic levels. A titanium staple-screw construct was implanted at 1 level. Signals were acquired intraoperatively, postoperatively during normal activities, and biweekly with the animal under anesthesia, for up to 8 weeks. RESULTS: Stresses varied by sensor location relative to implant, postoperative time, activity, and animal. Intraoperatively, the mean peak stress due to staple insertion was 1.6 MPa at the sensor nearest the staple. Mean stress at the end of surgery was 0.23 MPa. Mean stress standing the first day was 0.38 MPa. Dynamic stresses were recorded at all locations, including the location nearest the staple. Highest mean stresses were those nearest the implant. With the animal under anesthesia, the dynamic stress range in the resting prone position was 0.1 MPa, whereas this range was 0.9 MPa when the spine was manually flexed. CONCLUSION: Compressive stresses were dynamic at both control and stapled levels, which indicated that the disc was not immobilized by the implant. These pilot results suggested that mean disc compression was increased within the first postoperative week. Stresses ranged up to levels measured in humans.

Implantable MEMS compressive stress sensors: Design, fabrication and calibration with application to the disc annulus.

Physiological stresses are fundamental to biomechanical testing, mechanobiological analyses, implant design, and tissue engineering. The purpose of this study was to design, fabricate, and evaluate compressive stress sensors packaged for extended, in vivo implantation in the annulus of the intervertebral disc. A commercial microelectromechanical systems (MEMS) pressure sensor die was selected as the active element for a custom stress sensor. The sensor die was modified and packaged to protect the electrical system from the biochemical and biomechanical environment. Completed sensors were calibrated under hydrostatic pressure and solid contact compression. Calibrations were performed before and after 8 weeks of in vivo implantation in a porcine disc. For the two reported sensors, stress and voltage were linearly correlated over a range of 0-1.8 MPa with less than 5% change in sensitivity. Sensitivity to solid contact stress was within 10% of that from hydrostatic pressure. In contrast to most previous studies, in which disc pressure was measured in the fluidic nucleus pulposus, these sensors may be used to measure in vivo dynamic compressive stresses in the annulus at magnitudes typical of the musculoskeletal system in a large animal over a relatively long post-operative time.

Spinal hemiepiphysiodesis decreases the size of vertebral growth plate hypertrophic zone and cells.

BACKGROUND: Hemiepiphysiodesis is a potential method to treat idiopathic juvenile scoliosis early. The purpose of the present study was to investigate a mechanism of curve creation in the pig thoracic model of spinal hemiepiphysiodesis by determining whether the structure of the vertebral growth plate varied with distance from the stapled, concave side of the spine. The hypotheses were that the heights of the hypertrophic zone, hypertrophic cells, and disc would be decreased on the treated side of the treated level as compared with both an unstapled control level and the side opposite the staple. METHODS: Custom spine staples were implanted into six midthoracic vertebrae in each of five skeletally immature pigs. After eight weeks, the spines were harvested and histological sections were prepared. Hypertrophic zone height, hypertrophic cell height and width, and disc height were measured at discrete coronal plane locations at stapled and unstapled thoracic levels. Differences between stapled and unstapled levels and locations were compared with use of mixed linear modeling for repeated measures, followed by regression models to determine growth plate intercept and slope across the plane by thoracic level. RESULTS: Zone height, cell height, and cell width were lowest on the stapled side of the stapled level, with significant differences in the overall statistical model (p < 0.02). Disc heights were significantly reduced (p < 0.0001) at the stapled levels across the coronal plane. CONCLUSIONS: Unilateral control of intervertebral joint motion decreased growth plate height, cell size, and disc height.