Zong-Xing Chen1, Arun-Kumar Kaliya-Perumal1,2, Chi-Chien Niu1, Jaw-Lin Wang3, Po-Liang Lai1. 1. Department of Orthopaedic Surgery, Bone and Joint Research Center, Chang Gung Memorial Hospital and University College of Medicine, Taoyuan, Taiwan. 2. Department of Orthopaedic Surgery, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Tamil Nadu, India. 3. Institute of Biomedical Engineering, College of Medicine and College of Engineering, National Taiwan University, Taipei, Taiwan.
Abstract
STUDY DESIGN: In vitro biomechanical evaluation of a novel self-adaptive unidirectional ratchet growing rod (RGR) system. OBJECTIVE: The aim of this study was to propose and biomechanically validate a novel RGR construct in vitro using porcine thoracic spines and calculate the tensile force required to elongate the RGR with springs, without springs, and with soft tissue encapsulation (induced in vivo in rabbits). SUMMARY OF BACKGROUND DATA: Literature lacks clear consensus regarding the implant of choice for early-onset scoliosis. Multiple systems are currently available, and each has its own advantages and disadvantages. Therefore, studying novel designs that can credibly accommodate growth and curb deformity progression is of principle importance. METHODS: In vitro biomechanical motion tests were done using six porcine thoracic spines with pedicle screws at T3 and T8. A pure moment of ±5 Nm was loaded in lateral bending (LB) and flexion-extension. Range of motion (ROM) and neutral zone (NZ) of each specimen was determined after connecting the free movable growing rods (FGRs), RGRs, and standard rods (SRs). Tensile tests were done to measure the force required to elongate the RGR with springs, without springs, and with soft tissue encapsulation (induced in vivo in rabbits). RESULTS: Global ROM, implanted T3-T8 ROM, and the NZ of specimens with FGRs and RGRs were significantly higher than that with SRs. The RGRs favored unidirectional elongation in both LB and flexion. The tensile forces required for elongating the RGR without springs, with springs, and with soft tissue capsulation (by a scaled unit of 3 mm) were 3 ± 1.3 N, 10.5 ± 0.4 N, and 48.4 ± 14.4 N, respectively. CONCLUSION: The RGR could stabilize and favor unidirectional elongation of the implanted spinal column when appropriate forces were present. There was no device failure as far as we have studied and it is anticipated that, with further safety and feasibility assessment, RGRs could be adapted for clinical use. LEVEL OF EVIDENCE: N/A.
STUDY DESIGN: In vitro biomechanical evaluation of a novel self-adaptive unidirectional ratchet growing rod (RGR) system. OBJECTIVE: The aim of this study was to propose and biomechanically validate a novel RGR construct in vitro using porcine thoracic spines and calculate the tensile force required to elongate the RGR with springs, without springs, and with soft tissue encapsulation (induced in vivo in rabbits). SUMMARY OF BACKGROUND DATA: Literature lacks clear consensus regarding the implant of choice for early-onset scoliosis. Multiple systems are currently available, and each has its own advantages and disadvantages. Therefore, studying novel designs that can credibly accommodate growth and curb deformity progression is of principle importance. METHODS: In vitro biomechanical motion tests were done using six porcine thoracic spines with pedicle screws at T3 and T8. A pure moment of ±5 Nm was loaded in lateral bending (LB) and flexion-extension. Range of motion (ROM) and neutral zone (NZ) of each specimen was determined after connecting the free movable growing rods (FGRs), RGRs, and standard rods (SRs). Tensile tests were done to measure the force required to elongate the RGR with springs, without springs, and with soft tissue encapsulation (induced in vivo in rabbits). RESULTS: Global ROM, implanted T3-T8 ROM, and the NZ of specimens with FGRs and RGRs were significantly higher than that with SRs. The RGRs favored unidirectional elongation in both LB and flexion. The tensile forces required for elongating the RGR without springs, with springs, and with soft tissue capsulation (by a scaled unit of 3 mm) were 3 ± 1.3 N, 10.5 ± 0.4 N, and 48.4 ± 14.4 N, respectively. CONCLUSION: The RGR could stabilize and favor unidirectional elongation of the implanted spinal column when appropriate forces were present. There was no device failure as far as we have studied and it is anticipated that, with further safety and feasibility assessment, RGRs could be adapted for clinical use. LEVEL OF EVIDENCE: N/A.