Innovative hydrogel-patch combination for large annulus fibrosus defects: a prospective approach to address herniation recurrence.

BACKGROUND CONTEXT: Large annulus fibrosus (AF) defects often lead to a high rate of reherniation, particularly in the medial AF region, which has limited self-healing capabilities. The increasing prevalence of herniated discs underscores the need for effective repair strategies. PURPOSE: The objectives of this study were to design an AF repair technique to reduce solve the current problems of insufficient mechanical properties and poor sealing capacity. STUDY DESIGN: In vitro biomechanical experiments and finite element analysis. METHODS: The materials used in this study were patches and hydrogels with good biocompatibility and sufficient mechanical properties to withstand loading in the lumbar spine. Five repair techniques were assessed in this study: hydrogel filler (HF), AF patch medial barrier (MB), AF patch medial barrier and hydrogel filler (MB&HF), AF patch medial-lateral barrier (MLB), and AF patch medial-lateral barrier and hydrogel filler (MLB&HF). The repair techniques were subjected to in vitro testing (400 N axial compression and 0-500 N fatigue loading at 5Hz) and finite element analysis (400 N axial compression) to evaluate the effectiveness at repairing large AF defects. The evaluation included repair tightness, spinal stability, and fatigue resistance. RESULTS: From the in vitro testing, the failure load of the repair techniques was in the following order HF MLB >MB&HF >MLB&HF. CONCLUSIONS: The combined use of patches and hydrogels exhibited promising mechanical properties postdiscectomy, providing a promising solution for addressing large AF defects and improving disc stability. CLINICAL SIGNIFICANCE: This study introduces a promising method for repairing large annular fissure (AF) defects after disc herniation, combining patch repair with a hydrogel filler. These techniques hold potential for developing clinical AF repair products to address this challenging issue.

Biomechanical evaluation of a novel intervertebral disc repair technique for large box-shaped ruptures.

Objective: The purpose of this study was to analyze the feasibility of repairing a ruptured intervertebral disc using a patch secured to the inner surface of the annulus fibrosus (AF). Different material properties and geometries for the patch were evaluated. Methods: Using finite element analysis, this study created a large box-shaped rupture in the posterior-lateral region of the AF and then repaired it with a circular and square inner patch. The elastic modulus of the patches ranged from 1 to 50 MPa to determine the effect on the nucleus pulposus (NP) pressure, vertical displacement, disc bulge, AF stress, segmental range of motion (ROM), patch stress, and suture stress. The results were compared against the intact spine to determine the most suitable shape and properties for the repair patch. Results: The intervertebral height and ROM of the repaired lumbar spine was similar to the intact spine and was independent of the patch material properties and geometry. The patches with a modulus of 2-3 MPa resulted in an NP pressure and AF stresses closest to the healthy disc, and produced minimal contact pressure on the cleft surfaces and minimal stress on the suture and patch of all models. Circular patches caused lower NP pressure, AF stress and patch stress than the square patch, but also caused greater stress on the suture. Conclusion: A circular patch with an elastic modulus of 2-3 MPa secured to the inner region of the ruptured annulus fibrosus was able to immediately close the rupture and maintain an NP pressure and AF stress similar to the intact intervertebral disc. This patch had the lowest risk of complications and produced the greatest restorative effect of all patches simulated in this study.

Treatment of Lumbar Degenerative Disease with a Novel Interlaminar Screw Elastic Spacer Technique: A Finite Element Analysis.

A novel interlaminar elastic screw spacer technique was designed to maintain lumbar mobility in treating lumbar degenerative diseases. A validated finite element model of L4/5 was used to establish an ISES-1/2 model and an ISES-1/3 model based on different insertion points, a unilateral fixation model and a bilateral fixed model based on different fixation methods, and a Coflex-F model based on different implants. The elastic rods were used to fix screws. Under the same mechanical conditions, we compared the biomechanical characteristics to investigate the optimal entry point for ISES technology, demonstrate the effectiveness of unilateral fixation, and validate the feasibility of the ISES technique. Compared to ISES-1/3, the ISES-1/2 model had lower intradiscal pressure, facet cartilage stress, and posterior structural stress. Compared to the ISES-BF model, the ISES-UF model had lower intervertebral pressure, larger mobility, and smaller stress on the posterior structures. The ISES model had a similar intervertebral pressure and limitation of extension as the Coflex-F model. The ISES model retained greater mobility and reduced the stress on the facet cartilage and posterior structure compared with the Coflex-F model. Our study suggests that the ISES technique is a promising treatment of lumbar degenerative diseases, especially those with osteoporosis.

Correlation between component alignment and short-term clinical outcomes after total knee arthroplasty.

Objective: This study aimed to investigate the correlation between component alignment and short-term clinical outcomes after total knee arthroplasty (TKA). Methods: 50 TKA patients from a regional hospital were enrolled in the study. The following component alignments were measured from radiological data acquired within 1 week after surgery: hip-knee-ankle angle (HKA), medial distal femoral angle (MDFA), medial proximal tibial angle (MPTA), femoral flexion-extension angle (FEA), tibial slope angle (TSA), femoral rotational angle (FRA) and tibial rotational angle (TRA). The Hospital for Special Surgery (HSS) knee scoring system was used to assess clinical outcomes after 1 year, with patients being divided into three groups (excellent, good and not good) according to the HSS scores. Difference analysis and linear correlation analysis were used for the statistical analysis. Results: The results showed significant differences in MDFA (p = 0.050) and FEA (p = 0.001) among the three patient groups. It was also found that the total HSS had only a moderate correlation with FEA (r = 0.572, p < 0.001), but FEA had a positive linear correlation with pain scores (r = 0.347, p = 0.013), function scores (r = 0.535, p = 0.000), ROM scores (r = 0.368, p = 0.009), muscle scores (r = 0.354, p = 0.012) and stability scores (r = 0.312, p = 0.028). A larger MDFA was associated with lower FE deformity scores (r = -0.289, p = 0.042) and the TSA had a positive influence on the ROM (r = 0.436, p = 0.002). Also, changes in FRA produced a consequent change in the FE deformity score (r = 0.312, p = 0.027), and the muscle strength scores increased as TRA increased (r = 0.402, p = 0.004). Conclusion: The results show that the FEA plays a significant role in clinical outcomes after TKA. Surgical techniques and tools may need to be improved to accurately adjust the FEA to improve joint functionality and patient satisfaction.

A Strong Correlation Between the Severity of Flatfoot and Symptoms of Knee Osteoarthritis in 95 Patients.

Objective: The purpose of this study is to assess the association between the presence and severity of flatfoot and symptoms of knee OA. Methods: 95 participants with knee OA were recruited from a patient cohort at a regional hospital. Symptoms of knee OA, including knee degeneration, femorotibial alignment, pain, stiffness and dysfunction were assessed using the Kellgren-Lawrence (K-L) grading system, femoral-tibial angle (FTA), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Participants were divided into groups with flatfoot (mild, moderate and severe) and without flatfoot based on the Clarke's angle. Linear regression and ordinal logistic regression were used for statistical analysis, as appropriate. Results: Having flatfoot was associated with a significantly increased risk of having a higher K-L grade (OR: 20.03; 95% CI, 5.88, 68.27; p < 0.001), smaller FTA (Beta: -2.96; 95% CI, -4.41, -1.50; p < 0.001), higher pain score (Beta: 0.47; 95% CI, 0.24, 0.69; p < 0.001) and greater loss of function (Beta: 0.25; 95% CI, 0.02, 0.48; p = 0.03). Severe grades of flat feet were associated with a higher K-L grade (OR: 0.19; 95% CI, 0.08, 0.44; p < 0.001), smaller FTA (Beta: 1.51; 95% CI, 0.66, 2.35; p = 0.001), higher pain score (Beta: -0.25; 95% CI, -0.39, -0.11; p = 0.001), greater stiffness (Beta: -0.24; 95% CI, -0.38, -0.09; p = 0.002) and greater loss of function (Beta: -0.27; 95% CI, -0.41, -0.14; p < 0.001). Conclusion: The results indicated that the severity of flattening is significantly associated with symptoms of knee OA. For the conservative management of knee OA, both flatfoot and its severity should be carefully considered.

Biomechanical evaluation of a short-rod technique for lumbar fixation surgery.

Objective: The purpose of this study was to analyze the stability and instrument-related complications associated with fixation of the lumbar spine using the Short-Rod (SR) technique. Methods: Using finite element analysis, this study assessed the stability of a bilateral lumbar fixation system when inserting the pedicle screws at angles of 10°, 15°, and 20° to the endplate in the sagittal plane. Using the most stable construct with a screw angle, the model was then assessed with different rod lengths of 25, 30, 35, and 45 mm. The optimal screw inclination angle and rod length were incorporated into the SR model and compared against traditional parallel screw insertion (pedicle screws in parallel to the endplate, PPS) in terms of the stability and risk of instrument-related complications. The following parameters were evaluated using the validated L4-L5 lumbar finite element model: axial stiffness, range of motion (ROM), stress on the endplate and facet joint, von-Mises stress on the contact surface between the screw and rod (CSSR), and screw displacement. Results: The results showed that the SR model with a 15° screw inclination angle and 35 mm rod length was superior in terms of construct stability and risk of complications. Compared to the PPS model, the SR model had lower stiffness, lower ROM, less screw displacement, and lower stress on the facet cartilage, the CSSR, and screws. However, the SR model also suffered more stress on the endplate in flexion and lateral bending. Conclusion: The SR technique with a 15° screw inclination and 35 mm rod length offers good lumbar stability with a low risk of instrument-related complications.

Association Between the Morphology of Proximal Tibiofibular Joint and the Presence of Knee OA.

Objective: The aim of this study was to evaluate the association between the morphology of the proximal tibiofibular joint (PTFJ) and the presence of knee osteoarthritis (OA). Methods: Twenty-eight OA subjects and 30 healthy subjects were enrolled in this study. A 3D model of the lower limb of each subject was constructed from CT scans and used to measure the characteristics of the PTFJ, including the shape of the articular facets, articular surface area, joint inclination, relative articular height, and joint declination. The association between the characteristics of the PTFJ and presence of knee OA was assessed using binomial logistic regression analysis. Results: There was a significant difference between the OA and healthy groups in terms of the inclination (p = 0.028) and declination (p = 0.020) of the PTFJ and relative articular height (p = 0.011). A greater inclination angle (OR: 1.463, 95% CI: 1.124-1.582, p = 0.021), greater declination angle (OR: 1.832, 95% CI: 1.691-2.187, p = 0.009), and lower relative articular height (OR: 0.951, 95% CI: 0.826-0.992, p = 0.008) were found to be associated with an increased likelihood of knee OA being present. Conclusion: The results of this study suggest that abnormal PTFJ morphology is associated with the presence of knee OA.

Challenges of pre-clinical testing in orthopedic implant development.

The market for orthopedic implants is growing rapidly with the increasing prevalence of orthopedic diseases in an aging society. Different designs and materials have been developed over the years and have, in general, shown excellent results in pre-clinical testing. However, there have been incidences of serious complications when novel implants or materials are put into clinical use, with some well-known cases being metallosis in patients implanted with metal-on-metal hip replacements and osteolysis from polyethylene wear debris generated in hip and knee joint replacements. Unforeseen factors related to new designs, materials and surgical techniques can lead to different outcomes for pre-clinical testing and clinical use. While often an excellent indicator of a device's performance in clinical settings, pre-clinical testing does sometime fail to predict critical flaws in implant development. This article aims to explore the gaps in the current approach to testing. The ISO international standard of pre-clinical testing should be modified to more adequately capture actual clinical use of the implant and simulate daily activities. This article will also introduce modern methods for implant development, such as FEM, 3D printing and computer-aided orthopedic surgery, which can be widely applied to improve pre-clinical testing procedures and reduce the incidence of surgical malalignment by analyzing biomechanical performance, planning surgical procedure and providing surgical guide.