Ideal length of accessory rod for the prevention of rod fracture after pedicle subtraction osteotomy in adult spinal deformity: short or long?

OBJECTIVE: Pedicle subtraction osteotomy (PSO) is an effective surgical procedure for adult spinal deformity (ASD). However, the complexity of the procedure and its associated complications including rod fracture (RF) remain challenging issues. Among several RF reduction methods, the accessory rod (AR) is an important surgical technique. To date, knowledge about the ideal length and configuration of the AR is limited. This study aimed to assess the influence of the connection levels and configuration of the AR on RF occurrence in patients with ASD who underwent long level constructs and PSO. METHODS: The authors retrospectively selected 57 consecutive patients (mean age 70.6 years) who underwent deformity correction including PSO and the AR technique with a minimum 2-year follow-up. The patients were classified into a non-RF group (n = 49) and an RF group (n = 8). Along with analysis of patient and radiological factors in the 2 groups, comparative studies were performed including configuration of the AR (D shaped vs linear shaped) and the connection levels of AR (long AR [the lower end below S1-2] vs short AR [above L5-S1]). RESULTS: The overall rate of RF incidence was 14% (8/57 cases) at an average of 42.5 months (2 patients with unilateral RF and 6 with bilateral RF). RF occurred most commonly at the L4-5 level, below the lower end of the AR: 6 below the lower end of the AR and 2 at the PSO site. There were no significant differences in patient and radiological factors between the groups. Comparisons between the 2 groups indicated that more RFs occurred when the configuration of the AR was a linear shape (p = 0.016) and when the distal end of the AR was above L5-S1 (p = 0.025). CONCLUSIONS: In this study the authors found that the D-shaped configuration of the AR and lower end of the AR below S1-2 (i.e., long AR) could be preventive methods for reducing RF after deformity correction performed using PSO and the AR technique for ASD. Here, the authors have provided the first comprehensive outline for the AR technique. These findings could establish effective guidelines for spine surgeons.

Costal chondrocyte-derived pellet-type scaffold-free autologous chondrocyte implantation provided acceptable mid-term outcomes in osteochondral defects with up to 10-mm depth.

PURPOSE: To evaluate clinical, radiographic, and magnetic resonance (MR) results of costal chondrocyte-derived pellet-type scaffold-free autologous chondrocyte implantation (CCP-ACI) in osteochondral defects (ODs) up to 10-mm depth during 5 years of follow-up. METHODS: Ten patients with CCP-ACI performed in ODs with depth up to 10 mm were retrospectively analyzed. The minimum follow-up period was 5 years. The median age was 36.5 (range 20-55) years. The median size and the depth of the OD lesion were 4.25 cm2 (range 2-6) and 7.0 mm (6-9), respectively. Clinically, the International Knee Documentation Committee, Lysholm, and visual analog scale pain scores were evaluated. Radiographically, the hip‒knee‒ankle (HKA) angle and the Kellgren‒Lawrence (K‒L) grade were assessed. On MR imaging, the magnetic resonance observation of cartilage repair tissue (MOCART) 2.0 score and the defect depth were evaluated. RESULTS: All average clinical scores improved significantly by 1, 2, and 5 years postoperatively. The average HKA angle and the proportion of K‒L grade did not change significantly within 5 years. The median total MOCART scores were 50 (range 45-65), 50 (35-90), 57.5 (40-90), and 65 (50-85) at 6 months, 1 year, 2 years, and 5 years postoperatively, respectively (p = 0.001), with significant improvement at 2 years compared to that at 6 months postoperatively. The signal intensity of the repair tissue and subchondral change significantly improved from 10 (range 10-10) to 12.5 (10-15) (p = 0.036), and from 10 (10-10) to 17.5 (0-20) (p = 0.017), respectively. Significant improvements were seen at 5 years postoperatively for the former and at 2 years postoperatively for the latter. The average depths on MR imaging were 6.7, 6.7, 6.8, 6.6, and 6.6 mm preoperatively and at 6 months, 1 year, 2 years, and 5 years postoperatively with no significant changes (n.s). CONCLUSION: CCP-ACI provided acceptable mid-term outcomes in ODs up to 10-mm in depth without bone grafting despite of no scaffold. The procedure can be one of minimally invasive treatment options for ODs without scaffold-related problems. LEVEL OF EVIDENCE: IV.

Validation of a HPLC method for the quantification and purity determination of SK3530 in drug substance and tablet.

SK3530.2HCl, (2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo[3,2-d]pyrimidin-4-one dihydrochloride), is a novel a new phosphodiesterase type V (PDE V) inhibiting agents. The pharmaceutical development of SK3530 necessitated the availability of an assay for the quantification and purity determination of SK3530 active pharmaceutical ingredient (API) and its pharmaceutical dosage form. A reversed-phase high performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection was developed, consisting of separation on a C18 column with a CapcellPack MG (4.6 mm x 150 mm, 5 microm) column with ammonium acetate buffer (pH 4.0, 20 mM)-acetonitrile (60:40, v/v) as the isocratic mobile phase and UV detection at 250 nm. The method has been shown good chromatographic separation for SK3530 and the other related substances. The method was found to be linear 200-300 microg/ml, precise and accurate. Stress testing showed degradation products, which were well separated from the parent compound, confirming its stability-indication capacity. Moreover, the use of LC-MS and on-line diode array detection enabled us to propose structures for degradation products.