Factors for starting biosimilar TNF inhibitors in patients with rheumatic diseases in the real world.

BACKGROUND: To identify factors for starting biosimilar TNF inhibitors (TNFI) in patients with rheumatic diseases. METHODS AND FINDING: Using a national claims database, we identified patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) who had used TNFIs since they were approved in Korea in 2004. We assessed changes in the proportion of each form of TNFI used between 2004 and 2017. We then selected patients starting on TNFIs between 2013 and 2017 to identify factors for starting biosimilars. In RA (n = 4,216), biosimilars were more likely to be initiated in clinics [odds ratio (OR) 2.54] and in the metropolitan area (OR, 2.02), but were less likely to be initiated in general hospitals (OR 0.40) or orthopedics (OR 0.44). In AS (n = 2,338), biosimilars were common at the hospital level (OR 2.20) and tended to increase over the years (OR 1.16), but were initiated less in orthopedics (OR 0.07). In addition, RA patients were more likely to initiate biosimilars in combination with methotrexate (OR 1.37), but biosimilars were not initiated frequently by patients with higher comorbidity scores (OR 0.97) or receiving glucocorticoids (OR 0.67). The patient factors favoring biosimilar in AS use were not clear. CONCLUSIONS: In Korea, the proportion of biosimilar TNFIs has increased. Type of institution and physician specialty are more important than patient factors in affecting biosimilar use. In RA, biosimilar TNFIs tend to be initiated in combination with MTX, and are less likely to be initiated in patients taking glucocorticoids or in those with high comorbidities.

Is Preexisting Cervical Disk Degeneration a Prognostic Factor in Whiplash-associated Disorders?

STUDY DESIGN: This is a retrospective control study. OBJECTIVE: We aimed to determine whether preexisting cervical disk degeneration is a prognostic factor in Whiplash-associated disorder (WAD). SUMMARY OF BACKGROUND DATA: WAD is a common injury of traffic accident and has a broad range of prognoses. Although numerous studies have investigated prognostic factors in WAD, few have evaluated the effect of preexisting disk degeneration. MATERIALS AND METHODS: This study involved 45 consecutive patients with grade I or II WAD having advanced disk degeneration (at least 1 disk of Miyazaki grade≥III on magnetic resonance imaging) and a control cohort of 52 patients with no or mild disk degeneration (all disks having Miyazaki grades≤II). Clinical assessment included pain severity (assessed by the visual analog scale), neck pain-related disability (assessed by the neck disability index), and physical and mental health condition [assessed by the short-form 36 (SF-36) physical composite score and SF-36 mental composite score, respectively]. Changes in each parameter were evaluated at baseline and at 3-month, 6-month, and 1-year follow-ups and compared between the 2 groups. RESULTS: There were no differences between the 2 groups regarding demographics and baseline outcome parameters (all P>0.05). There were also no differences in improvement in visual analog scale for neck pain, neck disability index, SF-36 physical composite score, or SF-36 mental composite score between the 2 groups (all P>0.05) for each visit. The number of claim closures was significantly lower among patients with advanced degeneration than among controls at 6-month and 1-year follow-ups (P=0.004 and 0.006, respectively). CONCLUSIONS: In the present study, the clinical presentation and prognosis of WAD were not affected by preexisting disk degeneration. However, claim closure was delayed in patients with preexisting disk degeneration. These results suggest that misunderstanding of disk degeneration on magnetic resonance imaging may create persistent illness and lead to continued compensation in WAD.

Is It Beneficial to Remove the Pedicle Screw Instrument After Successful Posterior Fusion of Thoracolumbar Burst Fractures?

STUDY DESIGN: Case-control study. OBJECTIVE: To investigate the clinical and radiological outcomes of pedicle screw removal after successful fusion of thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Implant removal is a common procedure in orthopedic surgery, although the benefits of and indications for removal remain controversial. Previous studies on pedicle screw removal have reported conflicting outcomes, because the study subjects and surgical goals were heterogeneous in nature. METHODS: We studied 45 consecutive patients who underwent implant removal and a control cohort of 45 age- and sex-matched patients who retained their spinal implants after successful posterior fusion of thoracolumbar burst fractures using pedicle screw instrument. In most cases, long-segment instrumentation with short-segment posterior fusion was performed. The mean elapsed period prior to implant removal after index fracture surgery was 18.3 ± 17.6 months. A visual analogue scale for back pain was applied, the Oswestry disability index calculated, and radiological parameters derived at the time of implant removal and 1 and 2 years postoperatively obtained. These data were compared with those of the control group evaluated at the same times after index fracture surgery. RESULTS: Patient demographics, mechanisms of injury, fracture morphologies, and the outcomes of index fracture surgery were similar between the 2 groups. The mean visual analogue scale and Oswestry disability index scores were better at both the 1- and 2-year follow-ups in the implant removal group than in the control group (all P values = 0.000). The segmental motion angle of the implant removal group was 1.6° ± 1.5° at the time of implant removal, and increased significantly to 5.8° ± 3.9° at 1-year follow-up (P = 0.000), and was maintained at this level at the 2-year follow-up (5.9° ± 4.1°) (P = 0.000). CONCLUSION: In patients treated successfully for thoracolumbar burst fractures, pedicle screw removal is beneficial because it alleviates pain and disability. Restoration of the segmental motion angle after implant removal may contribute to the clinical improvement. LEVEL OF EVIDENCE: 3.

Ventral epidural filling technique in interlaminar epidural steroid injection.

STUDY DESIGN: A retrospective case-control study. OBJECTIVE: To evaluate the safety and efficacy of the ventral epidural filling technique in lumbar interlaminar epidural steroid injection (ESI). SUMMARY OF BACKGROUND DATA: The ventral epidural space can be a preferred target in ESI because it contains many spinal pain generators. However, there have been few studies regarding the ventral epidural space filling technique in interlaminar ESI. METHODS: This study involved a retrospective analysis of 150 consecutive patients treated with the ventral epidural filling technique in interlaminar ESI (ventral ESI) and a control cohort of 150 consecutive patients treated with the dorsal epidural filling technique in interlaminar ESI (conventional ESI). The visual analogue scale for leg pain, the visual analogue scale for back pain, and the Oswestry Disability Index were compared at preinjection and 2 weeks, 6 weeks, 6 months, and 1 year postinjection. The groups were compared with regard to repeated injection or surgery within 1 year after the initial procedure. The fluoroscopic time and the procedure-related complications including severe pain (visual analogue scale score>7) during injection, dural puncture (subdural contrast spread), headache, neurological symptoms, and infection were also compared. RESULTS: There were no significant differences in leg pain, back pain, or Oswestry Disability Index improvement at each visit between the ventral ESI group and the conventional ESI group (all P>0.05). The numbers of repeat injections and surgical procedures were not significantly different between 2 groups (P=0.262 and 0.385, respectively). There were no significant differences in severe pain at injection (P=0.326), dural puncture (P=0.428), headache (P=0.393), neurological symptom (P=0.419), or infection (P=0.500) between the 2 groups. The fluoroscopic time was significantly shorter in ventral than in conventional ESI (P<0.000). CONCLUSION: The ventral epidural filling technique can be performed safely and more easily during lumbar interlaminar ESI. The clinical results and procedure-related complications with this technique were comparable with those seen with conventional interlaminar ESI. LEVEL OF EVIDENCE: 3.

Factors affecting postural reduction in posterior surgery for thoracolumbar burst fracture.

STUDY DESIGN: Retrospective analysis of a prospectively collected patient database. OBJECTIVE: To investigate the significance and relevant factors of postural kyphosis reduction during posterior surgical treatment of thoracolumbar burst fracture. SUMMARY OF BACKGROUND DATA: Optimal reduction of kyphosis is a goal in the surgical treatment of thoracolumbar burst fracture. Several factors are known to limit the amount of posterior surgical reduction. However, few comprehensive assessments of intraoperative postural reduction have been reported. METHODS: Seventy-two consecutive patients who underwent posterior surgical treatment for thoracolumbar (T11-L2) burst fracture were included. Postural reduction was evaluated using C-arm fluoroscopic images and regarded as insufficient when the lateral Cobb angle was ≥20 degrees or AP Cobb angle ≥10 degrees. Clinical characteristics including sex, age, body mass index, time to operation, injury level, and neurological injury, as well as radiologic characteristics including fracture morphology, fracture deformity, canal stenosis, and ligament injuries were investigated to determine the relevant factors. RESULTS: The mean lateral Cobb angle was 22.2±11.0 degrees preoperatively, 16.4±7.7 degrees after postural reduction (P<0.001), and 13.4±6.9 degrees after instrumental reduction (P<0.001). Insufficient postural reduction was found in 25 (34.7%) patients, all of which were lateral. The relevant factors for insufficient reduction, as identified by multivariate analysis, were time to operation >72 hours (OR, 6.453; 95% CI, 1.283-32.553), burst-split type injury (OR, 4.689; 95% CI, 1.314-25.225), and anterior compression ratio >0.5 (OR, 2.284; 95% CI, 1.151-19.811). CONCLUSIONS: Postural reduction plays an important role in the reduction of kyphosis and compression deformity after thoracolumbar burst fracture. However, it was affected by delayed operation time, burst-split type injury, and severe anterior vertebral compression.

An unusual case of postaxial polydactyly of the foot treated by metatarsal transfer.

Postaxial polydactyly is a relatively rare congenital deformity. We present a unique unusual fourth metatarsal type polydactyly in which the extra bone from the fourth metatarsal bone articulated with the most lateral ray proximal phalanx. We discuss the surgical management of this problem using a bone transfer from the extra metatarsal bone within the midfoot. This is the first reported case of fourth metatarsal-type polydactyly treated by bone transfer of the extra metatarsal bone and internal plate fixation to recover normal articulation. The normal orientation of the metatarsophalangeal joint, alignment, and cosmesis are important determinants when selecting the bone to be excised in cases of lateral ray foot polydactyly.

Effect of different bone marrow stimulation techniques (BSTs) on MSCs mobilization.

The therapeutic effect of bone marrow stimulation techniques (BSTs) is mainly attributed to the role of mesenchymal stem cells (MSCs) from the bone marrow. However, no studies have directly shown the amount of MSCs drained by BSTs. This study hypothesized that differences in the opening of subchondral bone affect the number of MSCs drained from the bone marrow. We purposed that as the exposed area and hole size of BSTs vary, the number of MSCs drained out was measured. Three groups of different BSTs were designed that have variations in the sizes of total exposed area and individual holes. Three different BSTs using a curette, 1.5- and 0.8-mm awls were carried out on the full-thickness femoral cartilage defect of young rabbits. After BST, the number of MSCs in the blood clot was measured by CFU-Fs assay. As the size of the total exposed area increased, so did the number of MSCs obtained. The number of MSCs drained from bone marrow may vary depending on different BSTs and this could affect therapeutic efficacy of cartilage defect. As current microfracture (MF) method cannot drain the most MSCs clinically, more improved surgery technique is needed.

Intraneural ganglion in the digital nerve of the thumb: a case report.

Intraneural ganglion cysts of the peripheral nerve in the upper extremity are uncommon and usually originate within the epineurium of the peripheral nerve. The current report discusses a 57-year-old woman with a neuropathic nodular mass on the thenar area of the left hand. Magnetic resonance images showed a lobulated, homogeneous mass of high signal intensity on T2-weighted images and low signal intensity with peripheral enhancement on T1-weighted images. Excisional biopsy and histopathologic examination confirmed an intraneural ganglion cyst of the digital nerve of the thumb. A successful result was obtained by surgical treatment, and there was no recurrence of abnormal sensation and paraesthesia during the 3-year follow-up period.

Evaluation of transtibial double-bundle posterior cruciate ligament reconstruction using a single-sling method with a tibialis anterior allograft.

BACKGROUND: The authors devised a double-bundle posterior cruciate ligament reconstruction technique in combination with a single-sling method. However, the double-bundle technique needs more simplicity and a decreased possibility of failure. HYPOTHESIS: A novel surgical technique of transtibial double-bundle posterior cruciate ligament reconstruction using a single-sling method with a tibialis anterior allograft, previously introduced, produces satisfactory results. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Twenty-one patients who underwent double-bundle transtibial isolated posterior cruciate ligament reconstruction using a single-sling method between July 2003 and September 2007 were enrolled in this study. The exclusion criteria applied were (1) a multiligamentous injury, (2) posterior cruciate ligament reconstruction previously performed using another technique, and (3) the presence of any additional injury capable of affecting knee stability. The Lysholm and International Knee Documentation Committee (IKDC) knee scales were used for the clinical outcome evaluation. Stability was evaluated using a KT-2000 arthrometer. The evaluation was performed by comparing preoperative and last follow-up results. RESULTS: Nineteen men and 2 women were enrolled, with a mean follow-up of 49.2 months (range, 25-73 months). The mean Lysholm score was 53 ± 5.3 (range, 34-68) preoperatively and improved to 83.5 ± 13 (range, 61-97) at the last follow-up after surgery (P < .001). The IKDC score also improved from preoperative (0 A, 0 B, 7 C, 14 D) to final follow-up (8 A, 9 B, 3 C, 1 D; P < .001). Mean side-to-side difference in posterior translation, measured using the KT-2000 arthrometer, was 13.5 ± 1.2 mm preoperatively and 3.4 ± 0.8 mm at last follow-up evaluations (mean 51.7 months postoperatively). CONCLUSION: After follow-up for longer than 24 months, the transtibial double-bundle posterior cruciate ligament reconstruction with a single sling was found to produce satisfactory clinical and stability results, which indicates that the described technique should be viewed as a viable alternative.