BACKGROUND: The aim of this study was to determine the clinical and radiological outcomes of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) compared to modified open TLIF via the Wiltse approach for treatment of degenerative diseases of the lumbosacral region. The results were evaluated over a post-operative period of 48 months.
METHODS: Radiological data and medical records of patients who underwent MIS TLIF and modified open TLIF between May 2017 and May 2021 were reviewed. Parameters monitored to evaluate the surgical results were: clinical status, operation time, blood loss, radiation dose to patient, day of discharge, analgesic consumption, fusion, and complications rate. For functional assessment, the Visual Analogue Scale for back pain (VAS-BP), VAS for leg pain (VAS-LP), Oswestry Disability Index (ODI), Patient Satisfaction Rate (PSR), and the complication rate were used.
RESULTS: This study included 57 patients randomly divided into two groups: 30 operated on using the MIS TLIF technique, and 27 operated on using the modified open TLIF technique via the Wiltse approach. 48-month follow-up rates were similar for the two cohorts. Patients did not differ significantly at baseline in terms of ODI, VAS-BP, or VAS-LP. Perioperatively, MIS TLIF was associated with significantly less blood loss (167.3 ± 80.0 vs. 297.9 ± 81.5 ml, p = 1.1E-05), slightly longer procedures (185.7 ± 45.2 vs. 183.1 ± 66.4 minutes, p = 0.76), a lower radiation dose (MIS 16.9 ± 7.1 vs. 22.0 ± 9.7 mGy OPEN p = 0.012), and shorter hospitalisations (MIS 5.9 ± 1.8 vs. 7.7 ± 1.6 days OPEN). The most common complication was radiculitis, which accounted for 33% and 37% in the MIS and the TLIF groups, respectively. The second most common complication was malposition of the fixation material, which accounted for 18.5% in the TLIF group and 20% in the MIS group. The level of fusion achieved was 92.6% in the MIS group versus 92.3% in the TLIF group. There was lower consumption of analgesics in MIS. Patient Satisfaction Rate (PSR) was 90%.
CONCLUSIONS: Clinical and radiological outcomes after MIS TLIF in patients with degenerative disease of the lumbosacral region are generally favourable. MIS TLIF was associated with decreased blood loss perioperatively, a lower radiation dose and an earlier discharge, but there was no difference between MIS TLIF and modified open TLIF in 48-month outcomes in terms of disability, back pain, leg pain, quality of life, or patient satisfaction rate or complication rate. Although the differences taper off over time, MIS TLIF has undeniable advantages in the perioperative and early postoperative periods.

BACKGROUND: Differentiating between degenerative disc disease (DDD), diffuse idiopathic skeletal hyperostosis (DISH), and axial spondyloarthritis (axSpA) represents a diagnostic challenge in patients with low back pain (LBP). We aimed to evaluate the distribution of inflammatory and degenerative imaging features in a real-life cohort of LBP patients referred to a tertiary university rheumatology center.
METHODS: In a retrospective cross-sectional analysis of patients referred for LBP, demographics, symptom information, and available imaging were collected. SpA-like changes were considered in the spine in the presence of one of the following lesions typically related to SpA: erosions, sclerosis, squaring, and syndesmophytes on conventional radiographs (CR) and bone marrow oedema (BMO), erosions, sclerosis, and fat lesions (FL) on MRI. SIJ CR were graded per New York criteria; on MRIs, SIJs were evaluated by quadrant for BMO, erosions, FL, sclerosis and ankylosis, similar to the approach used by the Berlin SIJ MRI scoring system. The final diagnosis made by the rheumatologist was the gold standard. Data were presented descriptively, by patient and by quadrant, and compared among the three diagnosis groups.
RESULTS: Among 136 referred patients, 71 had DDD, 38 DISH, and 27 axSpA; median age 62 years [IQR55-73], 63% males. On CR, SpA-like changes were significantly higher in axSpA in the lumbar (50%, vs. DDD 23%, DISH 22%), in DISH in the thoracic (28%, vs. DDD 8%, axSpA 12%), and in DDD in the cervical spine (67% vs. DISH 0%, axSpA 33%). On MRI, BMO was significantly higher in DISH in the thoracic (37%, vs. DDD 22%, axSpA 5%) and equally distributed in the lumbar spine (35-42%). FL were significantly more frequently identified in DISH and axSpA in the thoracic (56% and 52%) and DDD and axSpA in the lumbar spine (65% and 74%, respectively). Degenerative changes were frequent in the three groups. Sacroiliitis (NY criteria) was identified in 49% (axSpA 76%, DDD 48%, DISH 29%).
CONCLUSIONS: A significant overlap was found among DDD, DISH, and axSpA for inflammatory and degenerative imaging features. Particularly, SpA-like spine CR features were found in one-fourth of patients with DISH, and MRI BMO was found in one-third of those patients.

BACKGROUND: Progenitor cells derived from intervertebral disc tissue demonstrated immunomodulatory and regenerative properties in preclinical studies. We report the safety and efficacy results of a US Food and Drug Administration-approved clinical trial of these cells for the treatment of symptomatic degenerative disc disease.
METHODS: Sixty patients with symptomatic single-level lumbar degenerative disc disease (mean age 37.9 years, 60% men) were enrolled in a randomized, double-blinded, placebo-controlled Phase I/Phase II study at 13 clinical sites. They were randomized to receive single intradiscal injections of either low-dose cells (N = 20), high-dose cells (N = 20), vehicle alone (N = 10), or placebo (N = 10). The primary endpoint was mean visual analog scale (VAS) pain improvement >30% at 52 weeks. Disc volume was radiologically assessed. Adverse events (AEs), regardless of whether they were related to treatment, were reported. Patients were assessed at baseline and at 4, 12, 26, 52, 78, and 104 weeks posttreatment.
RESULTS: At week 52, the high-dose group had a mean VAS percentage decrease from baseline (-62.8%, P = 0.0005), achieving the endpoint of back pain improvement >30%; the mean change was also significantly greater than the minimal clinically important difference of a 20-point decrease (-42.8, P = 0.001). This clinical improvement was maintained at week 104. The vehicle group had a smaller significant decrease in VAS (-52.8%, P = 0.044), while the low-dose and placebo groups showed nonsignificant improvements. Only the high-dose group had a significant change in disc volume, with mean increases of 249.0 mm3 (P = 0.028) at 52 weeks and 402.1 mm3 (P = 0.028) at 104 weeks. A minority of patients (18.3%) reported AEs that were severe. Overall, 6.7% of patients experienced serious AEs, all in the vehicle (n = 1) or placebo (n = 3) groups, none treatment related.
CONCLUSIONS: High-dose allogeneic disc progenitor cells produced statistically significant, clinically meaningful improvements in back pain and disc volume at 1 year following a single intradiscal injection and were safe and well tolerated. These improvements were maintained at 2 years post-injection.
METHODS:
BACKGROUND: NCT03347708-Study to Evaluate the Safety and Preliminary Efficacy of Injectable Disc Cell Therapy, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration.

BACKGROUND: Crossfit athletes consistently recruit or transfer high levels of repetitive forces through the spine, and MRI has documented a higher rate of intervertebral disc degeneration in athletes compared with matched controls. The aim of this study was to evaluate early degenerative spinal disc changes in elite female CrossFit athletes quantified by 3.0 Tesla magnetic resonance imaging (MRI) matched with female none-athletes.
METHODS: In a cross-sectional single-center study 19 asymptomatic adult participants, nine German female elite Crossfit athletes and ten female participants underwent spinal MRI (3.0T). Demographic data, spinal clinical examination results and sport-specific performance parameters were collected prior to the MRI. The primary outcome was the prevalence of degenerative spinal disc changes. The secondary outcome was the grade of degeneration using Pfirrmann grading.
RESULTS: A total of 437 discs underwent spinal MRI (3.0T). The prevalence of early degenerative disc disease was not increased. Pfirrmann degenerative grade did not show significant differences among groups.
CONCLUSIONS: Asymptomatic female elite Crossfit athletes do not show an increased prevalence of degenerative disc disease. Compared to a sex-matched control group, high training volume in Crossfit does not correlate to a higher incidence of degenerative disc changes in young females.

UNASSIGNED: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.
UNASSIGNED: This study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. The safety endpoints were the adverse events and reoperations or revisions at the index level(s).
UNASSIGNED: At 6-month post-op, 76%, 62%-64%, and 64% of patients demonstrated clinical meaningful, and statistically significant improvement in their pain as defined by ZCQ, VAS (back and leg), and ODI, respectively. In addition, 78% of patients noted improvement in PGIC. Two procedure-related adverse events were noted which fully resolved without surgical intervention.
UNASSIGNED: This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties.

This study used the finite element method(FEM) to investigate how pressure on the lumbar spine changes during dynamic movements in different postures: standing, erect sitting on a chair, slumped sitting on a chair, and sitting on the floor. Three load modes (flexion, lateral bending, and axial rotation) were applied to the FEM, simulating movements of the lumbar spine. Results showed no significant difference in pressure distribution on the annulus fiber and nucleus pulposus, representing intradiscal pressure, as well as on the cortical bone during movements between standing and erect sitting postures. However, both slumped sitting on a chair and sitting on the floor postures significantly increased pressure on the nucleus pulposus, annulus fibrosus, and cortical bone in all three movements when compared to standing or erect sitting on a chair. Notably, sitting on the floor resulted in even higher pressure on the nucleus pulposus and annulus fibers compared to slumped sitting on a chair. The decreased lumbar lordosis while sitting on the floor led to the highest increase in pressure on the annulus fiber and nucleus pulposus in the lumbar spine. In conclusion, maintaining an erect sitting position with increased lumbar lordosis during seated activities can effectively reduce intradiscal pressure and cortical bone stress associated with degenerative disc diseases and spinal deformities.

Background Same-level recurrent disc herniation remains a challenge in spine surgery. Although most surgeons agree on discectomy as the treatment of choice for primary lumbar disc herniation, the management of recurrent disc herniation remains ambiguous and largely depends on the operating surgeon. Many surgeons recommend repeat discectomy over fusion because it is cheaper and less invasive. In this study, we analyzed 50 patients who underwent a repeat discectomy. Materials and methods The patients in the study had previously been managed for lumbar disc herniation and then presented with either recurrent same-level herniation or symptoms attributed to the same level. The patients were then managed with a repeat discectomy without fusion. We analyzed the preoperative and postoperative Oswestry Disability Index (ODI), duration of surgery, blood loss, duration of hospitalization, and complications. Results Fifty patients were included: 27 females (54%), and 23 males (46%). They were followed up for an average of 2.81 years (range: 1-4). The mean duration of hospitalization was 4.06 ± 1.5 days (range: 2-8). The operative time was 104.60 minutes (range: 50-195), with an intraoperative blood loss of 85.40 mL (range: 50-150 mL). Durotomy occurred as a complication in eight (16%) patients. The recurrence rate was 26%, with 36% progressing to fusion. The change in preoperative ODI and postoperative ODI was 20.94 ± 7.24 (6-37), with a p-value of 0.04. There were no long-term complications recorded. Conclusion Repeat discectomy is a good management option for same-level recurrent disc herniation. The procedure is associated with low intraoperative blood loss and a short operating time, but there is a significant risk of durotomy. The risk of recurrence remains a concern due to the progression of degenerative changes, especially in the presence of Modic-2 changes. These advantages and disadvantages should be discussed with patients.

With current imaging modalities and diagnostic tests, identifying pain generators in patients with non-specific chronic low back pain (CLBP) is difficult. There is growing evidence of the effectiveness of SPECT/CT examination in diagnosing the source of pain in the spine. The study aims to investigate the effect of posterior interbody fusion on a single-level SPECT/CT positive lumbar degenerative disc disease (DDD).
This is a prospective study of patients with chronic low back pain (CLBP) operated on for a single-level SPECT/CT positive DDD. Primary outcomes were changes in visual analogue scale (VAS) scores and the Oswestry Disability Index (ODI). Secondary outcomes were complications, return to work, satisfaction and willingness to re-undergo surgery.
During a 3-year period, 38 patients underwent single-level fusion surgery. The mean preoperative VAS score of 8.4 (± 1.1) decreased to 3.2 (± 2.5, p < 0.001) and the mean preoperative ODI of 51.5 (± 7.3) improved to 20.7 (± 14.68, p < 0.001) at a 2-year follow-up. A minimum clinically important difference (30% reduction in VAS and ODI) was achieved in 84.2% of patients. Some 71% of patients were satisfied with the surgery results and 89.4% would undergo surgery again. There were four complications, and two patients underwent revision surgery. Some 82.9% of patients returned to work.
Fusion for one-level SPECT/CT positive lumbar DDD resulted in substantial clinical improvement and satisfaction with surgical treatment. Therefore, SPECT/CT imaging could be useful in assessing patients with CLBP, especially those with unclear MRI findings.
ClinicalTrials.gov Identifier: NCT04876586.

Lumbar degenerative disc disease (LDDD) is widely acknowledged as a significant contributor to low back pain (LBP), which is a prevalent and debilitating health condition affecting millions of individuals worldwide. The pathogenesis of LDDD and associated pain mechanisms are thought to be mediated by inflammatory mediators. Autologous conditioned serum (ACS, Orthokine) may be used for symptomatic treatment of LBP due to LDDD. This study aimed to compare the analgesic efficacy and safety of two routes of ACS administration, perineural (periarticular) and epidural (interlaminar), in the conservative treatment of LBP. This study used an open-label, randomized, controlled trial protocol. A group of 100 patients were enrolled in the study and randomly allocated into two comparative groups. Group A (n = 50) received the epidural (interlaminar) approach-2 ultrasound-guided injections as control intervention (each containing two doses of ACS-8 mL). Group B (n = 50) received the perineural (periarticular) approach-2 ultrasound-guided injections as experimental intervention at 7-day intervals (the same volume of ACS). Assessments consisted of an initial assessment (IA) and control assessments at 4 (T1), 12 (T2), and 24 (T3) weeks after the last intervention. Primary outcomes comprised Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Roland Morris Questionnaire (RMQ), and Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Index, Visual Analogue Scale (VAS), and Level Sum Score (LSS). Secondary outcomes included differences between groups in specific endpoints for the above-mentioned questionnaires. In conclusion, this study revealed that both perineural (periarticular) and epidural ACS injections tended to perform in a very similar way. Both routes of Orthokine application show significant improvement in the primary clinical parameters, such as pain and disability, and therefore, both methods can be considered equally effective in managing LBP due to LDDD.

BACKGROUND: Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers.
METHODS: This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery.
RESULTS: A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were \"very satisfied\" at 10 years (98.7% vs 88.9%; P = 0.05).
CONCLUSIONS: In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion.
CONCLUSIONS: The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.
METHODS: