Cellular Bone Matrix in Spine Surgery - Are They Worth the Risk: A Systematic Review.

STUDY DESIGN: Systematic Review. OBJECTIVE: To review the literature for complications and outcomes after the implantation of cellular bone matrix (CBM) during spine fusion. METHODS: The PubMed database was queried from inception to January 31, 2023 for any articles that discussed the role of and identified a specific CBM in spinal fusion procedures. Adverse events, reoperations, methods, and fusion rates were collected from all studies and reported. RESULTS: Six hundred articles were identified, of which 19 were included that reported outcomes of 7 different CBM products. Seven studies evaluated lumbar fusion, 11 evaluated cervical fusion, and 1 study reported adverse events of a single CBM product. Only 4 studies were comparative studies while others were limited to case series. Fusion rates ranged from 68% to 98.7% in the lumbar spine and 87% to 100% in the cervical spine, although criteria for radiographic fusion was variable. While 7 studies reported no adverse events, there was no strict consensus on what constituted a complication. One study reported catastrophic disseminated tuberculosis from donor contaminated CBM. The authors of 14 studies had conflicts of interest with either the manufacturer or distributor for their analyzed CBM. CONCLUSIONS: Current evidence regarding the use of cellular bone matrix as an osteobiologic during spine surgery is weak and limited to low-grade non-comparative studies subject to industry funding. While reported fusion rates are high, the risk of severe complications should not be overlooked. Further large clinical trials are required to elucidate whether the CBMs offer any benefits that outweigh the risks.

Modic Changes of the Cervical and Lumbar Spine and Their Effect on Neck and Back Pain: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic Review. OBJECTIVES: To systematically review the current literature and perform a meta-analysis on patients with cervical or lumbar spine Modic changes to determine if their baseline axial back pain and disability are comparable to patients without Modic changes. METHODS: A systematic review of the PubMed database was conducted in accordance with PRISMA guidelines. A meta-analysis was performed to compare the mean differences in back pain, leg pain, and disability based on the presence of cervical or lumbar spine Modic changes. A subgroup analysis of the different types of Modic changes was conducted to determine if Modic type affected back pain or disability. RESULTS: - After review of 259 articles, 17 studies were included for meta-analysis and ten studies were included for qualitative synthesis. In the lumbar spine, 10 high-quality studies analyzed Visual Analog Scale (VAS) back pain, 10 evaluated VAS leg pain, and 8 analyzed Oswestry Disability Index. VAS back pain (mean difference (MD), -.38; 95% CI, -.61 - .16) and Oswestry disability index (MD -2.52; 95% CI, -3.93 - -1.12) were significantly lower in patients without Modic changes. Modic change subtype was not associated with differences in patient-reported outcomes. Patients with cervical spine Modic changes did not experience more severe pain than those without MC. CONCLUSIONS: Modic changes in the lumbar spine are not associated with clinically significant axial low back pain severity or patient disability. Similar to the lumbar spine, Modic changes in the cervical spine are not associated with symptom severity, but they are associated with pain duration.

Evaluating Nonoperative Treatment for Low Back Pain in the Presence of Modic Changes: A Systematic Review.

OBJECTIVE: The objective of this study was to summarize and assess the current literature evaluating nonoperative treatments for patients with Modic changes (MCs) and low back pain (LBP). METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The PubMed database was searched from its inception until May 1, 2022 for studies evaluating MC and clinical outcomes. Key findings, treatment details, and patient information were extracted from included studies. Study quality was assessed using the Newcastle-Ottawa Scale. RESULTS: Eighteen studies were included in this review, encompassing a total of 2452 patients, 1713 of whom displayed baseline MC. Seventy-eight percent of studies were high quality. Of included studies, 2 evaluated antibiotics, 5 evaluated steroid injections, 6 evaluated conservative therapies, and 5 evaluated other treatment modalities. Antibiotics and bisphosphonates improved treatment in patients with MC. Patients with MC without disc herniation benefited from conservative therapy, while those with Type I Modic changes and disc herniation experienced poorer improvement. Significant variability exists in reported outcomes following steroid injections. CONCLUSIONS: Nonoperative therapy may provide patients with MC with significant benefits. Patients may benefit from therapies not traditionally utilized for LBP such as antibiotics or bisphosphonates, but conservative therapy is not recommended for patients with concomitant MC and disc herniation. The large variation in follow-up times and outcome measures contributes to significant heterogeneity in studies and inability to predict long-term patient outcomes. More long-term studies are needed to assess nonoperative treatments for LBP in patients with MC.

Evaluating the Impact of Modic Changes on Operative Treatment in the Cervical and Lumbar Spine: A Systematic Review and Meta-Analysis.

Modic changes (MCs) are believed to be potential pain generators in the lumbar and cervical spine, but it is currently unclear if their presence affects postsurgical outcomes. We performed a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All studies evaluating cervical or lumbar spine postsurgical outcomes in patients with documented preoperative MCs were included. A total of 29 studies and 6013 patients with 2688 of those patients having preoperative MCs were included. Eight included studies evaluated cervical spine surgery, eleven evaluated lumbar discectomies, nine studied lumbar fusion surgery, and three assessed lumbar disc replacements. The presence of cervical MCs did not impact the clinical outcomes in the cervical spine procedures. Moreover, most studies found that MCs did not significantly impact the clinical outcomes following lumbar fusion, lumbar discectomy, or lumbar disc replacement. A meta-analysis of the relevant data found no significant association between MCs and VAS back pain or ODI following lumbar discectomy. Similarly, there was no association between MCs and JOA or neck pain following ACDF procedures. Patients with MC experienced statistically significant improvements following lumbar or cervical spine surgery. The postoperative improvements were similar to patients without MCs in the cervical and lumbar spine.