Study Design. Prospective, observational multicenter clinical study. Objective. Evaluated cervical spine fusion using a 5-factor scale following multi-level ACDF. Secondary assessments included patient-reported outcome measures for pain and function and complications. Summary of Background Data. Multi-level cervical degenerative spine disease causes pain, instability, and neurological impairment often requiring ACDF. Autologous bone poses harvesting challenges requiring consideration of alternatives such as allogenic and synthetic grafts. ViviGen® cellular bone matrix, containing osteoblasts, osteocytes and bone lining cells, exhibits osteogenic potential making it an option for bone fusion. Evaluating bone fusion from imaging remains a challenge, with no scientific consensus on assessment criteria. Methods. 95 patients with 2- or 3-level ACDF enrolled between July 2016 and July 2018 in a multi-center, prospective study. Follow-up occurred at 6 weeks as well as 3, 6, 12, and optionally at 24 months. Standard ACDF approach was followed with interbody allograft spacer supplemented with ViviGen® cellular bone matrix and cervical plating. Statistical analysis included chi-square, t-test, and ANOVA tests. Results. 5-factor successful fusion rates ranged from 63.8% to 77.6% for the C3-C4 to C6-C7 levels (73.0% overall). Single factor-based successful fusion ranged from 72.4% to 99.5% with bridging bone endplate to endplate present at 80.1% of levels at last follow-up based on independent assessment. CT analysis of a subset of patients identified 96% of levels fused. NDI, SF12 PCS, and VAS scores all improved significantly ( P <0.05) during the follow-up period. Complications were limited and manageable. Only translational motion ≤1.25 mm correlated positively with a clinical outcome (SF12-PCS) on univariate analysis. Conclusion. This study demonstrated favorable fusion outcomes after 2- or 3-level ACDF procedures using a lineage-committed cellular matrix using a rigorous 5-factor scale. Postoperative patient-reported outcomes showed significant improvement in pain and function. Consensus for fusion criteria assessing true bone graft efficacy is needed.
Study Design. Retrospective cohort study Objective. This study aimed to evaluate the prevalence of patient-reported bladder dysfunction in individuals with degenerative cervical myelopathy (DCM), its impact on quality of life (QOL), and postoperative bladder function and QOL improvements. Summary of Background Data. DCM frequently causes bladder dysfunction, in addition to limb neurological deficits, which substantially impair QOL. Although it is well established that posterior decompression surgery improves neurological function, its effect on patient-reported bladder function remains unclear. Methods. We retrospectively analyzed prospectively collected data from 163 patients who underwent cervical laminoplasty for DCM during 2019–2021. Bladder dysfunction and QOL were assessed using the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), particularly its bladder dysfunction (CMEQ-BD) and QOL (CMEQ-QOL) domains. Patients with a preoperative CMEQ-BD score of <90 were considered to have bladder dysfunction. Postoperative improvement was defined as a >20-point increase or 2-year postoperative CMEQ-BD score of ≥90. Results. Preoperative patient-reported bladder dysfunction was identified in 123 of the 163 patients. Compared with patients without bladder dysfunction, those with bladder dysfunction were significantly older and had worse QOL. Multivariate analysis showed that bladder dysfunction was independently associated with lower preoperative QOL (β=−0.167, P =0.031). At postoperative 2 years, only 27 of the 123 patients (22.0%) experienced postoperative bladder function improvement. No demographic or clinical factors were significantly associated with postoperative bladder function recovery. However, patients with improved bladder function showed significantly greater improvements in neurological function (JOA score, P =0.007) and QOL ( P <0.001) than those without improvement. Conclusions. Patient-reported bladder dysfunction was highly prevalent in patients with DCM and was independently associated with impaired QOL. However, bladder dysfunction rarely improved postoperatively. These findings suggest that considering bladder dysfunction may be helpful when determining the optimal surgery timing in patients with DCM. Level of Evidence. Level Ⅲ
