Long-Term Effect of SpineJack in the Treatment of Traumatic and Osteoporotic Vertebral Fractures

Background: SpineJack is an expandable intravertebral implant used for vertebral augmentation in traumatic and osteoporotic vertebral fractures. This systematic review evaluated its long-term radiological durability, clinical outcomes, subsequent vertebral fractures, complications, and reinterventions beyond 24 months. Methods: PubMed/MEDLINE, Embase, Scopus, and the Cochrane Library were searched from inception to 16 September 2026. Studies including adults treated with SpineJack were eligible when at least one relevant outcome was reported at ≥24 months or mean/median follow-up was ≥24 months. Risk of bias was assessed using RoB 2, ROBINS-I, or JBI tools and certainty of evidence using GRADE. Quantitative pooling was restricted to clinically compatible outcomes. Results: Nine studies met the eligibility criteria. Single-study randomized evidence suggested more favorable long-term vertebral correction with SpineJack than balloon kyphoplasty in osteoporotic fractures (MD −5.39°, 95% CI −8.53 to −2.25) and nonsurgical management in traumatic fractures (MD −7.50°, 95% CI −9.86 to −5.14). However, maintenance of vertebral height or kyphotic correction did not consistently translate into superior clinical outcomes. In the SPICO trial, SpineJack produced more favorable radiological alignment at 24 months, whereas VAS, ODI, and EQ-5D outcomes were similar to nonsurgical management. An exploratory synthesis of three osteoporotic studies yielded an adjacent-fracture proportion of 13.8% (Hartung–Knapp 95% CI 1.7–59.0%; I2 = 87.9%), with substantial heterogeneity and imprecision. Cement leakage, cement displacement, subsequent fractures, and occasional reinterventions were reported, while clinically significant late treated-level failure appeared uncommon but was inconsistently defined. Certainty of evidence was low to very low for most long-term outcomes. Conclusions: Available evidence suggests that local vertebral correction after SpineJack may remain substantially preserved beyond 2 years in selected patients, but radiological durability should not be interpreted as established long-term clinical superiority. Vertebral augmentation should be regarded as one component of a broader treatment strategy that includes identification and treatment of osteoporosis, secondary fracture prevention, assessment of modifiable fall risk, and appropriate rehabilitation. Larger standardized comparative studies are required to define long-term patient-centered benefit and device-related risk. At the same time, maintenance of vertebral height or kyphotic correction does not reliably translate into superior long-term pain, disability, or health-related quality-of-life outcomes.