24-month patient-reported outcomes for a novel lumbar total joint replacement.

Background: Lumbar fusion remains a prevalent treatment for degenerative conditions; however, its limitations have sparked interest in alternative motion-sparing procedures. Our study evaluates 24-month postoperative patient-reported outcomes from an OUS pilot clinical study on a novel lumbar total joint replacement (TJR) for degenerative conditions. Methods: Data was collected from 63 patients, of which 56 patients fulfilled the inclusion criteria. Self-reported measures collected for this study are Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), Minimal Symptom State (MSS), Minimal Clinical Important Difference (MCID), Substantial Clinical Benefit (SCB). This retrospective analysis of prospective, IRB-approved collected data reports 24 month patient-reported outcomes on a cohort receiving lumbar TJR. The cohort includes skeletally mature individuals who underwent lumbar TJR at 1-3 Lumbar levels (L1-S1) between 2008 and 2019. Conservative treatment was mandatory for at least 3 months unless facing a neurologic emergency or intractable pain. Descriptive analysis was performed for continuous variables and frequencies were calculated for categorical variables. Results: 63 patients were treated with lumbar TJR and electively participated in data collection after 12 months. 56 patients, with age ranging from 19 to 82 years, and 93 levels were treated with lumbar TJR at 1-3 lumbar levels and had complete follow-up data at 12 and 24 m. No device-related adverse events were reported during the 12-to-24-month follow-up window. At 24 months, patients exhibited sustained clinical improvement in back pain, leg pain, and disability scores, similar to the 12-month observations. An overall improvement in Minimal Clinically Important Difference (MCID) was also noted. Conclusions: Our study shows consistent improvement in PROs, indicating the clinical improvement of lumbar TJR at both the 12-month and 24-month follow-up points, compared to baseline. Acknowledging limitations, including the lack of comparative data with standard of care, these findings suggest that TJR may be a treatment option for indicated lumbar degenerative pathologies.