Re-operation in spinal fusion is high within a 2-year period (~23% Lewin et al., 2021 vs ~1-2% revision rate for hip and knee). There is also a declining success rate with revision surgeries: Daniell and Osti (2008), “No more than 30%, 15% and 5% of patients experience a successful outcome after the second, third and fourth surgeries”.
There is a need to provide more effective options for surgeons so that treatment of revision patients improves.
Recently Patient Specific (PS) spinal fusion implants have been used for patients requiring reoperation. Here we report on how PS implants were used to treat patients in which a variety of primary interventions had failed.
We included lumbar patients requiring a revision of the primary operated level due to device or construct failure, and reoperation of adjacent levels due to either device failure or adjacent segment disease.
Post-operative imaging data (CT) were compared to pre-operative imaging to assess bone remodelling, fusion, subsidence and spinal alignment. Pre-operative and post-operative clinical scores are reported.
Our accrual target was 10 patients. We report clinical results for 11 patients that underwent revision/reoperation with PS lumbar spinal fusion implants for a mean follow up time point of 12.27 months. 5 patients required revision due to failed hardware, and 6 required a reoperation for adjacent segment disease. Mean VAS improved from 8.55 (2.01 Standard Deviation [SD]) pre-operatively to 2.50 (2.87 SD) post-operatively. Mean QoL index scores improved from pre-operative 0.184 (0.284 SD) to 0.683 (0.289 SD) post-operatively.
Radiographic analysis of the revision/reoperation group showed improvement in subchondral bone quality.
PSI offer the unique ability to be tailored to the complex interbody space left after prior devices have failed, meaning that they are a versatile solution to these complex problems. The results of this initial cohort are promising, and we are now looking to increase to a larger sample size.