Abstract
BACKGROUND: Spinal rods used for adult spinal deformity (ASD) correction are usually manufactured straight and bent manually during surgery. Pre-bent patient-specific spinal rods (PSSR) developed with software provide the surgeon with an intraoperative deformity correction consistent with the surgical plan. Our aim was to report clinical and radiological outcomes using PSSR. We investigated rates of junctional complications both proximally [kyphosis (PJK) and failure (PJF)] and distally [failure (DJF)]. METHODS: Prospective case series of 20 consecutive patients who underwent ≥4 level ASD surgery with PSSR at a single institution between January 2019 and December 2022. Preoperative, 6-week, 6-month, 12-month, 24-month, and final follow-ups assessed patient satisfaction (Ottawa decision regret questionnaire) and patient reported outcome measures (PROMs) [visual analogue scale (VAS; Back/Leg), Oswestry disability index (ODI), and 12-Item Short Form Survey (SF-12)]. Sagittal spinopelvic parameters [sagittal vertical axis (SVA), pelvic tilt (PT), and pelvic incidence and lumbar lordosis mismatch (PI-LL)] measured by serial EOS scans were performed preoperatively then compared to planned correction and postoperative measures. Interoperative cages (narrow/wide) were placed for interbody support. PJK risk score assessed likelihood of developing kyphosis. Serial computed tomography (CT) imaging assessed complication (fusion/subsidence). RESULTS: The mean age of the patients (75% female) was 71.9±6.9 years, and the mean follow-up was 25.2±8.6 [7-40] months. Preoperative mean PROMs showed statistically significant overall improvement (P<0.001) postoperatively to final follow-up. Four patients without wide footprint cages at L4/5 or L5/S1, suffered DJF and reported regret undergoing surgery. Statistically significant difference (P<0.001) between preoperative and surgical plan in SVA and PI-LL but not in PT (P=0.058). No statistically significant difference in surgical plan versus the postoperative SVA, PI-LL, and PT (due to difficulty achieving the surgical plan, and also to maintaining the correction). One patient suffered PJF. There was a mean proximal kyphotic angle (PKA) of 17.8±13.0 degrees and PJK risk score of 3.7±1.0 with 40% who experienced PJK. No rod breakages were observed. CONCLUSIONS: In this series, PSSR improved PROMs and treated ASD. Sagittal parameters planned preoperatively correlated with postoperative correction. PJF was reduced, compared to the literature (35%), but PJK was observed over time. DJF occurred and was related to the absence of interbody cages at the lumbosacral junction and decisional regret.