The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study

STUDY DESIGN: Multicenter, international prospective study. OBJECTIVE: This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status. METHODS: As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID. RESULTS: The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29). CONCLUSIONS: The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively

Predicting the Effect of Bilateral Pelvic Osteotomy on Sagittal Alignment Correction and Surrounding Muscles: A Mathematical Model

Study Design. Mathematical Model. Objectives. To investigate the relationship between pelvic osteotomy opening angle (OA) and its effect on spinopelvic sagittal parameters as well as the resting length of surrounding muscles. Methods. Predictive equations correlating OA with spinopelvic parameters were derived using geometric relationships. A geometric model calculated spinopelvic parameters (SVA, pelvic incidence [PI], PT, and T1 pelvic angle [TPA]) produced by progressively increasing the OA. These values were compared to optimal balance criteria in the literature. Four muscles crossing the osteotomy site were evaluated: Gluteus Medius (GMED), Gluteus Maximus (GMAX), Piriformis (P), and Tensor Fascia Lata (TFL). Insertion points were obtained from an OpenSim software model. GMAX and GMED were subdivided into 3 (anterior, middle, and posterior). Results. OA correlated negatively with PI, TPA, and SVA and positively with PT. From baseline SVA of 22 cm, OA 21° reduced SVA to 5cm. OA 23° reduced TPA to 14°. OA 30° increased PT to 20°. OA 26° decreased PI-LL to 10°. OA range of 26°-30° resulted in optimal sagittal deformity correction. OA correlated with SR positively for TFL and anterior GMED and negatively for the rest of muscles. For this OA, the SR approximately decreased 6%, 5%, 6%, 8%, and 5% for posterior GMED, anterior GMAX, middle GMAX, posterior GMAX, and P, respectively. It increased 8% and 4% for anterior GMED and TFL, respectively. Conclusion. Predictive relationships between osteotomy OA and spinopelvic parameters were shown, providing proof of concept that sagittal balance may be achieved via pelvic osteotomy

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion

Background: While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. Methods: A prospective, multicenter, open-label clinical study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT 02969616). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Adverse-event reporting was conducted throughout 12 months of follow-up. Available subject data at 12 months were analyzed. Results: A total of 274 subjects were enrolled into the study, with available data from 201 subjects (73.3%) who completed 12 months of postoperative radiographic and clinical evaluation at the time of analysis. Subjects had a mean age of 60.2 ± 11.5 years. A higher number of women (n = 124, 61.7%) than men (n = 77, 38.3%) were enrolled, with a collective mean BMI of 30.6 + 6.5 kg/m2 (range 18.0–51.4). At month 12, successful fusion was achieved in 90.5% of subjects. A significant (p < 0.001) improvement in ODI, VAS-back, and VAS-leg clinical outcomes was also observed compared to baseline scores. One adverse event related to CBA (postoperative radiculopathy) was reported, with surgical exploration demonstrating interbody extrusion of graft material. This subject reported successful fusion at month 12. Conclusions: CBA represents a viable substitute for harvesting of autograft alone with a high rate of successful fusion and significant improvements in subject-reported outcomes, such as pain and disability. Positive benefit was observed in subjects reporting single and multiple risk factors for pseudoarthrosis

Acetabular Cage Survival and Analysis of Factors Related to Failure

The reported results of acetabular cage reconstruction for pelvic deficiency are widely variable. Our primary question was: what is the survivorship of cage reconstruction with a primary end point of cage revision and secondary end points of radiographic loosening and any reoperation? Secondary questions were: which factors predict cage failure, and what is the functional outcome (SF-36, WOMAC, Harris hip score) of this reconstructive method? We reviewed 72 cage reconstructions in 68 patients. Minimum followup was 1.2 years (mean, 5.1 years; range, 1.2–10.7 years). Five-year cage revision-free survivorship was 87.8%. Five-year loosening-free and acetabular reoperation-free survivorships were 80.7% and 81.3%, respectively. No single preoperative factor (age, gender, severity of pelvic defect, degree of heterotopic ossification, difference in limb lengths and centers of rotation) or intraoperative factor (type of bone graft, type of cage, changes in limb length and center of rotation) predicted cage failure. Functional outcomes were 28.9 (SF-36 Physical Component), 52.4 (SF-36 Mental Component), 33.7 (WOMAC), and 44.2 (Harris). We judged these outcomes acceptable for this sometimes challenging problem. Future techniques for treating pelvic deficiency will need to be compared with these and other outcomes in the literature

Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction

BACKGROUND: Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. OBJECTIVE: To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. METHODS: One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. RESULTS: In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p CONCLUSIONS: In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation