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Ian McCarthy, Michael O'Brien, Christopher Ames, Chessie Robinson, Thomas Errico, David W. Polly Jr. and Richard Hostin

Object

Incremental cost-effectiveness analysis is critical to the efficient allocation of health care resources; however, the incremental cost-effectiveness ratio (ICER) of surgical versus nonsurgical treatment for adult spinal deformity (ASD) has eluded the literature, due in part to inherent empirical difficulties when comparing surgical and nonsurgical patients. Using observed preoperative health-related quality of life (HRQOL) for patients who later underwent surgery, this study builds a statistical model to predict hypothetical quality-adjusted life years (QALYs) without surgical treatment. The analysis compares predicted QALYs to observed postoperative QALYs and forms the resulting ICER.

Methods

This was a single-center (Baylor Scoliosis Center) retrospective analysis of consecutive patients undergoing primary surgery for ASD. Total costs (expressed in 2010 dollars) incurred by the hospital for each episode of surgical care were collected from administrative data and QALYs were calculated from the 6-dimensional Short-Form Health Survey, each discounted at 3.5% per year. Regression analysis was used to predict hypothetical QALYs without surgery based on preoperative longitudinal data for 124 crossover surgical patients with similar diagnoses, baseline HRQOL, age, and sex compared with the surgical cohort. Results were projected through 10-year follow-up, and the cost-effectiveness acceptability curve (CEAC) was estimated using nonparametric bootstrap methods.

Results

Three-year follow-up was available for 120 (66%) of 181 eligible patients, who were predominantly female (89%) with average age of 50. With discounting, total costs averaged $125,407, including readmissions, with average QALYs of 1.93 at 3-year follow-up. Average QALYs without surgery were predicted to be 1.6 after 3 years. At 3- and 5-year follow-up, the ICER was $375,000 and $198,000, respectively. Projecting through 10-year follow-up, the ICER was $80,000. The 10-year CEAC revealed a 40% probability that the ICER was $80,000 or less, a 90% probability that the ICER was $90,000 or less, and a 100% probability that the ICER was less than $100,000.

Conclusions

Based on the WHO's suggested upper threshold for cost-effectiveness (3 times per capita GDP, or $140,000 in 2010 dollars), the analysis reveals that surgical treatment for ASD is cost-effective after a 10-year period based on predicted deterioration in HRQOL without surgery. The ICER well exceeds the WHO threshold at earlier follow-up intervals, highlighting the importance of the durability of surgical treatment in assessing the value of surgical intervention. Due to the study's methodology, the results are dependent on the predicted deterioration in HRQOL without surgery. As such, the results may not extend to patients whose HRQOL would remain steady without surgery. Future research should therefore pursue a direct comparison of QALYs for surgical and nonsurgical patients to better understand the cost-effectiveness of surgery for the average ASD patient.

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Kseniya Slobodyanyuk, Caroline E. Poorman, Justin S. Smith, Themistocles S. Protopsaltis, Richard Hostin, Shay Bess, Gregory M. Mundis Jr., Frank J. Schwab and Virginie Lafage

Object

The goal of this study was to determine the outcome and risk factors in patients with adult spinal deformity (ASD) who elected to receive nonoperative care.

Methods

In this retrospective study the authors reviewed a nonoperative branch of the International Spine Study Group database, derived from 10 sites across the US. Specific inclusion criteria included nonoperative treatment for ASD and the availability of Scoliosis Research Society (SRS)-22 scores and radiographic data at baseline (BL) and at 1-year (1Y) follow-up. Health-related quality of life measures were assessed using the SRS-22 and radiographic data. Changes in SRS-22 scores were evaluated by domain and expressed in number of minimum clinically important differences (MCIDs) gained or lost; BL and 1Y scores were also compared with age- and sex-matched normative references.

Results

One hundred eighty-nine patients (mean age 53 years, 86% female) met inclusion criteria. Pain was the domain with the largest offset for 43% of patients, followed by the Appearance (23%), Activity (18%), and Mental (15%) domains. On average, patients improved 0.3 MCID in Pain over 1Y, without changes in Activity or Appearance. Baseline scores significantly impacted 1Y outcomes, with up to 85% of patients in the mildest category of deformity being classified as < 1 MCID of normative reference at 1Y, versus 0% of patients with the most severe initial deformity. Baseline radiographic parameters did not correlate with outcome.

Conclusions

Patients who received nonoperative care are significantly more disabled than age- and sex-matched normative references. The likelihood for a patient to reach SRS scores similar to the normative reference at 1Y decreases with increased BL disability. Nonoperative treatment is a viable option for certain patients with ASD, and up to 24% of patients demonstrated significant improvement over 1Y with nonoperative care.

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Frank J. Schwab, Ashish Patel, Christopher I. Shaffrey, Justin S. Smith, Jean-Pierre Farcy, Oheneba Boachie-Adjei, Richard A. Hostin, Robert A. Hart, Behrooz A. Akbarnia, Douglas C. Burton, Shay Bess and Virginie Lafage

Object

Pedicle subtraction osteotomy (PSO) is a surgical procedure that is frequently performed on patients with sagittal spinopelvic malalignment. Although it allows for substantial spinopelvic realignment, suboptimal realignment outcomes have been reported in up to 33% of patients. The authors' objective in the present study was to identify differences in radiographic profiles and surgical procedures between patients achieving successful versus failed spinopelvic realignment following PSO.

Methods

This study is a multicenter retrospective consecutive PSO case series. The authors evaluated 99 cases involving patients who underwent PSO for sagittal spinopelvic malalignment. Because precise cutoffs of acceptable residual postoperative sagittal vertical axis (SVA) values have not been well defined, comparisons were focused between patient groups with a postoperative SVA that could be clearly considered either a success or a failure. Only cases in which the patients had a postoperative SVA of less than 50 mm (successful PSO realignment) or more than 100 mm (failed PSO realignment) were included in the analysis. Radiographic measures and PSO parameters were compared between successful and failed PSO realignments.

Results

Seventy-nine patients met the inclusion criteria. Successful realignment was achieved in 61 patients (77%), while realignment failed in 18 (23%). Patients with failed realignment had larger preoperative SVA (mean 217.9 vs 106.7 mm, p < 0.01), larger pelvic tilt (mean 36.9° vs 30.7°, p < 0.01), larger pelvic incidence (mean 64.2° vs 53.7°, p < 0.01), and greater lumbar lordosis–pelvic incidence mismatch (−47.1° vs −30.9°, p < 0.01) compared with those in whom realignment was successful. Failed and successful realignments were similar regarding the vertebral level of the PSO, the median size of wedge resection 22.0° (interquartile range 16.5°−28.5°), and the numerical changes in pre- and postoperative spinopelvic parameters (p > 0.05).

Conclusions

Patients with failed PSO realignments had significantly larger preoperative spinopelvic deformity than patients in whom realignment was successful. Despite their apparent need for greater correction, the patients in the failed realignment group only received the same amount of correction as those in the successfully realigned patients. A single-level standard PSO may not achieve optimal outcome in patients with high preoperative spinopelvic sagittal malalignment. Patients with large spinopelvic deformities should receive larger osteotomies or additional corrective procedures beyond PSOs to avoid undercorrection.

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Virginie Lafage, Frank Schwab, Shaleen Vira, Robert Hart, Douglas Burton, Justin S. Smith, Oheneba Boachie-Adjei, Alexis Shelokov, Richard Hostin, Christopher I. Shaffrey, Munish Gupta, Behrooz A. Akbarnia, Shay Bess and Jean-Pierre Farcy

Object

Pedicle subtraction osteotomy (PSO) is a spinal realignment technique that may be used to correct sagittal spinal imbalance. Theoretically, the level and degree of resection via a PSO should impact the degree of sagittal plane correction in the setting of deformity. However, the quantitative effect of PSO level and focal angular change on postoperative spinopelvic parameters has not been well described. The purpose of this study is to analyze the relationship between the level/degree of PSO and changes in global sagittal balance and spinopelvic parameters.

Methods

In this multicenter retrospective study, 70 patients (54 women and 16 men) underwent lumbar PSO surgery for spinal imbalance. Preoperative and postoperative free-standing sagittal radiographs were obtained and analyzed by regional curves (lumbar, thoracic, and thoracolumbar), pelvic parameters (pelvic incidence and pelvic tilt [PT]) and global balance (sagittal vertical axis [SVA] and T-1 spinopelvic inclination). Correlations between PSO parameters (level and degree of change in angle between the 2 adjacent vertebrae) and spinopelvic measurements were analyzed.

Results

Pedicle subtraction osteotomy distribution by level and degree of correction was as follows: L-1 (6 patients, 24°), L-2 (15 patients, 24°), L-3 (29 patients, 25°), and L-4 (20 patients, 22°). There was no significant difference in the focal correction achieved by PSO by level. All patients demonstrated changes in preoperative to postoperative parameters including increased lumbar lordosis (from 20° to 49°, p < 0.001), increased thoracic kyphosis (from 30° to 38°, p < 0.001), decreased SVA and T-1 spinopelvic inclination (from 122 to 34 mm, p < 0.001 and from +3° to −4°, p < 0.001, respectively), and decreased PT (from 31° to 23°, p < 0.001). More caudal PSO was correlated with greater PT reduction (r = −0.410, p < 0.05). No correlation was found between SVA correction and PSO location. The PSO degree was correlated with change in thoracic kyphosis (r = −0.474, p < 0.001), lumbar lordosis (r = 0.667, p < 0.001), sacral slope (r = 0.426, p < 0.001), and PT (r = −0.358, p < 0.005).

Conclusions

The degree of PSO resection correlates more with spinopelvic parameters (lumbar lordosis, thoracic kyphosis, PT, and sacral slope) than PSO level. More importantly, PSO level impacts postoperative PT correction but not SVA.

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Virginie Lafage, Neil J. Bharucha, Frank Schwab, Robert A. Hart, Douglas Burton, Oheneba Boachie-Adjei, Justin S. Smith, Richard Hostin, Christopher Shaffrey, Munish Gupta, Behrooz A. Akbarnia and Shay Bess

Object

Sagittal spinopelvic imbalance is a major contributor to pain and disability for patients with adult spinal deformity (ASD). Preoperative planning is essential for pedicle subtraction osteotomy (PSO) candidates; however, current methods are often inaccurate because no formula to date predicts both postoperative sagittal balance and pelvic alignment. The authors of this study aimed to evaluate the accuracy of 2 novel formulas in predicting postoperative spinopelvic alignment after PSO.

Methods

This study is a multicenter retrospective consecutive PSO case series. Adults with spinal deformity (> 21 years old) who were treated with a single-level lumbar PSO for sagittal imbalance were evaluated. All patients underwent preoperative and a minimum of 6-month postoperative radiography. Two novel formulas were used to predict the postoperative spinopelvic alignment. The results predicted by the formulas were then compared with the actual postoperative radiographic values, and the formulas' ability to identify successful (sagittal vertical axis [SVA] ≤ 50 mm and pelvic tilt [PT] ≤ 25°) and unsuccessful (SVA > 50 mm or PT > 25°) outcomes was evaluated.

Results

Ninety-nine patients met inclusion criteria. The median absolute error between the predicted and actual PT was 4.1° (interquartile range 2.0°–6.4°). The median absolute error between the predicted and actual SVA was 27 mm (interquartile range 11–47 mm). Forty-one of 54 patients with a formula that predicted a successful outcome had a successful outcome as shown by radiography (positive predictive value = 0.76). Forty-four of 45 patients with a formula that predicted an unsuccessful outcome had an unsuccessful outcome as shown by radiography (negative predictive value = 0.98).

Conclusions

The spinopelvic alignment formulas were accurate when predicting unsuccessful outcomes but less reliable when predicting successful outcomes. The preoperative surgical plan should be altered if an unsuccessful result is predicted. However, even after obtaining a predicted successful outcome, surgeons should ensure that the predicted values are not too close to unsuccessful values and should identify other variables that may affect alignment. In the near future, it is anticipated that the use of these formulas will lead to better surgical planning and improved outcomes for patients with complex ASD.

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Taemin Oh, Justin K. Scheer, Robert Eastlack, Justin S. Smith, Virginie Lafage, Themistocles S. Protopsaltis, Eric Klineberg, Peter G. Passias, Vedat Deviren, Richard Hostin, Munish Gupta, Shay Bess, Frank Schwab, Christopher I. Shaffrey and Christopher P. Ames

OBJECT

Alignment changes in the cervical spine that occur following surgical correction for thoracic deformity remain poorly understood. The purpose of this study was to evaluate such changes in a cohort of adults with thoracic deformity treated surgically.

METHODS

The authors conducted a multicenter retrospective analysis of consecutive patients with thoracic deformity. Inclusion criteria for this study were as follows: corrective osteotomy for thoracic deformity, upper-most instrumented vertebra (UIV) between T-1 and T-4, lower-most instrumented vertebra (LIV) at or above L-5 (LIV ≥ L-5) or at the ilium (LIV-ilium), and a minimum radiographic follow-up of 2 years. Sagittal radiographic parameters were assessed preoperatively as well as at 3 months and 2 years postoperatively, including the C-7 sagittal vertical axis (SVA), C2–7 cervical lordosis (CL), C2–7 SVA, T-1 slope (T1S), T1S minus CL (T1S-CL), T2–12 thoracic kyphosis (TK), apical TK, lumbar lordosis (LL), pelvic incidence (PI), PI-LL, pelvic tilt (PT), and sacral slope (SS).

RESULTS

Fifty-seven patients with a mean age of 49.1 ± 14.6 years met the study inclusion criteria. The preoperative prevalence of increased CL (CL > 15°) was 48.9%. Both 3-month and 2-year apical TK improved from baseline (p < 0.05, statistically significant). At the 2-year follow-up, only the C2–7 SVA increased significantly from baseline (p = 0.01), whereas LL decreased from baseline (p < 0.01). The prevalence of increased CL was 35.3% at 3 months and 47.8% at 2 years, which did not represent a significant change. Postoperative cervical alignment changes were not significantly different from preoperative values regardless of the LIV (LIV ≥ L-5 or LIV-ilium, p > 0.05 for both). In a subset of patients with a maximum TK ≥ 60° (35 patients) and 3-column osteotomy (38 patients), no significant postoperative cervical changes were seen.

CONCLUSION

Increased CL is common in adult spinal deformity patients with thoracic deformities and, unlike after lumbar corrective surgery, does not appear to normalize after thoracic corrective surgery. Cervical sagittal malalignment (C2–7 SVA) also increases postoperatively. Surgeons should be aware that spontaneous cervical alignment normalization might not occur following thoracic deformity correction.

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Kristina Bianco, Robert Norton, Frank Schwab, Justin S. Smith, Eric Klineberg, Ibrahim Obeid, Gregory Mundis Jr., Christopher I. Shaffrey, Khaled Kebaish, Richard Hostin, Robert Hart, Munish C. Gupta, Douglas Burton, Christopher Ames, Oheneba Boachie-Adjei, Themistocles S. Protopsaltis and Virginie Lafage

Object

Three-column resection osteotomies (3COs) are commonly performed for sagittal deformity but have high rates of reported complications. Authors of this study aimed to examine the incidence of and intercenter variability in major intraoperative complications (IOCs), major postoperative complications (POCs) up to 6 weeks postsurgery, and overall complications (that is, both IOCs and POCs). They also aimed to investigate the incidence of and intercenter variability in blood loss during 3CO procedures.

Methods

The incidence of IOCs, POCs, and overall complications associated with 3COs were retrospectively determined for the study population and for each of 8 participating surgical centers. The incidence of major blood loss (MBL) over 4 L and the percentage of total blood volume lost were also determined for the study population and each surgical center. Complication rates and blood loss were compared between patients with one and those with two osteotomies, as well as between patients with one thoracic osteotomy (ThO) and those with one lumbar or sacral osteotomy (LSO). Risk factors for developing complications were determined.

Results

Retrospective review of prospectively acquired data for 423 consecutive patients who had undergone 3CO at 8 surgical centers was performed. The incidence of major IOCs, POCs, and overall complications was 7%, 39%, and 42%, respectively, for the study population overall. The most common IOC was spinal cord deficit (2.6%) and the most common POC was unplanned return to the operating room (19.4%). Patients with two osteotomies had more POCs (56% vs 38%, p = 0.04) than the patients with one osteotomy. Those with ThO had more IOCs (16% vs 6%, p = 0.03), POCs (58% vs 34%, p < 0.01), and overall complications (67% vs 37%, p < 0.01) than the patients with LSO. There was significant variation in the incidence of IOCs, POCs, and overall complications among the 8 sites (p < 0.01). The incidence of MBL was 24% for the study population, which varied significantly between sites (p < 0.01). Patients with MBL had a higher risk of IOCs, POCs, and overall complications (OR 2.15, 1.76, and 2.01, respectively). The average percentage of total blood volume lost was 55% for the study population, which also varied among sites (p < 0.01).

Conclusions

Given the complexity of 3COs for spinal deformity, it is important for spine surgeons to understand the risk factors and complication rates associated with these procedures. In this study, the overall incidence of major complications following 3CO procedures was 42%. Risks for developing complications included an older age (> 60 years), two osteotomies, ThO, and MBL.

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Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Benjamin Blondel, Frank Schwab, Richard Hostin, Robert Hart, Brian O'Shaughnessy, Shay Bess, Serena S. Hu, Vedat Deviren, Christopher P. Ames and International Spine Study Group

Object

Sagittal spinopelvic malalignment is a significant cause of pain and disability in patients with adult spinal deformity. Surgical correction of spinopelvic malalignment can result in compensatory changes in spinal alignment outside of the fused spinal segments. These compensatory changes, termed reciprocal changes, have been defined for thoracic and lumbar regions but not for the cervical spine. The object of this study was to evaluate postoperative reciprocal changes within the cervical spine following lumbar pedicle subtraction osteotomy (PSO).

Methods

This was a multicenter retrospective radiographic analysis of patients from International Spine Study Group centers. Inclusion criteria were as follows: adults (>18 years old) with spinal deformity treated using lumbar PSO, a preoperative C7–S1 plumb line greater than 5 cm, and availability of pre- and postoperative full-length standing radiographs.

Results

Seventy-five patients (60 women, mean age 59 years) were included. The lumbar PSO significantly improved sagittal alignment, including the C7–S1 plumb line, C7–T12 inclination, and pelvic tilt (p <0.001). After lumbar PSO, reciprocal changes were seen to occur in C2–7 cervical lordosis (from 30.8° to 21.6°, p <0.001), C2–7 plumb line (from 27.0 mm to 22.9 mm), and T-1 slope (from −38.9° to −30.4°, p <0.001). Ideal correction of sagittal malalignment (postoperative sagittal vertical alignment < 50 mm) was associated with the greatest relaxation of cervical hyperlordosis (−12.4° vs −5.7°, p = 0.037). A change in cervical lordosis correlated with changes in T-1 slope (r = −0.621, p <0.001), C7–T12 inclination (r = 0.418, p <0.001), T12–S1 angle (r = −0.339, p = 0.005), and C7–S1 plumb line (r = 0.289, p = 0.018). Radiographic parameters that correlated with changes in cervical lordosis on multivariate linear regression analysis included change in T-1 slope and change in C2–7 plumb line (r2 = 0.53, p <0.001).

Conclusions

Adults with positive sagittal spinopelvic malalignment compensate with abnormally increased cervical lordosis in an effort to maintain horizontal gaze. Surgical correction of sagittal malalignment results in improvement of the abnormal cervical hyperlordosis through reciprocal changes.

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Emmanuelle Ferrero, Barthelemy Liabaud, Jensen K. Henry, Christopher P. Ames, Khaled Kebaish, Gregory M. Mundis, Richard Hostin, Munish C. Gupta, Oheneba Boachie-Adjei, Justin S. Smith, Robert A. Hart, Ibrahim Obeid, Bassel G. Diebo, Frank J. Schwab and Virginie Lafage

OBJECTIVE

Three-column osteotomy (3CO) is a demanding technique that is performed to correct sagittal spinal malalignment. However, the impact of the 3CO level on pelvic or truncal sagittal correction remains unclear. In this study, the authors assessed the impact of 3CO level and postoperative apex of lumbar lordosis on sagittal alignment correction, complications, and revisions.

METHODS

In this retrospective study of a multicenter spinal deformity database, radiographic data were analyzed at baseline and at 1- and 2-year follow-up to quantify spinopelvic alignment, apex of lordosis, and resection angle. The impact of 3CO level and apex level of lumbar lordosis on the sagittal correction was assessed. Logistic regression analyses were performed, controlling for cofounders, to investigate the effects of 3CO level and apex level on intraoperative and postoperative complications as well as on the need for subsequent revision surgery.

RESULTS

A total of 468 patients were included (mean age 60.8 years, mean body mass index 28.1 kg/m2); 70% of patients were female. The average 3CO resection angle was 25.1° and did not significantly differ with regard to 3CO level. There were no significant correlations between the 3CO level and amount of sagittal vertical axis or pelvic tilt correction. The postoperative apex level significantly correlated with greater correction of pelvic tilt (2° per more caudal level, R = −0.2, p = 0.006). Lower-level 3CO significantly correlated with revisions for pseudarthrosis (OR = 3.88, p = 0.001) and postoperative motor deficits (OR = 2.02, p = 0.026).

CONCLUSIONS

In this study, a more caudal lumbar 3CO level did not lead to greater sagittal vertical axis correction. The postoperative apex of lumbar lordosis significantly impacted pelvic tilt. 3CO levels that were more caudal were associated with more postoperative motor deficits and revisions.

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Justin K. Scheer, Virginie Lafage, Justin S. Smith, Vedat Deviren, Richard Hostin, Ian M. McCarthy, Gregory M. Mundis, Douglas C. Burton, Eric Klineberg, Munish C. Gupta, Khaled M. Kebaish, Christopher I. Shaffrey, Shay Bess, Frank Schwab, Christopher P. Ames and the International Spine Study Group (ISSG)

Object

Spinal osteotomies for adult spinal deformity correction may include resection of all 3 spinal columns (pedicle subtraction osteotomy [PSO] and vertebral column resection [VCR]). The relationship between patient age and health-related quality of life (HRQOL) outcomes for patients undergoing major spinal deformity correction via PSO or VCR has not been well characterized. The goal of this study was to characterize that relationship.

Methods

This study was a retrospective review of 374 patients who had undergone a 3-column osteotomy (299 PSOs and 75 VCRs) and were part of a prospectively collected, multicenter adult spinal deformity database. The consecutively enrolled patients were drawn from 11 sites across the United States. Health-related QOL outcomes, according to the visual analog scale (VAS), Oswestry Disability Index (ODI), 36-Item Short-Form Health Survey (SF-36, physical component score [PCS] and mental component score), and Scoliosis Research Society-22 questionnaire (SRS), were evaluated preoperatively and 1 and 2 years postoperatively. Differences and correlations between patient age and HRQOL outcomes were investigated. Age groupings included young (age ≤ 45 years), middle aged (age 46–64 years), and elderly (age ≥ 65 years).

Results

In patients who had undergone PSO, age significantly correlated (Spearman's correlation coefficient) with the 2-year ODI (ρ = 0.24, p = 0.0450), 2-year SRS function score (ρ = 0.30, p = 0.0123), and 2-year SRS total score (ρ = 0.30, p = 0.0133). Among all patients (PSO+VCR), the preoperative PCS and ODI in the young group were significantly higher and lower, respectively, than those in the elderly. Among the PSO patients, the elderly group had much greater improvement than the young group in the 1- and 2-year PCS, 2-year ODI, and 2-year SRS function and total scores. Among the VCR patients, the young age group had much greater improvement than the elderly in the 1-year SRS pain score, 1-year PCS, 2-year PCS, and 2-year ODI. There was no significant difference among all the age groups as regards the likelihood of reaching a minimum clinically important difference (MCID) within each of the HRQOL outcomes (p > 0.05 for all). Among the PSO patients, the elderly group was significantly more likely than the young to reach an MCID for the 1-year PCS (61% vs 21%, p = 0.0077) and the 2-year PCS (67% vs 17%, p = 0.0054), SRS pain score (57% vs 20%, p = 0.0457), and SRS function score (62% vs 20%, p = 0.0250). Among the VCR patients, the young group was significantly more likely than the elderly patients to reach an MCID for the 1-year (100% vs 20%, p = 0.0036) and 2-year (100% vs 0%, p = 0.0027) PCS scores and 1-year (60% vs 0%, p = 0.0173) and 2-year (70% vs 0%, p = 0.0433) SRS pain scores.

Conclusions

The PSO and VCR are not equivalent surgeries in terms of HRQOL outcomes and patient age. Among patients who underwent PSO, the elderly group started with more preoperative disability than the younger patients but had greater improvements in HRQOL outcomes and was more likely to reach an MCID at 1 and 2 years after treatment. Among those who underwent VCR, all had similar preoperative disabilities, but the younger patients had greater improvements in HRQOL outcomes and were more likely to reach an MCID at 1 and 2 years after treatment.