Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. METHODS: Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. RESULT: Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. CONCLUSIONS: In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Bone Allograft Pedicle Screw Augmentation: A Biomechanical Study.

STUDY DESIGN: We performed a comprehensive cadaveric biomechanical study to compare the fixation strength of primary screws, screws augmented with bone allograft, and screws augmented with polymethylmethacrylate cement. OBJECTIVE: To evaluate a novel technique for screw augmentation using morselized cortico-cancellous bone allograft to fill the widened screw track of failed pedicle screws. BACKGROUND: To date, there are no known biological methods available for failed pedicle screw augmentation or fixation. MATERIALS AND METHODS: Biomechanical tests were performed using 2 different testing modalities to quantify fixation strength including axial screw pullout and progressive cyclic displacement tests. RESULTS: Fifty vertebrae were instrumented with pedicle screws. Our study showed that bone allograft augmentation using the same diameter screw was noninferior to the fixation strength of the initial screw. In the axial pullout test, screws undergoing bone allograft repair failed at 25% lower loads compared with native screws, and screws augmented with cement showed approximately twice as much strength compared with native screws. In the cyclic displacement test, screws fixed with cement resisted loosening the best of all the groups tested. However, screws augmented with bone graft were found to have an equal strength to native screw purchase. our study did not find a correlation with bone mineral density as a predictor for failure in axial pullout or cyclic displacement tests. CONCLUSION: Bone allograft augmentation for pedicle screw fixation was noninferior to the initial screw purchase in this biomechanical study. This bone allograft technique is a viable option for screw fixation in the revision setting when there is significant bone loss in the screw track.

Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.

STUDY DESIGN: Prospective, multicenter, international, observational study. OBJECTIVE: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery. METHODS: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively. RESULTS: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches. CONCLUSION: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.

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.

Custom-made acetabular revision arthroplasty for pelvic discontinuity: Can we handle the challenge? : a prospective cohort study.

AIMS: The aim of this study was to assess the clinical and radiological results of patients who were revised using a custom-made triflange acetabular component (CTAC) for component loosening and pelvic discontinuity (PD) after previous total hip arthroplasty (THA). METHODS: Data were extracted from a single centre prospective database of patients with PD who were treated with a CTAC. Patients were included if they had a follow-up of two years. The Hip Disability and Osteoarthritis Outcome Score (HOOS), modified Oxford Hip Score (mOHS), EurQol EuroQoL five-dimension three-level (EQ-5D-3L) utility, and Numeric Rating Scale (NRS), including visual analogue score (VAS) for pain, were gathered at baseline, and at one- and two-year follow-up. Reasons for revision, and radiological and clinical complications were registered. Trends over time are described and tested for significance and clinical relevance. RESULTS: A total of 18 females with 22 CTACs who had a mean age of 73.5 years (SD 7.7) were included. A significant improvement was found in HOOS (p < 0.0001), mOHS (p < 0.0001), EQ-5D-3L utility (p = 0.003), EQ-5D-3L NRS (p = 0.013), VAS pain rest (p = 0.008), and VAS pain activity (p < 0.0001) between baseline and final follow-up. Minimal clinically important improvement in mOHS and the HOOS Physical Function Short Form (HOOS-PS) was observed in 16 patients (73%) and 14 patients (64%), respectively. Definite healing of the PD was observed in 19 hips (86%). Complications included six cases with broken screws (27%), four cases (18%) with bony fractures, and one case (4.5%) with sciatic nerve paresthesia. One patient with concurrent bilateral PD had revision surgery due to recurrent dislocations. No revision surgery was performed for screw failure or implant breakage. CONCLUSION: CTAC in patients with THA acetabular loosening and PD can result in stable constructs and significant improvement in functioning and health-related quality of life at two years' follow-up. Further follow-up is necessary to determine the mid- to long-term outcome.Cite this article: Bone Jt Open 2023;4(2):53-61.

Scoping review of early pain-related outcome domains and measurement instruments after degenerative lumbar spine surgery.

BACKGROUND: Optimization of perioperative pain interventions in lumbar spine surgery could reduce the incidence of acute and persistent postoperative pain and opioid consumption. Standardization in early outcome measurement provides a solid foundation for future clinical and research practices and should be integrated in core outcome sets for long-term treatment outcome evaluations. This scoping review provides an overview of outcomes used when evaluating early perioperative pain interventions after lumbar spine surgery. OBJECTIVES: To create an overview of outcome domains and measurement instruments previously used in research on perioperative pain management for degenerative lumbar spine surgery. EVIDENCE REVIEW: A scoping review was performed to identify articles comprising outcome evaluations in adult patients who undergo degenerative lumbar spine surgery, mentioning perioperative pain interventions. 75 articles were included for review. Data on study characteristics, outcome domains and measurement instruments were extracted and structured using the three-tiered hierarchy of Porter. FINDINGS: 12 outcome domains were identified: pain intensity (93.3%), adverse events (76%), analgesic consumption (70.7%), length of stay (52%), patient satisfaction (24%), daily functioning (22.7%), (early) mobilization (22.7%), quality of life (12%), mortality (9.3%), quality of recovery (6.7%), physical function (4%), and quality of sleep (2.7%). 63 corresponding measurement instruments were found. CONCLUSIONS: This review portrays an extensive overview of outcome measurements used in perioperative pain management in lumbar spine surgery. A lack of consensus on the set of indicators exists. This scoping review is a call for action to create consensus on how to evaluate perioperative pain interventions in degenerative lumbar spine surgery.

Non-surgical treatment for adult spinal deformity: results of an intensive combined physical and psychological programme for patients with adult spinal deformity and chronic low back pain-a treatment-based cohort study.

OBJECTIVES: No evidence-based treatment exists for adult spinal deformity (ASD) patients with chronic low back pain (CLBP). AIM OF THIS STUDY: evaluate a combined physical and psychological programme (CPPP) for ASD patients with CLBP and to compare this with a non-ASD-cohort with CLBP. METHODS: Data were extracted from the database of CLBP-patients for whom surgery is not an option and completed CPPP. Two cohorts were selected: an ASD-cohort (n = 80) based on a Cobb angle of > 10° and a consecutive age- and gender-matched non-ASD-cohort (n = 240). PRIMARY OUTCOME: functional status (Oswestry Disability Index; ODI). SECONDARY OUTCOMES: pain intensity, self-efficacy and quality of life. ASSESSMENTS: pre and post treatment, one-month and one-year follow-up (FU). CLINICAL RELEVANCE: minimal important clinical change (MCIC; ODI 10 points), patient acceptable symptom state (PASS; ODI ≤ 22). RESULTS: Demographics ASD-cohort: 79% female, mean age 50.9 (± 14.1) years, mean CLBP duration 15.5 (± 12.5) years, mean Cobb angle 21.4 (± 9.4)°. Non-ASD-cohort: not significantly different. Both cohorts improved in functional status (F[1,318] = 142.982, p < .001; r = 0.31). The ASD-cohort improved from mean ODI 39.5(± 12.0) at baseline to mean ODI 31.8(± 16.5) at one-year FU. CLINICAL RELEVANCE: 51% of the ASD patients reached MCIC and 33% reached a PASS. An interaction effect is shown between time and both cohorts (F[1,318] = 8.2, p = .004; r = 0.03); however, not clinically relevant. All secondary outcomes: improvement at one-year FU. CONCLUSION: This is the first study showing beneficial outcomes of a non-surgical treatment in selected ASD patients with longstanding CLBP. Improvement is shown in functional status, and appeared equivalent to the non-ASD cohort. LEVEL OF EVIDENCE 1: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Supine Traction Versus Prone Bending Radiographs for Assessing the Curve Flexibility in Spinal Deformity.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: No consensus exists among surgeons on which radiologic method to prefer for the assessment of curve flexibility in spinal deformity. The objective of this study was to evaluate the difference in curve correction on supine traction radiographs versus prone side bending radiographs. METHODS: A retrospective analysis of idiopathic scoliosis (IS), degenerative idiopathic scoliosis (DIS) and de novo degenerative lumbar scoliosis (DNDLS) patients was performed on supine traction as well as prone bending films (when available). Age, weight, traction force, diagnosis and Cobb angles of the primary and secondary curves were extracted. Differences in curve correction (percentages) on traction versus prone bending radiographs were analyzed for the primary and secondary curve. Subgroup analyses were performed for the 3 different diagnoses. RESULTS: In total, 170 patients were eligible for inclusion. 43 were diagnosed with IS, 58 with DIS and 69 with DNDLS. For the primary curve, greater curve correction was obtained with bending in the DNDLS group (P < 0.001). In the DIS group, there was a trend toward more correction on bending (P = 0.054). In de IS group no difference was found. For the secondary curve, bending showed more curve correction in the IS and DIS group (P = 0.002 and P <0.001). No difference was found in the DNDLS group. CONCLUSION: Compared to traction radiographs, bending radiographs better serve the purpose of curve flexibility assessment of IS, DIS and DNDLS spinal deformity, despite the fact that patients are exposed to more radiation.

Targeting self-efficacy more important than dysfunctional behavioral cognitions in patients with longstanding chronic low back pain; a longitudinal study.

BACKGROUND: Multidisciplinary pain management programs based on cognitive behavioral training (CBT) principles have been shown moderately effective in improving daily functioning in patients with chronic low back pain (CLBP). To optimize health-related outcomes as daily functioning, a clear understanding of the working mechanisms of these programs is warranted. Being confident to achieve a desired outcome, i.e. self-efficacy, is suggested to be a more potent determinant for beneficial treatment outcomes than restructuring the patient's dysfunctional behavioral cognitions (pain catastrophizing and fear of movement [FoM]), but the evidence is scarce. The objective of this study was twofold: 1) to determine whether a two-week pain management program resulted in post-treatment improvements in self-efficacy and decreased dysfunctional behavioral cognitions in patients with CLBP, and 2) to examine the unique contribution of self-efficacy to improvement in post-treatment disability. METHODS: A secondary analysis of an historical cohort study was performed, including 524 patients (59% females). PRIMARY OUTCOME: functional status (Oswestry Disability Index v2.1a). SECONDARY OUTCOMES: catastrophizing (Pain Catastrophizing Scale), FoM (Tampa Scale for Kinesiophobia), and self-efficacy (Pain Self-Efficacy Questionnaire). ASSESSMENTS: pre-, post-treatment, 1, and 12-months follow-up. Paired Student's t-tests were applied and clinical relevancy of improvements was described using minimal clinical important changes. Adjusted multivariate linear regression analyses were performed to explore the unique contribution of self-efficacy. RESULTS: The mean age of patients was 46 (SD = 9.5) years and they had longstanding CLBP (mean 12.5 [SD = 10.8] years). Mean functional status, self-efficacy, and dysfunctional behavioral cognitions improved significantly at post-treatment, with improvements maintained at 12 months follow-up. Post-treatment relevant improvements in self-efficacy and dysfunctional behavioral cognitions ranged from 62.4% (FoM) to 68.7% (self-efficacy). Post-treatment self-efficacy improved the model explaining post-treatment functional disability (basic model R2 = 0.49, F(6,517) = 83.67, p < 0.001; final model R2 = 0.57, F(8,515) = 85.20, p < 0.001). This was further substantiated by the relative contribution (standardized betas) of self-efficacy: 5.67 times more than catastrophizing and 9.75 times more than FoM. CONCLUSIONS: Targeting self-efficacy contributes to fast improvement in functional status for selected and motivated patients with persistent CLBP. In pain management programs and (online) self-management programs for CLBP, targeting patients' self-efficacy should have a prominent place.

Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).

BACKGROUND CONTEXT: Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements. PURPOSE: The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery. STUDY DESIGN: Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity. OUTCOME MEASURES: Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%). RESULTS: Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling. CONCLUSIONS: In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.

Good results at 2-year follow-up of a custom-made triflange acetabular component for large acetabular defects and pelvic discontinuity: a prospective case series of 50 hips.

Background and purpose - Custom triflange acetabular components (CTACs) are suggested as good solutions for large acetabular defects in revision total hip arthroplasty. However, high complication rates have been reported and most studies are of limited quality. This prospective study evaluates the performance of a CTAC in patients with large acetabular defects including pelvic discontinuity.Patients and methods - Prospectively collected data of 49 consecutive patients (50 hips), who underwent an acetabular revision with a CTAC were analyzed. Follow-up (FU) was 2 years. The median age of the patients was 68 years (41-89) and 41 were women. Primary outcomes were re-revision of the CTAC and differences between the modified Oxford Hip Score (mOHS) preoperatively and at 2-year follow-up. Secondary outcomes included several patient-reported outcomes (PROMs), radiological results, complications, and a comparison between hips with and without pelvic discontinuity (PD).Results - 1 patient (1 hip) was lost to the 2-year FU. No CTAC needed re-revision. The preoperative and 2-year FU mOHS were available in 40 hips and improved statistically significantly. All of the other secondary outcomes improved over time. 5 hips (of 45 with radiological 2-year FU) had loosening of screws. 8 hips had complications, including 3 persistent wound leakage, 3 pelvic fractures, and 1 dislocation. The mOHS and complication rate were similar in hips with and without PD.Interpretation - Reconstruction of large acetabular defects with and without PD with this CTAC showed good improvement in patient-reported daily functioning, high patient-reported satisfaction, few complications, and no re-revisions at 2-year FU.

No added value of 2-year radiographic follow-up of fusion surgery for adolescent idiopathic scoliosis.

PURPOSE: For fusion surgery in adolescent idiopathic scoliosis (AIS) consensus exists that a 2-year radiographic follow-up assessment is needed. This standard lacks empirical evidence. The purpose of this study was to investigate the radiographic follow-up after corrective surgery in AIS, from pre-until 2 years postoperative. METHODS: In this historical cohort study, 63 patients surgically treated for AIS, age ≤ 25 years, with 2-year radiographic follow-up, were enrolled. The primary outcome measure was the major Cobb angle. Secondary outcomes were coronal and sagittal spino-pelvic parameters, including proximal junction kyphosis (PJK) and distal adding-on. Change over time was analyzed using a repeated measures ANOVA. RESULTS: The major curve Cobb angle showed a statistically significant change for pre- to 1 year postoperative, but not for 1- to 2-year follow-up. Seven out of 63 patients did show a change exceeding the error of measurement (5°) from 1- to 2-year follow-up (range -8° to +7°), of whom 2 patients showed curve progression and 5 showed improvement. PJK or distal adding-on was not observed. CONCLUSIONS: No statistically significant changes in major curve Cobb angle were found during postsurgical follow-up, or in adjacent non-fused segments. The findings of this study are not supportive for routine radiographs 2 years after fusion surgery in AIS patients.

The Natural History of Progression in Adult Spinal Deformity: A Radiographic Analysis.

STUDY DESIGN: Historical cohort study. OBJECTIVE: To evaluate progression in the coronal and sagittal planes in nonsurgical patients with adult spinal deformity (ASD). METHODS: A retrospective analysis of nonsurgical ASD patients between 2005 and 2017 was performed. Magnitude of the coronal and sagittal planes were compared on the day of presentation and at most recent follow-up. Previous reported prognostic factors for progression in the coronal plane, including the direction of scoliosis, curve magnitude, and the position of the intercrest line (passing through L4 or L5 vertebra), were studied. RESULTS: Fifty-eight patients were included with a mean follow-up of 59.8 ± 34.5 months. Progression in the coronal plane was seen in 72% of patients. Mean Cobb angle on the day of presentation and most recent follow-up was 37.2 ± 14.6° and 40.8° ± 16.5°, respectively. No significant differences were found in curve progression in left- versus right-sided scoliosis (3.3 ± 7.1 vs 3.7 ± 5.4, P = .81), Cobb angle <30° versus ≥30° (2.6 ± 5.0 vs 4.3 ± 6.5, P = .30), or when the intercrest line passed through L4 rather than L5 vertebra (3.4 ± 5.0° vs 3.8 ± 7.1°, P = .79). No significant differences were found in the sagittal plane between presentation and most recent follow-up. CONCLUSIONS: This is the first study that describes progression in the coronal and sagittal planes in nonsurgical patients with ASD. Previous reported prognostic factors were not confirmed as truly relevant. Although progression appears to occur, large variation exists and these results may not be directly applicable to the individual patient.

Mechanical Stability of the Prodisc-C Vivo Cervical Disc Arthroplasty: A Preliminary, Observational Study Using Radiostereometric Analysis.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To investigate the primary stability of the Prodisc-C Vivo cervical disc arthroplasty with regard to the adjacent cervical vertebrae using radiostereometric analysis (RSA), and to monitor its clinical performance. METHODS: Sixteen patients with degenerative cervical disc disease were included. RSA radiographs were obtained at the first postoperative day, at 6 weeks, 3 months, and 6 months postoperatively. Migration (translation [mm]) of the superior and inferior implant components were measured with model-based RSA, expressed along the 3 orthogonal axes, and calculated as total translation. Clinical outcomes were Neck Disability Index, numeric rating scales for neck and arm pain, Likert-type scales for satisfaction, and adverse events. Range of motion was reported as C2-C7 flexion-extension mobility (ROM). RESULTS: At final follow-up, no significant increase over time in median total translation was found. One inferior and 3 superior components subsided but were asymptomatic. ROM remained stable and clinical outcomes improved over time. Although 3 patients were unsatisfied and 3 adverse events occurred, this was not related to translation of the components. CONCLUSIONS: On a group level, both components of the Prodisc-C Vivo cervical disc arthroplasty remained stable over time and below the clinical threshold of 1 mm. Individual outliers for translation were not clinically relevant and probably related to settling of the components into the vertebral endplates. RSA allowed us to perform a preliminary but accurate study on the micromotion of a new cervical disc replacement in a small sample size, without putting large numbers of patients at risk.

Screw-Related Complications After Instrumentation of the Osteoporotic Spine: A Systematic Literature Review With Meta-Analysis.

STUDY DESIGN: Systematic literature review with meta-analysis. OBJECTIVE: Osteoporosis is common in elderly patients, who frequently suffer from spinal fractures or degenerative diseases and often require surgical treatment with spinal instrumentation. Diminished bone quality impairs primary screw purchase, which may lead to loosening and its sequelae, in the worst case, revision surgery. Information about the incidence of spinal instrumentation-related complications in osteoporotic patients is currently limited to individual reports. We conducted a systematic literature review with the aim of quantifying the incidence of screw loosening in osteoporotic spines. METHODS: Publications on spinal instrumentation of osteoporotic patients reporting screw-related complications were identified in 3 databases. Data on screw loosening and other local complications was collected. Pooled risks of experiencing such complications were estimated with random effects models. Risk of bias in the individual studies was assessed with an adapted McHarm Scale. RESULTS: From 1831 initial matches, 32 were eligible and 19 reported screw loosening rates. Studies were heterogeneous concerning procedures performed and risk of bias. Screw loosening incidences were variable with a pooled risk of 22.5% (95% CI 10.8%-36.6%, 95% prediction interval [PI] 0%-81.2%) in reports on nonaugmented screws and 2.2% (95% CI 0.0%-7.2%, 95% PI 0%-25.1%) in reports on augmented screws. CONCLUSIONS: The findings of this meta-analysis suggest that screw loosening incidences may be considerably higher in osteoporotic spines than with normal bone mineral density. Screw augmentation may reduce loosening rates; however, this requires confirmation through clinical studies. Standardized reporting of prespecified complications should be enforced by publishers.

Can patient-reported profiles avoid unnecessary referral to a spine surgeon? An observational study to further develop the Nijmegen Decision Tool for Chronic Low Back Pain.

INTRODUCTION: Chronic Low Back Pain (CLBP) is a heterogeneous condition with lack of diagnostic clarity. Therapeutic interventions show small effects. To improve outcomes by targeting interventions it is recommended to develop a triage system to surgical and non-surgical treatments based on treatment outcomes. The objective of the current study was to develop and internally validate prognostic models based on pre-treatment patient-reported profiles that identify patients who either respond or do not respond to two frequently performed treatments (lumbar spine surgery and multidisciplinary pain management program). METHODS: A consecutive cohort study in a secondary referral spine center was performed. The study followed the recommendations of the PROGRESS framework and was registered in the Dutch Trial Register (NTR5946). Data of forty-seven potential pre-consultation (baseline) indicators predicting 'response' or 'non-response' at one-year follow-up for the two treatments were obtained to develop and validate four multivariable logistic regression models. The source population consisted of 3,410 referred CLBP-patients. Two treatment cohorts were defined: elective 'spine surgery' (n = 217 [6.4%]) and multidisciplinary bio-psychosocial 'pain management program' (n = 171 [5.0%]). Main inclusion criteria were age ≥18, CLBP (≥6 months), and not responding to primary care treatment. The primary outcome was functional ability: 'response' (Oswestry Disability Index [ODI] ≤22) and 'non-response' (ODI ≥41). RESULTS: Baseline indicators predictive of treatment outcome were: degree of disability (all models), ≥2 previous spine surgeries, psychosocial complaints, age (onset <20 or >50), and patient expectations of treatment outcomes. The explained variances were low for the models predicting response and non-response to pain management program (R2 respectively 23% and 26%) and modest for surgery (R2 30% and 39%). The overall performance was acceptable (c-index; 0.72-0.83), the model predicting non-response to surgery performed best (R2 = 39%; c-index = 0.83). CONCLUSION: This study was the first to identify different patient-reported profiles that predict response to different treatments for CLBP. The model predicting 'non-response' to elective lumbar spine surgery performed remarkably well, suggesting that referrals of these patients to a spine surgeon could be avoided. After external validation, the patient-reported profiles could potentially enhance timely patient triage to the right secondary care specialist and improve decision-making between clinican and patient. This could lead to improved treatment outcomes, which results in a more efficient use of healthcare resources.

Does Operative or Nonoperative Treatment Achieve Better Results in A3 and A4 Spinal Fractures Without Neurological Deficit?: Systematic Literature Review With Meta-Analysis.

STUDY DESIGN: Systematic literature review with meta-analysis. OBJECTIVE: Thoracolumbar (TL) fractures can be treated conservatively or surgically. Especially, the treatment strategy for incomplete and complete TL burst fractures (A3 and A4, AOSpine classification) in neurologically intact patients remains controversial. The aim of this work was to collate the clinical evidence on the respective treatment modalities. METHODS: Searches were performed in PubMed and the Web of Science. Clinical and radiological outcome data were collected. For studies comparing operative with nonoperative treatment, the standardized mean differences (SMD) for disability and pain were calculated and methodological quality and risk of bias were assessed. RESULTS: From 1929 initial matches, 12 were eligible. Four of these compared surgical with conservative treatment. A comparative analysis of radiological results was not possible due to a lack of uniform reporting. Differences in clinical outcomes at follow-up were small, both between studies and between treatment groups. The SMD was 0.00 (95% CI -0.072, 0.72) for disability and -0.05 (95% CI -0.91, 0.81) for pain. Methodological quality was high in most studies and no evidence of publication bias was revealed. CONCLUSIONS: We did not find differences in disability or pain outcomes between operative and nonoperative treatment of A3 and A4 TL fractures in neurologically intact patients. Notwithstanding, the available scores have been developed and validated for degenerative diseases; thus, their suitability in trauma may be questionable. Specific and uniform outcome parameters need to be defined and enforced for the evaluation of TL trauma.

Which patient-reported factors predict referral to spinal surgery? A cohort study among 4987 chronic low back pain patients.

PURPOSE: It is unknown which chronic low back pain (CLBP) patients are typically referred to spinal surgery. The present study, therefore, aimed to explore which patient-reported factors are predictive of spinal surgery referral among CLBP patients. METHODS: CLBP patients were consecutively recruited from a Dutch orthopedic hospital specialized in spine care (n = 4987). The outcome of this study was referral to spinal surgery (yes/no), and was assessed using hospital records. Possible predictive factors were assessed using a screening questionnaire. A prediction model was constructed using logistic regression, with backwards selection and p < 0.10 for keeping variables in the model. The model was internally validated and evaluated using discrimination and calibration measures. RESULTS: Female gender, previous back surgery, high intensity leg pain, somatization, and positive treatment expectations increased the odds of being referred to spinal surgery, while being obese, having comorbidities, pain in the thoracic spine, increased walking distance, and consultation location decreased the odds. The model's fit was good (X 2 = 10.5; p = 0.23), its discriminative ability was poor (AUC = 0.671), and its explained variance was low (5.5%). A post hoc analysis indicated that consultation location was significantly associated with spinal surgery referral, even after correcting for case-mix variables. CONCLUSION: Some patient-reported factors could be identified that are predictive of spinal surgery referral. Although the identified factors are known as common predictive factors of surgery outcome, they could only partly predict spinal surgery referral.

Computational anatomy of the dens axis evaluated by quantitative computed tomography: Implications for anterior screw fixation.

The surgical fracture fixation of the odontoid process (dens) of the second cervical vertebra (C2/axis) is a challenging procedure, particularly in elderly patients affected by bone loss, and includes screw positioning close to vital structures. The aim of this study was to provide an extended anatomical knowledge of C2, the bone mass distribution and bone loss, and to understand the implications for anterior screw fixation. One hundred and twenty standard clinical quantitative computed tomography (QCT) scans of the intact cervical spine from 60 female and 60 male European patients, aged 18-90 years, were used to compute a three-dimensional statistical model and an averaged bone mass model of C2. Shape and size variability was assessed via principal component analysis (PCA), bone mass distribution by thresholding and via virtual core drilling, and the screw placement via virtual positioning of screw templates. Principal component analysis (PCA) revealed a highly variable anatomy of the dens with size as the predominant variation according to the first principal component (PC) whereas shape changes were primarily described by the remaining PCs. The bone mass distribution demonstrated a characteristic 3D pattern, and remained unchanged in the presence of bone loss. Virtual screw positioning of two 3.5 mm dens screws with a 1 mm safety zone was possible in 81.7% in a standard, parallel position and in additional 15.8% in a twisted position. The approach permitted a more detailed anatomical assessment of the dens axis. Combined with a preoperative QCT it may further improve the diagnostic procedure of odontoid fractures. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2154-2163, 2017.

A Custom-made Acetabular Implant for Paprosky Type 3 Defects.

Acetabular revision is a challenging operation, especially when dealing with major bone loss and poor bone quality. This article describes a detailed approach to defect analysis, including measurement of bone deficiency and bone quality. A custom-made titanium implant, with precisely outlined flanges to the host bones of the ilium, ischium, and pubis, taking into account the bone quality for optimal screw purchase, was used to reconstruct the acetabular defect. Preliminary results for 12 patients who were retrospectively reviewed after a minimum follow-up of 18 months were promising. [Orthopedics. 2017; 40(1):e195-e198.].