Introduction Patient-reported outcome measures (PROMs) are increasingly used to aid clinical decision-making, evaluate treatment outcomes, and support quality improvement in spine care. However, to ensure valid and representative outcomes, sufficient completion rates are crucial. Research question The objective of this study is to assess PROM completion rates in routine lumbar spine surgery care and to identify patient- and hospital-level factors associated with completion. Materials and Methods Data were obtained from patients undergoing low-complex lumbar spine surgery for degeneration, with and without instrumentation, recorded in the Spine Tango Registry. PROM completion was assessed as completion of any, baseline, or follow-up PROM, and paired baseline and follow-up PROMs. Mixed-effects logistic regression models were used to evaluate associations between PROM completion and patient characteristics (e.g. age, diagnosis, surgical procedure) and to describe hospital- and country-level variability. Additionally, an exploratory survey among participating hospitals assessed PROM collection strategies. Results A total of 1810 patients from 5 countries were included. Overall, 67.3% of patients completed at least one PROM, 57.9% completed a baseline PROM, 53.3% completed a follow-up PROM and 44.4% completed paired baseline and follow-up PROMs. Completion rates declined with increasing follow-up duration. Age, diagnosis, and type of surgery were significantly associated with PROM completion. Substantial variability in PROM completion was observed between hospitals. Discussion and Conclusion PROM completion in routine lumbar spine surgery care remains suboptimal, particularly for long-term follow-up and paired PROMs. The large variability between hospitals indicates that hospital-level interventions are crucial to improve PROM completeness and ensure reliable outcome assessment.
Study designRetrospective single-center registry validation audit.ObjectiveTo quantify the impact of semi-automated, chart-adjudicated data validation workflow on case completeness and key quality indicators in the Swiss Implant Registry (SIRIS Spine).MethodsAll Swiss procedure (CHOP)-coded spine surgeries meeting SIRIS Spine inclusion criteria (01/2021-07/2025) were extracted from the hospital information system at a tertiary spine center and reconciled with SIRIS Spine entries. We screened for duplicate patient identification number entries to identify all revision surgeries, and adjudicated discrepancies by operative report review. Reoperation/revision rate analyses focused on the first recorded event. Pre-versus post-validation comparisons used chi-square tests; between-year variation and linear trend were assessed using logistic regression.ResultsValidation for data completeness increased the number of registered surgeries by 21% (N=1,425 to 1,726; p<0.001). Overall, 32% of surgery records required modification during content validation, while 68% remained unchanged (p<0.001). Of modified records, 76% were added and 24% were deleted (p<0.001). Added surgeries were most commonly reoperations/revisions (57%), followed by surgeries for degenerative disease (33%) (p<0.001). Deletions were mainly due to not meeting inclusion criteria (65%) or inaccurate case information 22%) (p<0.001). Dural tear rates changed from 9% to 10% and first-reoperation/revision rates from 10% to 17% after data validation (both p<0.001).ConclusionsAt a single-center, structured data validation improved registry completeness, particularly for revision surgery, and changed benchmark-relevant indicators. Ongoing local validation is needed to ensure reliable quality assurance, benchmarking, and research.
Diseases and injuries of the knee occupy a significant place in the structure of orthopedic pathology. The main method of knee arthritis of the III–IV degree is total knee arthroplasty (TKA). Purpose. To analyze the postoperative period after TKA without wound drainage. Methods. For the study, a homogeneous group of 140 patients was selected, their age ranged from 45 to 78 years, the diagnosis was knee arthritis of the III–IV degree. Patients were divided into 2 groups: study group — the wound was not drained (73 people), comparison group — the wound was drained (67). Results. Blood loss during surgery was comparable in both groups and ranged from 80 to 340 ml, with an average of (217.59 ± 76.19) ml in the study group and (195.6 ± 67.97) ml in the comparison group. No statistically significant difference was f ound i n b oth g roups ( p > 0 .05, p = 0 .16277). A c omparative analysis of the course of the postoperative period revealed a shorter treatment period in the study group. Refusal to drain the postoperative wound under conditions of stable hemostasis contributed to a faster recovery of hemoglobin and erythrocyte indices. ESR and CRP levels showed a tendency towards a faster reduction in inflammation in the study group. The postoperative management used did not show any differences in the healing time of the postoperative wound. The low intensity of postoperative pain according to VAS in the study group allowed to reduce the use of analgesics and shorten the patient's hospital stay by 2 days. Therefore, TKA without drainage of the postoperative wound can be considered as the method of choice. Conclusion. TKA without drainage of the wound after surgery did not cause an increase in postoperative complications in our series of operations. In addition, it reduced pain syndrome and, according to laboratory data, reduced the indicators of the inflammatory process.
Introduction Spine registries are important for advancing the field to provide evidence for clinical and health policy decision-making. Research question The objective is to introduce the Swiss Implant Registry "SIRIS Spine" as one of the world’s first mandatory nationwide spinal implant registries for selected spinal surgeries. Material and Methods SIRIS Spine is governed by the SIRIS Foundation, Switzerland. EUROSPINE is commissioned to operate the registry. Collected patient data includes demographic, clinical, and implant information and may additionally include electronic patient-reported outcome measures. Inclusion criteria are growing stepwise. Results Between the years 2021-2023, 12,815 surgeries for 11,789 patients from 91 hospitals were registered. This includes 75,522 implants from 40 manufactures. Reoperations and revisions were registered in 6.9%. The most frequent pathology was degenerative disease (61.6%), followed by osteoporotic fractures (12.4%), and non-degenerative spondylolisthesis (5.4%). The mean age was 66.8 (standard deviation (SD) 13.7) years. Women (58.7%) were slightly more frequently included than men. Almost half of the surgeries were preceded by one or several prior surgeries at the same or adjacent segment (49.6%), after excluding 1’367 patients with missing information. Discussion and Conclusion The SIRIS Spine registry has successfully captured initial data from the involved Swiss hospitals. Involvement of all key stakeholders including specialist societies has proven to be important and a clear success factor. The primary challenge identified was the complexity of inclusion criteria, which has impeded data validation. Future efforts will focus on simplifying criteria, rigorously validating data completeness and accuracy, and leveraging data for quality improvement and comparative analyses.
The Neck Disability Index (NDI) and the neck version of the Core Outcome Measures Index (COMI-neck) are two commonly used self-rating outcome instruments in patients with cervical spinal disorders. The present study aimed to create a crosswalk between them to allow the scores of one to be interpreted in terms of the other. We performed a secondary analysis of matched pairs of NDI and COMI-neck data collected in an international spine surgery registry from 624 patients (51 ± 10y; 57.2
BACKGROUND:Anterior lumbar interbody fusion (ALIF) surgery can damage nerve fibers and has been linked to retrograde ejaculation in men. In women, sexual dysfunction following ALIF is rarely investigated. The aim of this study was to investigate the frequency of postoperative changes in sexual function and incontinence in women following ALIF. METHODS:For this study, 173 female patients aged 18 to 60 years who had undergone a primary ALIF surgery in 2015 to 2022 in a large spine center to retrospectively answer a questionnaire about sexual function and incontinence pre- and postoperatively; they were also asked to rate their satisfaction with the surgery. McNemar tests were used to compare the prevalence of specific problems pre- vs postoperatively. RESULTS:Of all respondents (n = 84), 23 (27%) reported a worsening of sexual function following ALIF surgery, and these changes were persistent in 83% of those patients. Among individual symptoms of sexual dysfunction, the highest increase was observed for the prevalence of vaginal dryness, which increased from 12% preoperatively to 32% postoperatively (P < 0.001), followed by dyspareunia, which increased from 8% to 21% (P = 0.001). Urinary incontinence increased from 25% to 41% (P < 0.001). Patient age, level of surgery, and fusion material were not associated with worsening of sexual function. However, worsening of sexual function was associated with a lower level of satisfaction with the surgery outcome and a lower proportion of patients who would have the surgery again. CONCLUSIONS:Female patients undergoing ALIF should receive adequate preoperative information about potential changes in sexual function to enable them to make an informed decision. CLINICAL RELEVANCE:An improved understanding among patients will lead to more realistic patient expectations and higher patient satisfaction. LEVEL OF EVIDENCE: 4:
Initially established as a voluntary prosthesis register for total ankle replacement, the registry now enables analysis of revisions, complications, and clinical and functional outcomes-including patient-reported outcome measures-based on a period spanning more than 10 years. To allow analyses of the outcomes of ankle arthrodesis and supramalleolar osteotomies for treatment of end-stage arthritis in the future, the registry was extended by structured capturing of these procedures in 2018. While descriptive and analytical statistical evaluations of total ankle replacement are already possible today, the number of datasets on arthrodesis and supramalleolar osteotomies is still too small to support these analyses or comparative evaluations.
Os intermetatarseum is a relatively frequent accessory foot bone that rarely becomes symptomatic. We present a case of a symptomatic os intermetatarseum in a 12-year-old child, who presented to our clinic with pain during sports and prolonged physical activity. Several months ago, a midfoot sprain had occurred without any detectable fractures. The patient continued to have pain. The diagnosis of a bilateral os intermetatarseum – more prominent on the symptomatic left side – was confirmed with plain radiographs and computed tomography scanning. Surgical resection of the painful accessory bone on the left side was performed. Six weeks postoperatively the patient was asymptomatic and fully returned to sports.Das Os intermetatarseum ist ein relativ häufiger akzessorischer Fußknochen, welcher jedoch nur selten symptomatisch wird. Wir berichten über einen Fall eines symptomatischen Os intermetatarseum bei einem 12-jährigen Mädchen, das sich in unserer Klinik mit Schmerzen im Bereich des linken Fußes beim Sport und bei vermehrter Belastung vorstellte. Einige Monate im Vorfeld war es zu einer Mittelfußdistorsion gekommen. Ambulant wurden Traumafolgen bildgebend ausgeschlossen. Trotzdem beklagte das Mädchen seither Beschwerden im linken Vorfuß. Röntgenologisch zeigte sich ein Os intermetatarseum beidseits mit stärkerer Prominenz auf der schmerzhaften linken Seite. Es erfolgte die Resektion des symptomatischen Ossikels. Sechs Wochen nach der Operation war die Patientin asymptomatisch und konnte wieder ihrer sportlichen Betätigung nachgehen.
Ursprünglich als freiwilliges Endoprothesenregister für die Versorgung des oberen Sprunggelenks (OSG) etabliert, erlaubt das Register die Auswertung von Revisionen, Komplikationen sowie klinischen und funktionellen Ergebnisse unter Einschluss der Patientenperspektive nunmehr in einem Zeitverlauf von über 10 Jahren. Um darüber hinaus zukünftig auch Aussagen zum Outcome nach Arthrodesen und supramalleolären Umstellungsosteotomien als Therapie der fortgeschrittenen Arthrose des OSG treffen zu können, erfolgte im Jahr 2018 die Erweiterung des Registers um die strukturierte Erfassung dieser Verfahren. Während deskriptive und analytische statistische Auswertungen zur Endoprothetik bereits möglich sind, ist die Fallzahl für Arthrodesen und Umstellungen noch zu gering für solche Analysen oder vergleichende Auswertungen zwischen den einzelnen Therapieansätzen.
The Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) are two commonly used self-rating outcome instruments in patients with lumbar spinal disorders. No formal crosswalk between them exists that would otherwise allow the scores of one to be interpreted in terms of the other. We aimed to create such a mapping function. We performed a secondary analysis of ODI and COMI data previously collected from 3324 patients (57 ± 17y; 60.3
Fragestellung Endoprothesenregister fokussieren im Wesentlichen auf Komplikationen, Revisionsraten und Standzeiten. Diese Daten lassen sich mit begrenztem Dokumentationsaufwand unter Erfassung von Parametern wie Implantatedaten, Art des Eingriffs, Risikofaktoren (z.B. Voroperationen), OP-Datum und Datum des Folgeeingriffs eruieren. Angesichts des erheblichen Dokumentationsaufwandes wird oftmals auf Zusatzdokumentationen wie die Erfassung der Patientenperspektive verzichtet.
Surgeons need tools to provide individualised estimates of surgical outcomes and the uncertainty surrounding these, to convey realistic expectations to the patient. This study developed and validated prognostic models for patients undergoing surgical treatment of lumbar disc herniation, to predict outcomes 1 year after surgery, and implemented these models in an online prediction tool. Using the data of 1244 patients from a large spine unit, LASSO and linear regression models were fitted with 90% upper prediction limits, to predict scores on the Core Outcome Measures Index, and back and leg pain. Candidate predictors included sociodemographic factors, baseline symptoms, medical history, and surgeon characteristics. Temporal validation was conducted on 364 more recent patients at the same unit, by examining the proportion of observed outcomes exceeding the threshold of the 90% upper prediction limit (UPL), and by calculating mean bias and other calibration measures. Poorer outcome was predicted by obesity, previous spine surgery, and having basic obligatory (rather than private) insurance. In the validation data, fewer than 12% of outcomes were above the 90% UPL. Calibration plots for the model validation showed values for mean bias < 0.5 score points and regression slopes close to 1. While the model accuracy was good overall, the prediction intervals indicated considerable predictive uncertainty on the individual level. Implementation studies will assess the clinical usefulness of the online tool. Updating the models with additional predictors may improve the accuracy and precision of outcome predictions. These slides can be retrieved under Electronic Supplementary Material.
Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651–2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. The mean (± SD) mMII was 3.9 ± 5.0 (range 0–40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6–13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20–10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.
Objective. Studying of impact of a human placenta hydrolysate on regeneration of intestinal anastomosis and prophylaxis of their sutures insufficiency. Materials and methods. Experimental investigations were conducted on two groups of rabbits. In every group a simulation model of an acute strangulation ileus was created. In a one day a relaparotomy, resection of necrotized intestinal segments with anastomosing in a “side-to-side” fashion were done in rabbits of both groups. After the operation the control group rabbits have obtained a standard treatment, while in the main group the rabbits together with a standard treatment have obtained a human placenta hydrolysate preparation «Laennec». On the days 3, 5, 7 and 15th the according intestinal segments were probed for morpho-histochemical investigations. Clinical investigations were conducted in 122 patients, consisting of resection of intestinal segments with formation of anastomoses. The control group consisted of 60 patients, and the main one – in 62. The data of the control group were studied retrospectively. In the main group the patients, together with a standard treatment, a human placenta hydrolysate in a form of preparation “Laennec” was applied for prophylaxis of insufficiency of the intestinal anastomoses sutures. Results. Basing on experimental results it may be stressed, that application of preparation «Laennec» strengthens regeneration and angiogenesis in zone of anastomosis, because in animals of the main group, comparing with a control one, high mitotic index, good angiogenesis and the motor-evacuation function integrity were noted. In clinical practice the anastomotic sutures insufficiency in the control group have occurred in 13.3% of observations, and in the main group – in 1.6% of observations. Conclusion. Application of the human placenta hydrolysate for prophylaxis of the sutures insufficiency in intestinal anastomoses is affordable due to successive clinical and experimental data obtained.
In this secondary analysis of the CT and MR imaging studies of the prospective, double-blind Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) trial participants, the authors found no differences in baseline imaging characteristics between those receiving epidural corticosteroid and lidocaine and those receiving lidocaine alone injections. No imaging measures of spinal stenosis were associated with a differential response to corticosteroids, indicating that imaging parameters of spinal stenosis did not predict a response to epidural corticosteroids. BACKGROUND AND PURPOSE: Epidural steroid injections may offer little-to-no short-term benefit in the overall population of patients with symptomatic spinal stenosis compared with lidocaine alone. We investigated whether imaging could identify subgroups of patients who might benefit most. MATERIALS AND METHODS: A secondary analysis of the Lumbar Epidural Steroid Injections for Spinal Stenosis prospective, double-blind trial was performed, and patients were randomized to receive an epidural injection of lidocaine with or without corticosteroids. Patients (n = 350) were evaluated for qualitative and quantitative MR imaging or CT measures of lumbar spinal stenosis. The primary clinical end points were the Roland-Morris Disability Questionnaire and the leg pain numeric rating scale at 3 weeks following injection. ANCOVA was used to assess the significance of interaction terms between imaging measures of spinal stenosis and injectate type on clinical improvement. RESULTS: There was no difference in the improvement of disability or leg pain scores at 3 weeks between patients injected with epidural lidocaine alone compared with corticosteroid and lidocaine when accounting for the primary imaging measures of qualitative spinal stenosis assessment (interaction coefficients for disability score, -0.1; 95% CI, -1.3 to 1.2; P = .90; and for the leg pain score, 0.1; 95% CI, -0.6 to 0.8; P = .81) or the quantitative minimum thecal sac cross-sectional area (interaction coefficients for disability score, 0.01; 95% CI, -0.01 to 0.03; P = .40; and for the leg pain score, 0.01; 95% CI, -0.01 to 0.03; P = .33). CONCLUSIONS: Imaging measures of spinal stenosis are not associated with differential clinical responses following epidural corticosteroid injection.
OBJECTIVE: To determine risk factors for negative global treatment outcomes as self-assessed by patients undergoing surgical treatment for lumbar spinal stenosis (LSS). METHODS: Patients from the Spine Tango registry undergoing first-tune surgery for LSS were analyzed. The primary outcome was global treatment outcomes measured at the last available follow-up >= 3 months postoperatively using a single question rating how much the operation had helped the patient's back problem (negative = no change/ operation made things worse). A 2-level logistic mixed effects model with the treating department as the random effect was used to assess factors associated with a negative outcome. RESULTS: A total of 4504 patients from 39 departments in 10 countries were included. Overall, 14.4% of patients reported a negative global treatment outcome after an average follow-up of 1.3 years. In patients with dominant leg pain, negative outcome was associated with higher baseline back pain; in those with dominant back pain, it was associated with higher baseline back pain, ASA (American Society of Anesthesiologists) >= 3, lower age, not having rigid stabilization, not having disc herniation, and the vertebral level of the most severely affected segment (L5/S1 vs. L3/4). Four departments had significantly higher odds of a negative outcome, whereas 1 department had significantly lower odds. Three out of the 4 negative effects were related to 2 departments from 1 country. CONCLUSIONS: LSS surgery fails to help at least 1 in 10 patients. High baseline back pain is the most important factor associated with a negative treatment outcome. Department-level and potentially country-level factors of unknown origin explained a nonnegligible variation in the treatment results.
Le registre international du rachis «Spine Tango» a ete lance en 2002 afin de pouvoir comparer les efforts therapeutiques au niveau national et international et de tendre vers une harmonisation et une standardisation des traitements.
The aim of this study was to evaluate factors that distinguish between patients with adult spinal deformity (ASD) with and without an indication for surgery, irrespective of their final treatment.
Das internationale «Spine Tango»-Wirbelsäulenregister wurde 2002 gegründet, um das therapeutische Bemühen auf nationaler und internationaler Ebene vergleichen und sich in Richtung Harmonisierung und Standardisierung der Therapien bewegen zu können.