Influence of preoperative leg pain and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry

Currently, many pre-conditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). Radiculopathy is one among them. In Switzerland it is left to the surgeon's discretion when to operate if he adheres to a list of pre-defined indications. Contraindications, however, are less clearly specified. We hypothesized that, the extent of pre-operative radiculopathy results in different benefits for patients treated with mono-segmental lumbar TDR. We used patient perceived leg pain and its correlation with physician recorded radiculopathy for creating the patient groups to be compared.

Cement volume is the most important modifiable predictor for pain relief in BKP: results from SWISSspine, a nationwide registry

Purpose The effectiveness of vertebral augmentation techniques is a currently highly debated issue. The biomechanical literature suggests that cement filling volumes may play an important role in the ‘‘dosage’’ of vertebral augmentation and its pain alleviating effect. Good clinical data about filling volumes are scarce and most patient series are small. Therefore, we investigated the predictors of pain alleviation after balloon kyphoplasty in the nationwide SWISSspine registry where cement volumes are also recorded. Methods All single-level vertebral fractures with no additional fracture stabilization and availability of at least one follow-up within 6 months after surgery were included. The following potential predictors were assessed in a multivariate logistic regression model with the group’s average pain alleviation of 41 points on VAS as the desired outcome: patient age, patient sex, diagnosis, preoperative pain, level of fracture, type of fracture, age of fracture, segmental kyphotic deformity, cement volume, vertebral body filling volume, and cement extrusions. Results There were 194 female and 82 males with an average age of 70.4 and 65.3 years, respectively. Female patients were about twice as likely for achieving the average pain relief compared to males (p = 0.04). The preoperative pain level was the strongest predictor in that the likelihood for achieving an at least 41-point pain relief increased by about 8 % with each additional point of preoperative pain (p\0.001). A thoraco-lumbar fracture had a three times higher odds for the average pain relief compared with a lumbar fracture (p = 0.03). An A.3.1 fracture only had about a third of the probability for average pain relief compared with an A.1.1 fracture (p = 0.004). Cement volumes up to 4.5 ml only had an approximately 40 % chance for a minimum 41-point pain alleviation as compared with cement volumes of at least 4.5 ml (p = 0.007). In addition, the relationship between cement volume and pain alleviation followed a dose-dependent pattern. Conclusions Cement volume was revealed as a significant predictor for pain relief in BKP. Cement volume was the third most important influential covariate and the most important modifiable and operator dependent one. The clear dose-outcome relationship between cement filling volumes and pain relief additionally supports these findings. Cement volumes of [4.5 ml seem to be recommendable for achieving relevant pain alleviation. Patient sex and fracture type and location were further significant predictors and all these covariates should be recorded and reported in future studies about the pain alleviating effectiveness of vertebral augmentation procedures.

Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study.

INTRODUCTION Surgical decompression for lumbar spinal stenosis (LSS) has been associated with poorer outcomes in patients with pronounced low back pain (LBP) as compared to patients with predominant leg pain. This cross registry study assessed potential benefits of the interlaminar coflex® device as an add-on to bony decompression alone. METHODS Patients with lumbar decompression plus coflex® (SWISSspine registry) were compared with decompressed controls (Spine Tango registry). Inclusion criteria were LSS and a preoperative back pain level of ≥5 points. 1:1 propensity score-based matching was performed. Outcome measures were back and leg pain relief, COMI score improvement, patient satisfaction, complication, and revision rates. RESULTS 50 matched pairs without residual significant differences but age were created. At the 7-9 months follow-up interval the coflex® group had higher back (p=0.014) and leg pain relief (p<0.001) and COMI score improvement (p=0.029) than the decompression group. Patient satisfaction was 90% in both groups. No revision was documented in the coflex® and one in the decompression group (2.0%). DISCUSSION In the short-term, lumbar decompression with coflex® compared with decompression alone in patients with LSS and pronounced LBP at baseline is a safe and effective treatment option that appears beneficial regarding clinical and functional outcomes. However, residual confounding of non-measured covariables may have partially influenced our findings. Also, despite careful inclusion and exclusion of cases the cross registry approach introduces a potential for selection bias that we could not totally control for and that makes additional studies necessary.

Simultaneous bilateral hip replacement reveals superior outcome and fewer complications than two-stage procedures: a prospective study including 1819 patients and 5801 follow-ups from a total joint replacement registry

Background Total joint replacements represent a considerable part of day-to-day orthopaedic routine and a substantial proportion of patients undergoing unilateral total hip arthroplasty require a contralateral treatment after the first operation. This report compares complications and functional outcome of simultaneous versus early and delayed two-stage bilateral THA over a five-year follow-up period. Methods The study is a post hoc analysis of prospectively collected data in the framework of the European IDES hip registry. The database query resulted in 1819 patients with 5801 follow-ups treated with bilateral THA between 1965 and 2002. According to the timing of the two operations the sample was divided into three groups: I) 247 patients with simultaneous bilateral THA, II) 737 patients with two-stage bilateral THA within six months, III) 835 patients with two-stage bilateral THA between six months and five years. Results Whereas postoperative hip pain and flexion did not differ between the groups, the best walking capacity was observed in group I and the worst in group III. The rate of intraoperative complications in the first group was comparable to that of the second. The frequency of postoperative local and systemic complication in group I was the lowest of the three groups. The highest rate of complications was observed in group III. Conclusions From the point of view of possible intra- and postoperative complications, one-stage bilateral THA is equally safe or safer than two-stage interventions. Additionally, from an outcome perspective the one-stage procedure can be considered to be advantageous.

Benchmarking in the SWISSspine registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of "coverage with evidence development". Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study.

Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango

Spine Tango is the first and only International Spine Registry in operation to date. So far, only surgical spinal interventions have been recorded and no comparable structured and comprehensive documentation instrument for conservative treatments of spinal disorders is available. This study reports on the development of a documentation instrument for the conservative treatment of spinal disorders by using the Delphi consensus method. It was conducted with a group of international experts in the field. We also assessed the usability of this new assessment tool with a prospective feasibility study on 97 outpatients and inpatients with low back or neck pain undergoing conservative treatment. The new 'Spine Tango conservative' questionnaire proved useful and suitable for the documentation of pathologies, conservative treatments and outcomes of patients with low back or neck problems. A follow-up questionnaire seemed less important in the predominantly outpatient setting. In the feasibility study, between 43 and 63% of patients reached the minimal clinically important difference in pain relief and Core Outcome Measures Index at 3 months after therapy; 87% of patients with back pain and 85% with neck pain were satisfied with the received treatment. With 'Spine Tango conservative' a first step has been taken to develop and implement a complementary system for documentation and evaluation of non-surgical spinal interventions and outcomes within the framework of the International Spine Registry. It proved useful and feasible in a first pilot study, but it will take the experience of many more cases and therapists to develop a version similarly mature as the surgical instruments of Spine Tango.

Five-year results of cervical disc prostheses in the SWISSspine registry

BACKGROUND: The Swiss Federal Office of Public Health demanded a nationwide HTA-registry for cervical total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of cervical TDA. MATERIALS AND METHODS: Three hundred thirty-two cases treated between 3.2005 and 6.2006 who were eligible for 5 years follow-ups were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 84.6, 74.4, 50.6 and 64.8 %, respectively. Outcome measures were neck and arm pain, medication, quality of life, intraoperative and postoperative complication and revision rates. In addition, segmental mobility, ossification, adjacent and distant segment degeneration were analyzed at the 5-year follow-up. RESULTS: There was significant, clinically relevant and lasting reduction of neck (preop/postop 60/21 VAS points) and arm pain (preop/postop VAS 67/17) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.39/0.82 EQ-5D points) until the 5-year follow-up. The rates for intraoperative and early postoperative complications were 0.6 and 7.2 %, respectively. In 0.6 % an early and in 3.9 % a late revision surgery was performed. At the 5-year follow-up, the average range of motion of the mobile segments (88.2 %) was 10.2°. In 40.7 % of the patients osteophytes at least potentially affecting range of motion were seen. CONCLUSIONS: Cervical TDA appeared as safe and efficient in long-term pain alleviation, consequent reduction of pain killer consumption and in improvement of quality of life. The improvement is stable over the 5 years postoperative period. The vast majority of treated segments remained mobile after 5 years, although 40.7 % of patients showed osteophytes.