Longitudinal evaluation of external quality assessment results for CA 15-3, CA 19-9, and CA 125.

Background: Tumor markers are established laboratory tools that help to diagnose, estimate prognosis, and monitor the course of cancer. For meaningful decision-making in patient care, it is essential that methods and analytical platforms demonstrate high sensitivity, specificity, precision, and comparability. Regular participation at external quality assessment (EQA) schemes is mandatory for laboratories. Here, a longitudinal evaluation of EQA data was performed to assess the performance of tumor marker assays over time. Methods: Longitudinal data of the cancer antigens (CA) 15-3 (n = 5,492), CA 19-9 (n = 6,802), and CA 125 (n = 5,362) from 14 INSTAND EQAs conducted between 2019 and 2023 were evaluated. A median of 197, 244 and 191 laboratories participated at the EQAs for CA 15-3, CA 19-9 and CA 125, respectively. Data evaluation encompasses intra- and inter-manufacturer specific variations over time, assay precision, and adherence to the EQA limits of ±24% for CA 15-3, ±27% for CA 19-9 and ±36% for CA 125. Results: The study showed median manufacturer-dependent differences of up to 107% for CA 15-3, 99% for CA 125, and even 549% for CA 19-9 between the highest and the lowest methods over the studied period. Regarding the normalized median of all methods, the values of the most deviant methods were 0.42 for CA 15-3, 7.61 for CA 19-9, and 1.82 for CA 125. Intra-manufacturer variability was generally low, with median coefficients of variation (CV) below 10%. As the methods were evaluated according to method-specific consensus values, most participants passed the EQAs within the acceptance criteria. When the criteria were consistently set at 24%, the central 90% of participants passed the EQAs in 78.6%-100% for CA 15-3 (with exception of AX), 89.3%-100% for CA 125, and 64.3%-100% for CA 19-9. Conclusion: While intra-method precision of most analytical platforms is acceptable for all three tumor markers, considerable inter-method variability was observed over the whole studied period demonstrating the necessity for better standardization and harmonization of the methods, development of international reference materials, and comprehensive commutability studies with patient samples.

Functional outcomes and center of rotation restoration in total hip arthroplasty after acetabular fracture: A review of 367 hips.

BACKGROUND: Total hip arthroplasty (THA) after acetabular fracture is typically performed months or years later for posttraumatic arthritis after initial conservative treatment. But THA can be performed earlier after open reduction and internal fixation (ORIF) of the fracture. The aim of this study was to determine which strategy is best. The primary outcome measure was the radiological restoration of the hip's center of rotation (COR). The secondary outcome measures were the incidence of complications and the hip's functional scores. MATERIALS AND METHODS: A multicenter cohort was analyzed by splitting patients into three groups: group A (THA within 3weeks of fracture); group B (THA deferred after early ORIF); group C (THA more than 3weeks after fracture, without ORIF). Group B was separated into two subgroups: B- (THA less than 1year after ORIF) and B+ (THA more than 1year after ORIF). The demographics, surgical techniques, COR superior and lateral migration coefficient and functional scores (HHS, HOOS-PS and FJS) were recorded. The functional scores were gathered using PROMs. RESULTS: In all, 367 patients were included: 108 in group A, 69 in group B-, 113 in group B+ and 77 in group C. The mean follow-up was 5.8years [3.4 months-35years]. The mean age of the patients was 69.2years [SD 15; 26-101], 52years [SD 16; 19-83], 49years [SD 16; 16-85] and 58.1years [SD 17; 13-94], respectively (p<0.01). The mean ASA score was 2.13 [SD 0.70], 1.84 [SD 0.65], 1.67 [SD 0.63] and 1.79 [SD 0.60], respectively (p<0.01). A complex Letournel fracture was present in 63 patients (61%), 46 patients (71%), 48 patients (49%) and 38 patients (62%), respectively (p<0.01). A reinforcement cage was implanted in 38 patients (69%), 16 patients (62%), 5 patients (12%) and 19 patients (66%), respectively (p<0.01). Cement was used in 45 patients (45%), 23 patients (35%), 19 patients (18%) and 21 patients (32%), respectively (p<0.01). A graft was needed in 46 patients (46%), 35 patients (53%), 17 patients (16%) and 21 patients (48%), respectively (p<0.01). Posterior ORIF was done in 40 patients (46%), 32 patients (55%), 64 patients (61%) and 9 patients (82%), respectively (p<0.01). The COR lateral migration coefficient was significantly higher in group C with a mean of +0.17 (SD 0.85) [-0.27 to +6] compared to the other groups (p=0.02). The COR superior migration coefficient was comparable between groups, with a mean of +0.77 (SD 2.26) [-0.99 to 27], p>0.05. There were complications in 10 patients (9.2%), 6 patients (8.7%), 6 patients (5.3%) and 3 patients (3.9%), respectively, with no significant difference between groups. The PROMs were completed by 51% of patients. At the final review, the mean HHS was 79.2 (SD 21.8) and the mean HOOS-PS was 77.7 (SD 20.1) in the entire cohort, p>0.05. The mean FJS by group was 55.9 (30.2), 47.7 (SD 36.4), 66.1 (SD 30.4) and 65.8 (SD 30.3), respectively (p=0.02). DISCUSSION AND CONCLUSION: The B strategy (B+) yielded good outcomes in terms of function and COR restoration. When using this strategy, anterior ORIF preserves the native hip for a subsequent THA through a posterior approach. Strategy C also produces good functional outcomes but shifts the COR laterally. This study confirms the poor results of strategy A in previous publications. When the prognosis is poor, immediate mobilization after anterior ORIF followed by THA within 1year appears to be a good strategy (group B-). LEVEL OF EVIDENCE: IV, observational study.

Simulation on synthetic bone: A tool for teaching thoracolumbar pedicle screw placement.

INTRODUCTION: Simulation workshops for surgical training of residents are becoming popular. The gold standard for teaching thoracolumbar pedicle screw placement are cadaver labs; however, the availability of human bodies is limited. The primary objective of this study was to determine if training on a synthetic bone model improves the apprenticeship of accurate pedicle screw placement. The secondary objective was to check the influence of residents' previous experience in spine surgery. HYPOTHESIS: The main hypothesis was that theoretical learning with practical application on synthetic bone was superior to theoretical learning alone. METHODS: Twenty-three orthopedic residents were taught about free-hand pedicle screw placement using a theoretical presentation. Six residents had previous experience with screwing techniques. After randomization in two groups, 11 residents (group 1) participated in a workshop on synthetic bone, whereas 12 residents received only theoretical instruction (group 2). Each resident was asked to place two thoracic screws (T7-T11) and two lumbar screws (L1-L5) on a cadaver. Screw placement accuracy was analyzed using the Gertzbein classification on computed tomography (grades 0 and 1=accurate positioning; grades 2 and 3=malposition>2mm). RESULTS: Rates of accurate screw positioning were 64.0% and 62.5% for thoracic levels, and 72.7% and 66.6% for lumbar levels in group 1 and 2, respectively. There was no significant difference in malposition rates on cadavers between the groups (p=0.1809). A resident who was first trained by simulation had a chance of decreasing the Gertzbein score with an odds-ratio of 1.7714 [0.7710-4.1515]. The odds ratio was 4.5188 [0.0456-0.8451] when comparing residents with previous experience in spinal surgery to novice residents. DISCUSSION: Theoretical teaching associated with a simulation model is relevant for learning a surgical technique. A single simulation workshop on synthetic bone seems insufficient to improve pedicle screw placement accuracy compared to theoretical teaching alone. Progressive experience and the repetition of technical gestures during hands-on supervised learning in spine surgery with a senior surgeon had an influence on the accuracy of pedicle screw placement. LEVEL OF EVIDENCE: II.

Revision Surgery of Total Lumbar Disk Replacement: Review of 48 Cases.

STUDY DESIGN: This was a retrospective clinical review. OBJECTIVE: The objective of this study was to analyze failure mechanisms after total lumbar disk replacement (TDR) and surgical revision strategies in patients with recurrent low back pain (LBP). SUMMARY AND BACKGROUND DATA: Several reports indicate that TDR revision surgery carries a major risk and that it should not be recommended. The clinical results of posterior instrumented fusion using the prosthesis like an interbody cage have not been well analyzed. MATERIALS AND METHODS: From 2003 to 2018, 48 patients with recurrent LBP after TDR underwent revision surgery. The average age was 39 years (24-61 y). The mean follow-up was 100.4 months (24.6-207.7 mo). Clinical data, self-assessment of patient satisfaction, and Oswestry Disability Index collected at each clinical control or by phone call for the older files and radiologic assessments were reviewed. The surgical revision strategy included posterior fusion in 41 patients (group A) and TDR removal and anterior fusion in 7 patients (group B), of which 6 patients had an additional posterior fixation. RESULTS: Facet joint osteoarthritis was associated with TDR failure in 85%. In 68% the position of the prosthesis was suboptimal. Range of motion was preserved in 25%, limited in extension in 65%, and limited in flexion in 40%. Limited range of motion and facet joint osteoarthritis were significantly related (P=0.0008). The complication rate in group B was 43% including iliac vein laceration. Preoperative and 2-year follow-up Oswestry Disability Index were 25.5 and 22.0, respectively, in group A versus 27.9 and 21.3 in group B. CONCLUSIONS: Posterior osteoarthritis was the principal cause of recurrent LBP in failed TDR. The anterior approach for revision carried a major vascular risk, whereas a simple posterior instrumented fusion leads to the same clinical results. LEVEL OF EVIDENCE: Level IV.