Mechanical failure of distal femur mega prosthesis due to polyaryl-ether-ether-ketone (PEEK) hinge component.

BACKGROUND: Polyaryl-ether-ether-ketone (PEEK) has gained popularity as a substrate for orthopaedic hardware due to its desirable properties such as heat and deformation resistance, low weight, and ease of manufacturing. However, we observed a relatively high failure rate of PEEK-based hinges in a distal femur reconstruction system. In this study, we aimed to evaluate the proportion of patients who experienced implant failure, analyse the mechanism of failure, and document the associated clinical findings. METHODS: We conducted a retrospective cohort study, reviewing the medical charts of 56 patients who underwent distal femur resection and reconstruction with a PEEK Optima hinge-based prosthesis between 2004 and 2018. Concurrently, we performed a clinical and biomechanical failure analysis. RESULTS: PEEK component failure occurred in 21 out of 56 patients (37.5%), with a mean time to failure of 63.2 months (range: 13-144 months, SD: 37.9). The survival distributions of PEEK hinges for males and females were significantly different (chi-square test, p-value = 0.005). Patient weight was also significantly associated with the hazard of failure (Wald's test statistic, p-value = 0.031). DISCUSSION: Our findings suggest that PEEK hinge failure in a distal femur reconstruction system is correlated with patient weight and male gender. Retrieval analysis revealed that failure was related to fretting and microscopic fractures due to cyclic loading, leading to instability and mechanical failure of the PEEK component in full extension. Further assessment of PEEK-based weight bearing articulating components against metal is warranted.

The influence of femoral lytic tumors segmentation on autonomous finite element analysis.

BACKGROUND: The validated CT-based autonomous finite element system Simfini (Yosibash et al., 2020) is used in clinical practice to assist orthopedic oncologists in determining the risk of pathological femoral fractures due to metastatic tumors. The finite element models are created automatically from CT-scans, assigning to lytic tumors a relatively low stiffness as if these were a low-density bone tissue because the tumors could not be automatically identified. METHODS: The newly developed automatic deep learning algorithm which segments lytic tumors in femurs, presented in (Rachmil et al., 2023), was integrated into Simfini. Finite element models of twenty femurs from ten CT-scans of patients with femoral lytic tumors were analyzed three times using: the original methodology without tumor segmentation, manual segmentation of the lytic tumors, and the new automatic segmentation deep learning algorithm to identify lytic tumors. The influence of explicitly incorporating tumors in the autonomous finite element analysis on computed principal strains is quantified. These serve as an indicator of femoral fracture and are therefore of clinical significance. FINDINGS: Autonomous finite element models with segmented lytic tumors had generally larger strains in regions affected by the tumor. The deep learning and manual segmentation of tumors resulted in similar average principal strains in 19 regions out of the 23 regions within 15 femurs with lytic tumors. A high dice similarity score of the automatic deep learning tumor segmentation did not necessarily correspond to minor differences compared to manual segmentation. INTERPRETATION: Automatic tumor segmentation by deep learning allows their incorporation into an autonomous finite element system, resulting generally in elevated averaged principal strains that may better predict pathological femoral fractures.

Does cryotherapy decrease the local recurrence rate in the treatment of an aneurysmal bone cyst? A comparative assessment.

Curettage with or without the use of adjuvants is the standard of care in the treatment of an aneurysmal bone cyst (ABC). Historically, our approach combined curettage, high-speed burr drilling, and cryoablation. However, treatments varied based on age, tumor location, and surgeon preference. We asked: (1) Does cryoablation in addition to curettage and burr drilling decrease the local recurrence rates? (2) Are there any risk factors for the local recurrence rate? (3) Does cryoablation improve postsurgical functional outcomes in these patients? Patients treated for an ABC, between January 2006 and December 2019 were included in this retrospective analysis. Patient and surgical characteristics, such as age, gender, tumor location, type of treatment, time of follow-up, recurrence rate, and functional outcome measured by the Musculoskeletal Tumor Society Score 1993 (MSTS93) score were compared between those treated with and without cryoablation. Both groups, without cryoablation (n = 88) and with cryoablation (n = 42), showed no significant difference in local recurrence rates (9.1% vs. 7.1%, p = 0.553) and functional outcomes as measured by the MSTS93 score (28.9 vs. 27.8, p = 0.262). Risk factors analyzed did not significantly affect local recurrence risk, except for secondary ABC diagnosis (p = 0.017). The cryoablation group had a more extended follow-up (45.6 vs. 73.2 months, p < 0.001), reflecting a shift in practice over time. We found no significant difference in local recurrence rate or functional outcome in patients treated with or without cryoablation. Formal curettage with additional high-speed burr drilling provides effective tumor control and favorable functional outcomes, negating the need for adjuvant cryoablation.

Favorable outcomes of navigated percutaneous ablation and cementoplasty of bone metastasis in the extremities and pelvis-a case series of 13 cases.

OBJECTIVES: Palliative treatment options for bone metastasis are limited, especially in cases where standard protocols have already failed. The purpose of this study was to evaluate the efficacy and safety of percutaneous ablation, either by cryoablation or radiofrequency, combined with percutaneous cementoplasty using cone-beam guided navigation. The objective was to relieve symptoms and improve functionality in patients suffering from pain secondary to bone metastases, as well as evaluate local disease progression post ablation. METHODS: We conducted a retrospective study of 13 patients (average age 63.6 ± 9.8, nine females) with symptomatic skeletal metastases treated using 3D imaging with navigation and followed for at least 12 months. The treatment protocol was implemented either after failure of first line treatment, or as first line when mechanical instability was present. Percutaneous lesion ablation was performed along with percutaneous cementation. RESULTS: In this study, we observed a statistically significant decrease in pain. The mean Visual Analog Scale pain score decreased from 7.1 ± 0.4 prior to CRA/RFA to 2.2 ± 0.3 after the procedure (p < 0.001). At the 12-months follow-up, all patients were able to ambulate with no assistance (Eastern Cooperative Oncology Group <2). One minor adverse event (paresthesia) and one major adverse event (drop foot) were resolved at 1 year of follow-up. CONCLUSIONS: Treatment of bone metastasis with RFA and CRA in conjunction with cementoplasty using Cone-beam computed tomography navigation provides patients with significant palliative outcomes and in most cases, local tumor control.

Internal Hemipelvectomy for primary bone sarcomas using intraoperative patient specific instruments- the next step in limb salvage concept.

BACKGROUND: During pelvic Sarcoma resections, Surgeons often struggle to obtain negative margins while minimizing collateral damage and maintaining limb function. These complications are usually due to the complex anatomy of the pelvis. Here we present an accurate 3D surgical approach, including pre-operative printing of models and intraoperative patient-specific instruments (PSIs) for optimizing pelvic sarcoma resections. METHODS: This single-center retrospective study (N = 11) presents surgical, functional, and oncological outcomes of patients (average age 14.6 +/- 7.6 years, 4 males) who underwent pelvic sarcoma resections using a 3D surgical approach between 2016 and 2021. All patients were followed up for at least 24 months (mean = 38.9 +/- 30.1 months). RESULTS: Our results show promising surgical, oncological, and functional outcomes. Using a 3D approach, 90.9% had negative margins, and 63.6% did not require reconstruction surgery. The average estimated blood loss was 895.45 ± 540.12 cc, and the average surgery time was 3:38 ± 0.05 hours. Our results revealed no long-term complications. Three patients suffered from short-term complications of superficial wound infections. At 24 month follow up 72.7% of patients displayed no evidence of disease. The average Musculoskeletal Tumor Society (MSTS) score at 12 months was 22.81. CONCLUSION: 3D technology enables improved accuracy in tumor resections, allowing for less invasive procedures and tailored reconstruction surgeries, potentially leading to better outcomes in function and morbidity. We believe that this approach will enhance treatments and ease prognosis for patients diagnosed with pelvic sarcoma and will become the standard of care in the future.

Three dimensional printing as an aid for pre-operative planning in complex cases of total joint arthroplasty: A case series.

Purpose: Digital templating is an essential aspect of pre-operative planning for total joint arthroplasty procedures. For complex cases of joint reconstruction, the standard templating software is insufficient to achieve the desired accuracy. 3D printing significantly aids the pre-operative planning in complicated cases of joint reconstruction and offers immense potential towards improving outcomes in these cases. The purpose of the present study is to present the various ways in which 3D printing has aided our department in facilitating complex cases of lower extremity reconstruction. Methods: Data was retrospectively retrieved for all patients that underwent total hip arthroplasty (THA) and total knee arthroplasty (TKA) with the aid of 3D printing technology at our institution between January 2016-February 2021. Patient pain was determined before and after surgery using the visual analogue scale (VAS). Patient reported outcome measures (PROMs) were additionally analyzed using the hip disability and osteoarthritis outcome score (HOOS) and knee injury and osteoarthritis outcome score (KOOS). Results: The final study population consisted of 39 patients that underwent TKA or THA procedures with the use of 3D printing. Twenty-four (61.5%) of the surgeries in the study were THA procedures, whereas 15 (38.5%) were TKA procedures. The average VAS for patients reduced from 8.4% before surgery to 5.4% after surgery (p < 0.001). The mean KOOS of patients that underwent TKA was 17.33 ± 9.33 (43%) and the mean HOOS of patients that underwent THA was 13.79 ± 6.6 (42%). Conclusions: The following series demonstrates the ability by which 3D printing facilitates complex cases of hip and knee reconstruction. 3D printing offers an improvement in understanding of patient specific anatomy, enhancing patient outcomes. Departments should consider the use of 3D printing technology as an adjunct when performing complex cases of lower extremity reconstruction.

Intercalary and geographic lower limb tumor resections with the use of 3D printed Patient Specific Instruments- when less is more.

Background: Primary bone sarcomas are associated with critically sized bone defects and require complete resection with negative margins. Recent advancements in health care have pioneered novel approaches such as the implementation of 3D surgical technologies. This study presents oncological and functional outcomes following tumor resections of long bones with the use of customized 3D-printed Patient Specific Instruments (PSIs). Methods: This single-center retrospective study is comprised of seventeen patients who underwent either intercalary (N = 12) or geographic (N = 5) resections with various reconstruction methods including allograft (N = 8), vascularized fibula (Capanna) (N = 7), and 3D printed customized titanium implants (N = 2), between the years 2016-2020. All patients were operated on with a 3D surgical workflow, including intraoperative PSIs, and were followed up postoperatively for at least 12 months (average 31.40 ± 12.13 months) to assess oncological and functional outcomes. Results: All patients demonstrated negative surgical margins, apart from one patient who had planned positive margins. Three patients suffered from short-term complications, and three patients underwent revision surgery due to graft non-union or pathological fracture. One patient suffered from local recurrence and underwent above-knee amputation. Three patients suffered from lung metastasis. MSTS at 12-month follow-up was 26.9.±5.87. Conclusion: Customized 3D-printed osteotomy PSIs provide surgeons with a novel tool for optimizing bone resection and reconstruction in long bones surgeries, thus minimizing overall tissue trauma and reducing the risk of damage to nervous and vascular structures. This study demonstrates that the use of PSIs has the potential to improve functional and oncological outcomes. We believe that this technique will become increasingly popular in the future as a widely applicable, highly accurate, cost-effective optimization tool.

Hepatitis C is an Independent Risk Factor for Perioperative Complications and Nonroutine Discharge in Patients Treated Surgically for Hip Fractures.

OBJECTIVE: To evaluate the relationship between noncirrhotic hepatitis C virus (HCV) infection, perioperative complications, and discharge status in patients undergoing surgical procedures for hip fractures. METHODS: A retrospective epidemiological study was performed, querying the National Hospital Discharge Survey. Patients were selected using the International Classification of Diseases-9 diagnostic codes for hip fracture and primary procedural codes for open reduction internal fixation, hemiarthroplasty, total hip arthroplasty, or internal fixation. Patients with concurrent cirrhosis, HIV, hepatitis A, B, D, or E were excluded. Pearson χ tests, independent-samples t test, and multivariable binary logistic regression were used for data analysis. RESULTS: Two cohorts surgically treated for a hip fracture were identified and compared. The first cohort included 5377 patients with a concurrent diagnosis of noncirrhotic HCV infection (HCV+) and the second included 4,712,159 patients without a diagnosis of HCV (HCV-). The HCV+ cohort was younger and had fewer medical comorbidities, yet was found to have a longer length of hospital stay, higher rates of nonroutine discharge, and higher rates of complications than the HCV- cohort. Multivariate regression analysis demonstrated that HCV+ is an independent risk factor for perioperative complications and nonroutine discharge. CONCLUSIONS: In conclusion, our study demonstrates a negative association between noncirrhotic HCV infection and hip fracture surgery outcomes. Caution and appropriate preparation should be taken when surgically treating hip fractures in HCV+ patients because of higher risk of perioperative complications and nonroutine discharge. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Anxiolytic medication as an adjunct to morphine analgesia for acute low back pain management in the emergency department: a prospective randomized trial.

STUDY DESIGN: Prospective, single-blinded, and randomized clinical trial. OBJECTIVE: This study evaluates the added benefit of promethazine administration as an anxiolytic adjunct to morphine analgesia in reducing acute low back pain (LBP) compared with morphine alone. SUMMARY OF BACKGROUND DATA: Acute LBP is one of the most common reasons for emergency department (ED) visits. The optimal analgesic treatment for acute LBP remains controversial. Anxiety relief has been shown to improve pain management in the ED setting. We hypothesized that administration of the antihistamine promethazine as an anxiolytic adjunct to morphine analgesia will improve LBP management compared with morphine alone. METHODS: Fifty-nine adults, who were treated in our ED for severe acute LBP (visual analogue scale ≥ 70 mm), were randomly enrolled in the study. Thirty patients received slow infusion of intravenous (IV) morphine 0.1 mg/kg in normal saline and 29 patients received an analgesic regimen of IV morphine 0.1 mg/kg with promethazine 25 mg administered similarly. Pain and anxiety levels were subjectively assessed by the patients on a 100-mm visual analogue scale before and after treatment. Adverse event related to analgesia were recorded in real time. RESULTS: After analgesia administration patients' pain rating decreased by 43 mm in the morphine group and by 39 mm in the morphine/promethazine group (P = 0.26). Similarly, patients' anxiety decreased by 19 mm in the morphine group and by 13 mm in the morphine/promethazine group (P = 0.37). The average ED stay was 78 minutes longer in the morphine/promethazine group (P = 0.01), due to the strong sedative effect of promethazine. Patients' satisfaction and the rate of adverse events were similar in both groups. CONCLUSION: IV administration of morphine-promethazine regimen for pain and anxiety relief associated with acute LBP showed no advantage compared with IV morphine alone and significantly lengthened the overall ED stay. Thus, we think that promethazine has no place in acute LBP management in the adult ED setting. LEVEL OF EVIDENCE: 1.