Factors Associated With Nonunion in Arthrodesis of the First Metatarsophalangeal Joint: A Multicenter Retrospective Cohort Study.

BACKGROUND: Arthrodesis of the first metatarsophalangeal joint is the current treatment of choice for symptomatic advanced hallux rigidus and moderate-to-severe hallux valgus. There are different methods to perform arthrodesis, yet no consensus on the best approach. Therefore, this study aimed to determine the effects of preoperative and postoperative hallux valgus angle (HVA), joint preparation and fixation technique, and postoperative immobilization on the incidence of nonunion. METHODS: A retrospective multicenter cohort study was performed that included 794 patients. Univariate and multiple logistic regression was conducted to determine associations between joint preparation, fixation techniques, postoperative immobilization, weightbearing, and pre- and postoperative HVA with nonunion. RESULTS: Nonunion incidence was 15.2%, with 11.1% symptomatic and revised. Joint preparation using hand instruments (OR 3.75, CI 1.90-7.42) and convex/concave reamers (OR 2.80, CI 1.52-5.16) were associated with greater odds of a nonunion compared to planar cuts. Joint fixation with crossed screws was associated with greater odds of nonunion (OR 2.00, CI 1.11-3.42), as was greater preoperative HVA (OR 1.02, CI 1.00-1.03). However, the latter effect disappeared after inclusion of postoperative HVA in the model, with a small association identified between residual postoperative HVA and nonunion (OR 1.04, CI 1.01-1.08). Similarly, we found an association between odds of nonunion and higher body weight (OR 1.02, CI 1.01-1.04) but not of body mass index. CONCLUSION: Based on our results, first metatarsophalangeal joint arthrodesis with planar cuts and fixation with a plate and interfragmentary screw is associated with the lowest odds of resulting in a nonunion. Higher body weight and greater preoperative HVA were associated with slight increase in rates of nonunion. It is crucial to properly correct the hallux valgus deformity during surgery. LEVEL OF EVIDENCE: Level III, retrospective case control study.

Ten-year results of a prospective cohort of large-head metal-on-metal total hip arthroplasty : a concise follow-up of a previous report.

AIMS: Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels. METHODS: All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (x-ray and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up. RESULTS: Mean follow-up was 10.9 years (10 to 12), with a cumulative survival rate of 82.4%. Reason for revision was predominantly pseudotumour formation (68%), apart from loosening, pain, infection, and osteolysis. The prevalence of pseudotumour formation around the prostheses was 41%, while our previous report of this cohort (with a mean follow-up of 3.6 years) revealed a 39% prevalence. The ten-year revision-free survival with pseudotumour was 66.7% and without pseudotumour 92.4% (p < 0.05). There was poor discriminatory ability for cobalt for pseudotumour formation. CONCLUSION: This prospective study reports a minimum ten-year follow-up of large-head MoM THA. Revision rates are high, with the main reason being the sequelae of pseudotumour formation, which were rarely observed after five years of implantation. Blood ion measurements show limited discriminatory capacity in diagnosing pseudotumour formation. Our results evidence that an early comprehensive follow-up strategy is essential for MoM THA to promptly identify and manage early complications and revise on time. After ten years follow-up, we do not recommend continuing routine CT scanning or whole cobalt blood measurements, but instead enrolling these patients in routine follow-up protocols for THA. Cite this article: Bone Jt Open 2022;3(1):61-67.

Effectiveness of rehabilitation after a total hip arthroplasty: a protocol for an observational study for the comparison of usual care in the Netherlands versus Germany.

INTRODUCTION: Osteoarthritis is the most common joint disorder worldwide. Total hip arthroplasty (THA) is considered one of the most effective treatments for end-stage hip osteoarthritis. The number of THAs is expected to increase dramatically in the coming decades. Usual postoperative rehabilitation after primary THA differs between the German and the Dutch system. In the Netherlands, patients undergo fast-track surgery and are discharged into their home environment within a few days without receiving any aftercare. In Germany, patients stay in the hospital for about 12 days before being transferred to a rehabilitation centre for a period of 3 weeks. The superficially more cost-effective Dutch system of usual care after THA is judged critically in both countries due to suboptimal rehabilitation outcomes. The aim of this study is therefore to compare the Dutch with the German usual care rehabilitation after primary THA. It is hypothesised that the German procedure is more effective in terms of functional outcomes and patient satisfaction than the Dutch procedure and that in the long run the German approach is more cost-effective than the Dutch system. METHODS AND ANALYSIS: Medical effectiveness will be assessed at four different time points by means of patient self-reported questionnaires and functional tests. Assessments include the Hip disability and Osteoarthritis Outcome Score, Patient Acceptable Symptom State, Short Form 36, EuroQol 5 Dimensions 3 Level Questionnaire, Timed Up & Go Test and Five Times Sit-to-Stand Test. Additionally, long-term economic aspects in both countries will be assessed from a societal perspective, to get a first impression on whether cutting costs for rehabilitation, as practised in the Netherlands, really disburdens the healthcare system efficiently. ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards of both University Medical Center Groningen (METc2015/483) and Hannover Medical School (no 2874-2015) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013). The results of the study will be published in international peer-reviewed scientific journals. Patient data will be presented anonymously in any publication or scientific journal. TRIAL REGISTRATION NUMBER: DRKS00011345; Pre-results.

Sequelae of large-head metal-on-metal hip arthroplasties: Current status and future prospects.

Large-head metal-on-metal (MoM) bearings were re-popularised in the late 1990s with the introduction of modern hip resurfacing (HR), followed closely by large metal head total hip arthroplasty (THA). A worldwide increase in the use of MoM hip arthroplasty subsequently saw a sharp decline, due to serious complications.MoM was rapidly adopted in the early 2000s until medical device alerts were issued by government regulatory agencies and national and international organisations, leading to post-marketing surveillance and discontinuation of these implants.Guidelines for MoM hip implant follow-up differ considerably between regulatory authorities worldwide; this can in part be attributed to missing or conflicting evidence.The authors consider that the use of large-head MoM THA should be discontinued. MoM HR should be approached with caution and, when considered, should be used only in patients who meet all of the recommended selection criteria, which limits its indications considerably.The phased introduction of new prostheses should be mandatory in future. Close monitoring of outcomes and long-term follow-up is also necessary for the introduction of new prostheses. Cite this article: van Lingen CP, Zagra LM, Ettema HB, Verheyen CC. Sequelae of large-head metal-on-metal hip arthroplasties: current status and future prospects. EFORT Open Rev 2016;1:345-353. DOI: 10.1302/2058-5241.1.160014.

Development and first validation of a simplified CT-based classification system of soft tissue changes in large-head metal-on-metal total hip replacement: intra- and interrater reliability and association with revision rates in a uniform cohort of 664 arthroplasties.

OBJECTIVE: After implantation of a metal-on-metal total hip arthroplasty (MoM THA), a large incidence of pseudotumor formation has been described recently. Several centers have invited patients for follow-up in order to screen for pseudotumor formation. The spectrum of abnormalities found by CT in MoM THA patients can be unfamiliar to radiologists and orthopedic surgeons. Previously, a CT five-point grading scale has been published. In this paper, a simplification into a three-point classification system gives insight in the morphological distinction of abnormalities of the postoperative hip capsule in MoM implants in relation to the decision for revision. The reliability of this simplified classification regarding intra- and interrater reliability and its association with revision rate is investigated and discussed. MATERIALS AND METHODS: All patients who underwent MoM THA in our hospital were invited for screening. Various clinical measures and CT scan were obtained in a cross-sectional fashion. A decision on revision surgery was made shortly after screening. CT scans were read in 582 patients, of which 82 patients were treated bilaterally. CT scans were independently single read by two board-certified radiologists and classified into categories I-V. In a second meeting, consensus was obtained. Categories were subsequently rubricated in class A (categories I and II), B (category III), and C (categories IV and V). Intra- and inter-radiologist agreement on MoM pathology was assessed by means of the weighted Cohen's kappa. Categorical data were presented as n (%), and tested by means of Fisher's exact test. Continuous data were presented as median (min-max) and tested by means of Mann-Whitney U test (two group comparison) or Kruskal-Wallis test (three group comparison). Logistic regression analysis was performed in order to study independence of CT class for association with revision surgery. Univariate statistically significant variables were entered in a multiple model. All statistical analysis was performed two-tailed using alpha 5% as the significance level. RESULTS: In total, 664 scores from 664 MoM hips obtained by two observers were available for analyses. Interobserver reliability for the non-simplified version (I-V) was κw = 0.71 (95% CI: 0.62-0.79), which indicates good agreement between the two musculoskeletal radiologists. Intra- and interobserver reliability for the simplified version (A-C) were respectively κw 0.78 (95% CI: 0.68-0.87), and κw = 0.71 (95% CI: 0.65-0.76). This indicates good agreement within and between the two observers. The simplified A-C version is significantly associated with revision exclusively due to MoM pathology, in both patients with unilateral MoM THA (p < 0.001) and patients with bilateral MoM THA (p < 0.044). The simplified A-C version is associated with several clinical measures. In patients with unilateral MoM THA, with or without contralateral THA, in situ time (p < 0.008), cobalt and chromium (p < 0.001) were statistically significant. In patients with bilateral MoM, cobalt (p < 0.001) and chromium (p < 0.027) were statistically significant. Revision is significantly associated with cup size (p < 0.001), anteversion of the cup (p < 0.004), serum ion levels of cobalt and chromium (p < 0.001) and the adapted classification system (p < 0.001). In univariate logistic regression analysis on revision, cup, anteversion of the cup, cobalt-chromium ion serum levels, and the simplified (A-C) CT category system were statistically significant. The simplified (A-C) CT category system was an independent associate of revision, in several multiple logistic regression models. CONCLUSIONS: The presented simplified CT grading system (A-C) in its first clinical validation on 48- and 64-multislice systems is reliable, showing good intra- and interrater reliability and is independently associated with revision surgery.

Revision of a single type of large metal head metal-on-metal hip prosthesis.

Large-head metal-on-metal (MoM) total hip arthroplasties were introduced because of their purported advantages. Inflammatory pseudotumours occasionally occur after MoM hip arthroplasty and often lead to revision. The purpose of this study was to assess the outcome of revision of large-head MoM total hip arthroplasties after an extensive screening protocol for all MoM articulations with a minimum 2 year follow-up. We identified 50 hips that had undergone large-head MoM total hip arthoplasty and required revision at a mean of 44 months after index operation. Of these, 38 were revised for pseudotumours, 7 for loosening, 2 for infection and 3 for instability. There was bone loss in 44 hips. The majority were revised to a 28 mm metal or ceramic head on a polyethylene-cemented cup. In 12 patients there was a complication. There was a decrease of whole blood cobalt from 20.8 µg/L preoperatively to 1.8 µg/L 1 year after revision. We found 6 residual masses on routine postoperative CT scans. The indication for revision of this cohort is inevitable but the clinical outcome 2 years after revision for pseudotumour is disappointing. Revising a MoM hip arthroplasty to a conventional cemented polyethylene or dual-mobility cup with bone impaction grafting and a 28 mm head can adequately treat the high ion levels and probably the disease of ARMD.

Self-reported neurological clinical manifestations of metal toxicity in metal-on-metal hip arthroplasty.

Adverse reactions to metal particle debris have been increasingly reported as a complication following large head metal-on-metal (MoM) hip arthroplasty. Elevated metal ion levels are a cause for concern. The aim of this study is to evaluate whether exposure to cobalt is associated with patient characteristics and symptoms of neuropathy, representing nervous system dysfunction. A cross-sectional study was conducted comparing patients with a MoM total hip arthroplasty and patients with a conventional hip arthroplasty. They received three questionnaires, one to assess neurotoxic complaints and two standardised self-administered questionnaires to identify symptoms that are suggestive of peripheral neuropathy. Current and historical data were available for whole blood cobalt levels in all patients. We analysed potential predictive factors for cobalt based on five different cut-off levels (0-2, 2-4, 4-10, 10-20, >20 µg/L). We performed 723 MoM total hip arthroplasties in 643 patients in our clinic. The response rate was 89%. Male-female ratio was 236/280, median age 63.6 years (30-72) with a mean follow-up of 50.6 months (20-86). We also sent the questionnaires to 98 patients in the control group. An increase in the incidence of reported symptoms was not consistent with higher serum cobalt levels. Female gender was the only consistent predictive factor for serum cobalt at different cobalt cut-off levels in the multivariate analysis. The study population did not show an increase in reported symptoms with elevated cobalt levels. Neurotoxic symptoms and whole blood cobalt levels did not show a consistent relationship with different dichotomised levels of cobalt exposure.

Clinical manifestations in ten patients with asymptomatic metal-on-metal hip arthroplasty with very high cobalt levels.

Reports of adverse reactions to metal particle debris with metal-on-metal (MoM) hip arthroplasty have increased recently. Apart from the formation of pseudotumours and higher revision rates, another major cause for concern are the systemic effects of metal ions. Several effects of elevated systemic cobalt ions have been reported (e.g., myocardial and neurological effects, hypothyroidism). All 643 patients who underwent a stemmed large head MoM total hip replacement in our clinic were screened with repeated whole blood samples of metal ions (cobalt, chromium). We included ten asymptomatic unrevised patients with the highest cobalt concentrations, determined at a minimum of three years after implantation. These patients were subjected to an extensive neurological and cardiological screening protocol. In addition, blood samples were taken to assess renal and thyroid function. Ten patients with a cobalt level of 18-153 µg/L (mean 46.8 µg/L) were included. Nine patients were female, mean age was 65 years (range 56-75). The mean follow-up period was 4.2 years (range 3.0-6.1). Seven patients had bilateral stemmed MoM hip arthroplasty. No signs or symptoms of neurological dysfunction, cardiomyopathy, or renal or thyroid dysfunction could be identified or attributed to elevated cobalt levels. The clinical relevance of this study is that after short-term follow-up highly elevated blood cobalt levels do not cause systemic effects in our population. Hence in asymptomatic patients metal ions appear not to be a significant factor in the decision of when to revise a MoM large head total hip replacement.

Local recurrence of rectal cancer after total mesorectal excision without preoperative radiotherapy.

BACKGROUND: At this moment, it is still debatable whether all patients with mobile rectal cancer who undergo surgical removal of the tumor should be treated with preoperative radiotherapy, since it is likely that only certain patients will benefit from this strategy. In this study, patients with mobile rectal cancer were immediately operated upon and only those with positive nodes or with incomplete resection received adjuvant radiotherapy. AIMS OF THE STUDY: To investigate the local recurrence rate after the use of a selective policy of adjuvant radiotherapy and to determine risk factors for local recurrence. METHODS: In a 5-yr-period, 178 patients with rectal cancer were referred to our institute. A total of 131 patients with mobile rectal cancer were treated with curative intent, which implied a microscopically radical resection and no signs of distant metastasis at operation. A retrospective analysis was undertaken to investigate the incidence of local recurrence in this curative group and to determine risk factors for local recurrence. RESULTS: The postoperative mortality in the curative group was 5.3%. Local recurrences were observed in 6 patients (4.6%) after a median period of 25 mo (range 11-37); two of them also had distant metastases detected at the same time. The highest local recurrence rates were seen in men (5.3%), in distal rectal cancers (6.9%), and in the node-positive group (8.7%). CONCLUSION: A low local recurrence rate can be achieved after total mesorectal excision (TME) without preoperative radiotherapy. Our results suggest using preoperative radiotherapy only for those patients who are at a higher risk for local recurrence. Staging techniques for selection of these patients are at this moments till inappropriate.