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BACKGROUND: Pseudotumor formation is a well-known complication in metal-on-metal (MoM) THA. Pseudotumors combined with elevated serum ion levels and complaints from patients can lead to high revision rates. Long-term (> 10 years) results obtained from randomized trials comparing large-head MoM THA and conventional metal-on-polyethylene (MoP) THA are lacking regarding revision and survival rates, pseudotumor formation, functional outcomes, and serum ion levels.
OBJECTIVE: At 10 years of follow-up, (1) what is the difference in survival and revision rates between large-head (38 to 60 mm) MoM THA and conventional 28-mm MoP THA? (2) What is the difference in pseudotumor formation between large-head MoM THA and MoP THA? (3) Is there a difference in functional outcome between large-head MoM THA and MoP THA? (4) What is the difference in serum ion levels between large-head MoM THA and MoP THA?
METHODS: Between January 2006 and December 2008, 104 patients were randomized to receive either cementless MoM THA (50 patients) or cementless MoP THA (54 patients). In all, 78% (81 of 104) of patients completed the 10-year postoperative follow-up: 36 patients with MoM THA (72%; six patients lost to follow-up) and 45 with MoP THA (83%; four lost to follow-up). In the MoM group, 47% (17) were men, and the patients had a mean ± SD age of 60 ± 5 years. In the MoP group, 38% (17) were men, and the patients had a mean age of 61 ± 5 years. All baseline characteristics were similar between the groups. At 10 years of follow-up, all patient records were screened for revision surgery or complications, and the primary endpoint was survivorship free from revision for any cause at the 10-year follow-up interval, which we analyzed using a Kaplan-Meier survival analysis. All patients had a CT scan to determine the pseudotumor classification, which was reviewed by an independent radiologist. Functional outcome was measured using the patient-reported Oxford Hip Score and Harris Hip Score; the latter was assessed by a blinded nurse practitioner. Finally, serum ion cobalt and chrome concentrations were measured at 10 years postoperatively. Because the a priori sample size calculation for this randomized controlled trial was based on a different endpoint, a post hoc power analysis was performed for this long-term follow-up study, with survival as the primary outcome. It showed that considering the number of included patients, this study would have sufficient power (one-sided testing, alpha 0.05, power 80%) to discern a difference of 20% in the survival rate between the MoP and MoM groups (95% versus 75%).
RESULTS: With the numbers available, there was no difference in survivorship free from revision for any cause between the MoP group and MoM group at 10 years (95% [95% CI 85% to 98%] versus 92% [95% CI 82% to 98%]; p = 0.6). A higher percentage of patients in the MoM group had pseudotumors on CT than those in the MoP group did, but pseudotumors were observed in both groups (56% [20 of 36] in the MoM group versus 22% [10 of 45] in the MoP group, relative risk 1.8 [95% CI 1.2 to 2.6]; p = 0.002). A higher proportion of elevated cobalt and chrome levels was found in the MoM group (19% and 14%, respectively) than in the MoP group (0% for both cobalt and chrome) (cobalt: RR 1.2 [95% CI 1.1 to 1.5]; p = 0.002; chrome: RR 1.2 [95% CI 1.0 to 1.3]; p = 0.01). In 25% of the patients with pseudotumors (5 of 20 patients), there were elevated serum cobalt levels. None of the 23 patients without pseudotumors had elevated cobalt levels (RR 1.3 [95% CI 1.0 to 1.7]; p = 0.01). There was no difference in functional outcome between study groups, nor a difference between patients with a pseudotumor and those without.
CONCLUSIONS: This study showed that the survival of patients with large-head MoM THA was high and comparable to that of those with MoP THA, which contrasts with the high revision rates reported by others. Although some patients with MoP THAs experienced pseudotumors, the risk of a pseudotumor was much greater in MoM hips, and serum ion levels were higher in patients who received an MoM THA. For these reasons and unknown future complications, continued surveillance of patients with MoM THAs seems important.
METHODS: Level I, therapeutic study.

BACKGROUND: Metal allergy remains a controversial topic in the orthopaedic community. It is not known if or to what degree metal sensitivity contributes to inflammatory soft tissue failures, unexplained residual pain, or clinical complications after total joint replacement with metal prostheses.
METHODS: We investigated the efficacy of the lymphocyte transformation test (LTT) in predicting adverse outcomes in patients after receiving a metal joint replacement. Our study cohort consists of 135 metal-on-metal hip resurfacing arthroplasty cases performed between 2013 and 2015. All study patients had an LTT preoperatively. We retrospectively analyzed clinical outcomes and failures for our cohort.
RESULTS: There was no difference in LTT reactivity between men and women. Of the 135 patients tested, 46 (34.1% of cohort) tested positive to at least one of the materials comprising their implant, and 78 patients (57.8%) had at least one reactive score to any component of the LTT. After a minimum follow-up of two years, we did not observe an allergic response to the implant in any patients. There were no failures requiring revision. We observed a 2.2% rate of moderate residual pain; no patients with residual pain tested positive for metal sensitivity. When patients with moderate-high LTT reactivity (30.4% of cohort) were compared to the remainder of the study group, there was no difference in HHS or UCLA activity score. There was no correlation between blood metal ion levels and LTT reactivity.
CONCLUSIONS: We were unable to prove any predictive value of the LTT. We failed to identify hypersensitivity to metals in patients with metal-on-metal hip resurfacing arthroplasty.

Aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) are typically described in the context of metal-on-metal (MoM) hip bearings. This study explores the diagnostic utility of preoperative serum cobalt and chromium ion levels in determining the histological grade of ALVAL in revision hip and knee arthroplasty.
This was a multicenter retrospective review of 26 hips and 13 knees assessing the correlation between preoperative ion levels (mg/L (ppb)) and the histological grade of ALVAL from intraoperative specimens. The diagnostic ability of preoperative serum cobalt and chromium levels to determine high-grade ALVAL was assessed using a receiver operating characteristic (ROC) curve.
In the knee cohort, there was a higher serum cobalt level in high-grade ALVAL cases (10.2 mg/L (ppb) versus 3.1 mg/L (ppb)) (P = .0002). The Area Under the Curve (AUC) was 1.00 (95% confidence interval (CI) 1.00 to 1.00). There was a higher serum chromium level in high-grade ALVAL cases (12.25 mg/L (ppb) versus 7.77 mg/L (ppb)) (P = .0002). The AUC was 0.806 (95% CI 0.555 to 1.00). In the hip cohort, there was a higher serum cobalt level in high-grade ALVAL cases (333.5 mg/L (ppb) versus 119.9 mg/L (ppb)) (P = .0831). The AUC was 0.619 (95% CI 0.388 to 0.849). There was a higher serum chromium level in high-grade ALVAL cases (186.4 mg/L (ppb) versus 79.3 mg/L (ppb)) (P = .183). The AUC was 0.595 (95% CI 0.365 to 0.824).
Histologically, high-grade ALVAL has significantly higher preoperative serum cobalt and chromium ion levels in revision TKA. Preoperative serum ion levels have excellent diagnostic utility in revision TKA. Cobalt levels in revision THA have a fair diagnostic ability and chromium levels had a poor diagnostic ability.

BACKGROUND: Pseudotumors and muscle atrophy have been associated with metal-on-metal (MoM) resurfacing hip arthroplasty (RHA). We aimed to investigate the influence of the anterolateral (AntLat) and the posterior (Post) surgical approach on the location, grade and prevalence of pseudotumors and muscle atrophy in MoM RHA.
METHODS: Forty-nine patients were randomized to MoM RHA by the AntLat (n = 25) or the Post (n = 24) approach at Aarhus University Hospital. Patients underwent metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) scans for investigation of location, grade and prevalence of pseudotumors and muscle atrophy. Plain radiographs, metal-ions concentrations and clinical outcome scores were evaluated to compare outcomes of the surgical approaches.
RESULTS: MRI-detected pseudotumors were seen in 7 of 18 patients (39%) in the AntLat group and in 12 of 22 patients (55%) in the Post group (p = 0.33). Pseudotumors were mainly located anterolaterally to the hip joint in the AntLat group and postero-lateral to the hip joint in the Post group. Higher grades of muscle atrophy of the caudal part of the gluteus medius and minimus (p < 0.004) were seen in the AntLat group, and higher grades of muscle atrophy of the small external rotators were seen in the Post group (p < 0.001). The AntLat group had higher anteversion angles of mean 15.3° (range 6.1-7.5) versus mean 11.5° (range 4.9-22.5) in the Post group (p = 0.02). Metal-ion concentrations and clinical outcome scores were similar between groups (p > 0.08).
CONCLUSIONS: Muscle atrophy and pseudotumor location after MoM RHA follow the surgical approach used for implantation. This knowledge may help differentiate between \"normal postoperative appearance\" and \"MoM disease.\"

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OBJECTIVE: To investigate the long-term survivorship, incidence of adverse reactions to metal debris (ARMD), and metal ion behavior in patients who underwent small-head Metasul metal-on-metal (MoM) total hip arthroplasty (THA).
METHODS: Between February 1998 and September 2003, a retrospective study was performed on 43 consecutive patients (43 hips) who underwent unilateral cementless Metasul MoM THAs at our institution. Of them, 35 patients (nine males and 26 females) who were available for follow-up more than 15 years after THA were enrolled in this study and underwent metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) to identify ARMD. The mean age at surgery of the patients was 59.7 years old (range, 31-83). Clinical and radiographic outcomes were evaluated retrospectively. Clinical examinations were conducted using the Harris Hip Score (HHS). Serum cobalt (Co) and chromium (Cr) ion levels and Co/Cr ratio were assessed at different postoperative periods of <5, 5-10, 11-14, and ≥15 years.
RESULTS: The mean follow-up period for the 35 patients included was 18.1 years (range, 15-22). The mean HHS significantly improved from 44.6 ± 11.3 points preoperatively to 89.4 ± 7.9 points at the final follow-up (P < 0.0001). ARMD was found in 20% of the patients using MARS-MRI. No signs of stem loosening were found clinically or radiographically, whereas cup loosening and ARMD were observed in three patients (9%), for whom revision THAs were performed. The Kaplan-Meier survival rates with revision for any reason as the endpoint were 90.9% at 5 years, 84.8% at 10 years, 84.8% at 15 years (95% CI, 67.1-93.6), and 70.3% at 20 years (95% CI, 43.6-87.0). The survival rates with revision for ARMD as the endpoint were 100% at 5 years, 96.6% at 10 years, 96.6% at 15 years (95% CI, 77.2-99.7), and 80.1% at 20 years (95% CI, 45.3-95.2). Serum Co ion level peaked at 5-10 years after THA, which was significantly higher than that <5 years; however, it decreased to the initial level after 15 years. In contrast, serum Cr ion level significantly increased at 5-10 years and then remained almost constant. Significant differences in Cr ion levels (1.0 vs 2.0 μg/L, P = 0.024) and Co/Cr ratio (1.3 vs 0.9, P = 0.037) were found between non-ARMD and ARMD patients at >11 years postoperatively.
CONCLUSIONS: Our results suggest that increased Cr ion levels and decreased Co/Cr ratio may be signs of ARMD in patients who underwent small-head Metasul MoM THA.

BACKGROUND: The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the twenty-first century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions. The purpose was to compare Harris Hip Score and SF-36 at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM hip resurfacing (MoM-HR).
METHODS: The study was conducted between November 2006 to January 2012 in a tertiary health care center in Denmark. Patients with primary or secondary osteoarthritis were randomly assigned to receive a Magnum (MoM-LDH-THA) or a Recap (MoM-HR) prosthesis. Randomization was computer generated and allocation was concealed in an opaque envelope. Neither patients nor care provider were blinded. Primary outcome was Harris Hip Score at 5-years follow up.
RESULTS: Seventy-five were included and allocated to the MoM-LDH-THA (n = 39) and MoM-HR (n = 36) group. The study was prematurely stopped due to numerous reports of adverse events in patients with MoM hip replacements. Thirty-three in the MoM-LDH-THA and 25 in the MoM-HR group were available for primary outcome analysis. Median Harris Hip Score was 100 (IQR: 98-100) for MoM-LDH-THA and 100 (IQR: 93-100) for MoM-HR (p = 0.486). SF-36 score was high in both groups with no significant difference between groups.
CONCLUSIONS: Harris Hip Score and SF-36 score was excellent in both groups with no significant difference at 5-years follow up. Our findings suggest that there is no clinical important difference between the two prostheses implanted 5 years after implantation.
BACKGROUND: ClinicalTrials.gov, NCT04585022 , Registered 23 September 2020 - Retrospectively registered. This study was not prospectively registered in a clinical trial database since it was not an entirely implemented standard procedure in the international orthopedic society when the study was planned.

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