Ceramic-on-Ceramic Total Hip Arthroplasty and Noises: A Prospective Blinded Randomized Controlled Trial of Influence of Component Design.

BACKGROUND: Noises have been associated with ceramic-on-ceramic bearings in total hip arthroplasties. The etiology is multifactorial, but a high prevalence of noises was reported in studies using a specific acetabular component system. We examined if specific ceramic component designs are associated with the prevalence of noises in 2 commonly used component systems. We hypothesized that there would be no difference in noises between the 2 systems. METHODS: In this randomized controlled trial, 2 different component designs with ceramic bearings were compared. Inclusion criteria were primary total hip arthroplasties, age between 18 and 65 years, and body mass index less than 35. The primary outcome was prevalence of noises, whereas secondary outcomes consisted of European Quality of Life index, visual analog scale, and University of California and Los Angeles activity scale. Follow-up data were collected at 3 and 12 months postoperatively. Data were available for 91 patients in Group 1 and for 92 patients in Group 2. Preoperative patient characteristics were comparable between groups. RESULTS: At 12-month follow-up, the prevalence of noises was 19% in Group 1 and 14% in Group 2 (P = .41). European Quality of Life index were 0.89 in Group 1 versus 0.90 in Group 2 (P = .42). The visual analog scale was 81 in both groups (P = .88). When evaluating level of activity, University of California and Los Angeles activity scale scores were 8.2 in both groups (P = .92). CONCLUSION: At 12-month follow-up, there was no difference in the prevalence of noises between the 2 component designs.

High-dose dexamethasone in low pain responders undergoing total knee arthroplasty: a randomised double-blind trial.

BACKGROUND: Postoperative pain after total knee arthroplasty (TKA) is a continuing problem despite optimised multimodal analgesia. Previous studies have shown preoperative glucocorticoids to reduce postoperative pain, but knowledge about specific doses and effects in specific patient groups is lacking. METHODS: A two-centre, double-blind, two-arm study comparing preoperative dexamethasone (1 mg kg-1vs 0.3 mg kg-1 i.v.) on postoperative pain in 160 planned TKA subjects with low preoperative pain catastrophising and no opioid use. Subjects received multimodal analgesia with paracetamol, cyclooxygenase-2 inhibitors, local anaesthetic infiltration analgesia, and rescue opioids. The primary outcome was percentage of subjects experiencing moderate to severe pain (visual analogue scale >30 mm) upon ambulation at 24 h. Secondary outcomes included pain scores, postoperative inflammation (C-reactive protein), opioid and antiemetics use, and 'Quality of Recovery-15' and 'Opioid-Related Symptom Distress Scale', length of stay, readmissions, and complications up to Day 90. RESULTS: A total of 157 subjects (80 vs 77) were included. No difference was found between groups in the incidence of subjects experiencing visual analogue scale >30 on ambulation 24 h after surgery (56% vs 53%, relative risk =1.07, confidence interval: 0.8-1.4, P=0.65). No differences in other pain outcomes or use of rescue opioids and antiemetics, in Quality of Recovery-15 and Opioid-Related Symptom Distress Scale, length of stay, readmissions, or complications. C-reactive protein values were comparable at 24 h (13 [6-25] mg L-1vs 16 [9-38] mg L-1, P = 0.07), but lower at 48 h (26 [9-52] mg L-1vs 50 [30-72] mg L-1, P<0.01) in the high-dose group. CONCLUSION: Use of 1 mg kg-1vs 0.3 mg kg-1 i.v. dexamethasone in low pain responders after TKA did not improve early postoperative pain or other outcomes in contrast to benefits in a high pain responder population. CLINICAL TRIAL REGISTRATION: NCT03758170 (first registration 29-11-2018).

High dose dexamethasone in high pain responders undergoing total hip arthroplasty: A randomized controlled trial.

BACKGROUND: Postoperative pain after total hip arthroplasty (THA) may delay postoperative mobilization and discharge. Postoperative pain has been shown to be higher in pain catastrophisers and patients receiving opioids. A single dose of glucocorticoid reduces pain after THA, and an increased dose of glucocorticoids has been found to be effective in patients at high risk of postoperative pain after total knee arthroplasty (TKA), however, the ideal dose in THA remains unknown. OBJECTIVE: To evaluate the effect of a high dose (1 mg kg -1 ) vs. intermediate dose (0.3 mg kg -1 ) of dexamethasone on pain after THA. DESIGN: A randomized double-blind controlled study. SETTING: A two-centre study including two large arthroplasty sites in Denmark was conducted from February 2019 to August 2020. PATIENTS: A total of 160 patients undergoing THA by neuraxial block with multimodal analgesia, having a Pain Catastrophising Scale score >20 and/or preoperative opioid use were included. INTERVENTION: Patients were randomly assigned to receive dexamethasone 1 mg kg -1 or 0.3 mg kg -1 before THA. MAIN OUTCOME MEASURES: Primary outcome was percentage of patients experiencing moderate to severe pain (visual analogue scale, VAS > 30 mm on a 0 to 100 mm scale) on ambulating 24 h after surgery. Secondary outcomes included cumulated pain scores, C-reactive protein (CRP), opioid use, postoperative recovery scores, length of stay, complications, and re-admission within 30 and 90 days. RESULTS: No difference was found in percentage of VAS >30 mm 24 h after surgery in the 5-m walk test (VAS > 30/VAS ≤ 30%); 33/42 (44%) vs. 32/43 (43%), relative risk = 1.04 (95% confidence interval 0.72-1.51; P  = 0.814) in 1 mg kg -1vs. 0.3 mg kg -1 respectively. No differences were found in CRP and opioid use between groups. Also, no intergroup differences were found in recovery scores, re-admissions, or complications. CONCLUSION: 1 mg kg -1vs. 0.3 mg kg -1 dexamethasone improved neither postoperative pain nor recovery in THA in a cohort of predicted high pain responders. TRIAL REGISTRATION: ClinicalTrials.gov ID-number NCT03763760 and EudraCT-number 2018-2636-25.

High-dose steroids in high pain responders undergoing total knee arthroplasty: a randomised double-blind trial.

BACKGROUND: Total knee arthroplasty (TKA) is associated with moderate-to-severe postoperative pain despite multimodal opioid-sparing analgesia. Pain catastrophising or preoperative opioid therapy is associated with increased postoperative pain. Preoperative glucocorticoid improves pain after TKA, but dose-finding studies and benefit in high pain responders are lacking. METHODS: A randomised double-blind controlled trial with preoperative high-dose intravenous dexamethasone 1 mg kg-1 or intermediate-dose dexamethasone 0.3 mg kg-1 in 88 patients undergoing TKA with preoperative pain catastrophising score >20 or regular opioid use was designed. The primary outcome was the proportion of patients experiencing moderate-to-severe pain (VAS >30) during a 5 m walk 24 h postoperatively. Secondary outcomes included pain at rest during nights and at passive leg raise, C-reactive protein, opioid use, quality of sleep, Quality of Recovery-15 and Opioid-Related Symptom Distress Scale, readmission, and complications. RESULTS: Moderate-to-severe pain when walking 24 h postoperatively was reduced (high dose vs intermediate dose, 49% vs 79%; P<0.01), along with pain at leg raise at 24 and 48 h (14% vs 29%, P=0.02 and 12% vs 31%, P=0.03, respectively). C-reactive protein was reduced in the high-dose group at both 24 and 48 h (both P<0.01). Quality of Recovery-15 was also improved (P<0.01). CONCLUSIONS: When compared with preoperative dexamethasone 0.3 mg kg-1 i.v., dexamethasone 1 mg kg-1 reduced moderate-to-severe pain 24 h after TKA and improved recovery in high pain responders without apparent side-effects. CLINICAL TRIAL REGISTRATION: NCT03763734.

Catabolic activity of osteoblast lineage cells contributes to osteoclastic bone resorption in vitro.

Osteoblast lineage cells in human bone were recently shown to colonize eroded bone surfaces and to closely interact with osteoclasts. They proved to be identical to reversal cells and are believed to differentiate into bone-forming osteoblasts thereby coupling resorption and formation. However, they also exert catabolic activity that contributes to osteoclastic bone resorption, but this has not received much attention. Herein, we used co-cultures of primary human osteoblast lineage cells and human osteoclasts derived from peripheral blood monocytes to investigate whether a catabolic activity of osteoblast lineage cells could impact on osteoclastic bone resorption. Through a combination of immunofluorescence, in situ hybridization and time-lapse experiments, we show that MMP-13-expressing osteoblast lineage cells are attracted to and closely interact with bone-resorbing osteoclasts. This close interaction results in a strong and significant increase in the bone resorptive activity of osteoclasts - especially those making trenches. Importantly, we show that osteoclastic bone resorption becomes sensitive to inhibition of matrix metalloproteinases in the presence, but not in the absence, of osteoblast lineage cells. We propose that this may be due to the direct action of osteoblast-lineage-derived MMP-13 on bone resorption.

Screening for retinopathy in children with type 1 diabetes in Denmark.

BACKGROUND/OBJECTIVE: Children with type 1 diabetes (T1D) are screened regularly for retinopathy with fundus photography to prevent visual impairment. According to Danish national guidelines, screening should take place at age 12, 15, and 18 years after minimum 3 years of diabetes. As glycemic control has improved, prevalence of retinopathy is expected to be decreased. The aim of this study is to investigate the prevalence, degree, and progression of retinopathy in children with T1D and to explore if screening at 12 years is currently indicated in Denmark. METHODS: Data on all Danish children with onset of T1D from 2003 to 2013 (n = 2943) were collected from the "DanDiabKids" registry. For children with registered screenings (n = 2382), prevalence of retinopathy at 12, 15, and 18 years was determined. In children with retinopathy, subsequent screenings were studied to reveal if retinopathy was persistent or temporary. RESULTS: Prevalence of retinopathy at 12, 15, and 18 years was 0.9%, 2.3%, and 3.1%, respectively. Minimal background retinopathy was seen in over 90% and 100% at 12 years. In available re-screenings, retinopathy resolved spontaneously in 87.5% of all cases and 100% of cases at 12 years. CONCLUSIONS: The prevalence of retinopathy in Danish children with T1D was low. At 12 years, prevalence was 0.9% and exclusively minimal background retinopathy with 100% remission in re-screenings. Thus, screening at this age does not seem to have significant clinical relevance. We propose more individualized screening selection before the age of 15.

Survival and revision causes of hip resurfacing arthroplasty and the Mitch proximal epiphyseal replacement: results from the Danish Hip Arthroplasty Register.

Background and purpose - The Mitch proximal epiphyseal replacement (PER) was developed to preserve proximal femoral bone and minimize femoral neck fracture associated with hip resurfacing arthroplasty (HRA). We studied the survival and risk of revision of HRA compared with cementless metal-on-polyethylene (MoP) total hip arthroplasty (THA) and the survival and risk of revision of the Mitch PER compared with MoP THA.Patients and methods - Using propensity score, we matched 1,057 HRA to 1,057 MoP THA and 202 Mitch PER to 1,010 MoP THA from the Danish Hip Arthroplasty Register. To estimate the relative risk (RR) of revision, we used regression with the pseudo-value approach and treated death as a competing risk.Results - The cumulative incidence for any revision of HRA at 10 years' follow-up was 11% (95% confidence interval [CI] 9.1-13) and 6.4% (CI 5.8-7.0) for MoP THA. The RR of any revision was 1.5 (CI 1.1-2.1) for HRA at 10 years' follow-up. By excluding the ASR components, the RR of revision at 10 years was 1.2 (CI 0.8-1.7). The cumulative incidence of revision was 9.6% (CI 4.2-18) for Mitch PER and 5.4% (CI 5.1-5.7) for MoP THA at 8 years. The RR of revision was 2.0 (CI 0.9-4.3) for Mitch PER at 8 years' follow-up.Interpretation - The HRA had increased risk of revision compared with the MoP THA. When excluding ASR, the HRA group had similar risk of revision compared with MoP THA. The Mitch PER did not have a statistically significant increased risk of revision compared with MoP THA.

Safety Aspects of Postanesthesia Care Unit Discharge without Motor Function Assessment after Spinal Anesthesia: A Randomized, Multicenter, Semiblinded, Noninferiority, Controlled Trial.

BACKGROUND: Postanesthesia care unit (PACU) discharge without observation of lower limb motor function after spinal anesthesia has been suggested to significantly reduce PACU stay and enhance resource optimization and early rehabilitation but without enough data to allow clinical recommendations. METHODS: A multicenter, semiblinded, noninferiority randomized controlled trial of discharge from the PACU with or without assessment of lower limb motor function after elective total hip or knee arthroplasty under spinal anesthesia was undertaken. The primary outcome was frequency of a successful fast-track course (length of stay 4 days or less and no 30-day readmission). Noninferiority would be declared if the odds ratio (OR) for a successful fast-track course was no worse for those patients receiving no motor function assessment versus those patients receiving motor function assessment by OR = 0.68. RESULTS: A total of 1,359 patients (98.8% follow-up) were available for analysis (93% American Society of Anesthesiologists class 1 to 2). The primary outcome occurred in 92.2% and 92.0%, corresponding to no motor function assessment being noninferior to motor function assessment with OR 0.97 (95% CI, 0.70 to 1.35). Adverse events in the ward during the first 24 h occurred in 5.8% versus 7.4% with or without motor function assessment, respectively (OR, 0.77; 95% CI, 0.5 to 1.19, P = 0.24). CONCLUSIONS: PACU discharge without assessment of lower limb motor function after spinal anesthesia for total hip or knee arthroplasty was noninferior to motor function assessment in achieving length of stay 4 days or less or 30-day readmissions. Because a nonsignificant tendency toward increased adverse events during the first 24 h in the ward was discovered, further safety data are needed in patients without assessment of lower limb motor function before PACU discharge.

Modular Neck vs Nonmodular Femoral Stems in Total Hip Arthroplasty-Clinical Outcome, Metal Ion Levels, and Radiologic Findings.

BACKGROUND: Modular neck femoral stem (MNFS) for total hip arthroplasty (THA) was introduced to optimize the outcome, but created concerns about pain, elevated blood metal ion levels, and adverse reaction to metal debris such as pseudotumors (PTs), related to corrosion between femoral neck and stem. We compared these outcomes in patients with MNFS or nonmodular femoral stem (NFS) THA. METHODS: Thirty-three patients with unilateral MNFS THA were compared with 30 patients with unilateral NFS THA. Levels of pain, serum cobalt, serum chromium were determined. Magnetic resonance imaging was performed to describe PT and fatty atrophy of muscles. RESULTS: The MNFS and NFS group had a mean follow-up of 2.3 and 3.1 years, respectively. Four and 13 patients in the MNFS and NFS group had pain, respectively (P = .005). The MNFS group had higher levels of serum cobalt (P < .0001) and chromium (P = .006). PTs were present in both the MNFS (n = 15) and NFS (n = 7) groups (P = .066). PTs were related to serum cobalt (P = .04) but not to pain or serum chromium. Fatty atrophy prevalence in the piriformis and gluteal muscles were higher in patients with MNFS (P = .009 and P = .032, respectively). CONCLUSION: More patients in the NFS group had pain. Serum cobalt and chromium levels were higher in the MNFS group. Prevalence of PTs was twice as high in the MNFS group, but the difference was insignificant.

Time-driven Activity-based Cost of Fast-Track Total Hip and Knee Arthroplasty.

BACKGROUND: Fast-track total hip and knee arthroplasty (THA and TKA) has been shown to reduce the perioperative convalescence resulting in less postoperative morbidity, earlier fulfillment of functional milestones, and shorter hospital stay. As organizational optimization is also part of the fast-track methodology, the result could be a more cost-effective pathway altogether. As THA and TKA are potentially costly procedures and the numbers are increasing in an economical limited environment, the aim of this study is to present baseline detailed economical calculations of fast-track THA and TKA and compare this between 2 departments with different logistical set-ups. METHODS: Prospective data collection was analyzed using the time-driven activity-based costing method (TDABC) on time consumed by different staff members involved in patient treatment in the perioperative period of fast-track THA and TKA in 2 Danish orthopedic departments with standardized fast-track settings, but different logistical set-ups. RESULTS: Length of stay was median 2 days in both departments. TDABC revealed minor differences in the perioperative settings between departments, but the total cost excluding the prosthesis was similar at USD 2511 and USD 2551, respectively. CONCLUSION: Fast-track THA and TKA results in similar cost despite differences in the organizational set-up. Compared to cost associated with longer more conventional published pathways, fast-track is cheaper, which on top of the favorable published clinical outcome adds to cost efficiency and the potential for economic savings. Detailed baseline TDABC calculations are provided for comparison and further optimization of cost-benefit effectiveness.

Feasibility of outpatient total hip and knee arthroplasty in unselected patients.

Background and purpose - The number of patients who are suitable for outpatient total hip and knee arthroplasty (THA and TKA) in an unselected patient population remains unknown. The purpose of this prospective 2-center study was to identify the number of patients suitable for outpatient THA and TKA in an unselected patient population, to investigate the proportion of patients who were discharged on the day of surgery (DOS), and to identify reasons for not being discharged on the DOS. Patients and methods - All consecutive, unselected patients who were referred to 2 participating centers and who were scheduled for primary THA and TKA were screened for eligibility for outpatient surgery with discharge to home on DOS. If patients did not fulfill the discharge criteria, the reasons preventing discharge were noted. Odds factors with relative risk intervals for not being discharged on DOS were identified while adjusting for age, sex, ASA score, BMI and distance to home. Results - Of the 557 patients who were referred to the participating surgeons during the study period, 54% were potentially eligible for outpatient surgery. Actual DOS discharge occurred in 13-15% of the 557 patients. Female sex and surgery late in the day increased the odds of not being discharged on the DOS. Interpretation - This study shows that even in unselected THA and TKA patients, same-day discharge is feasible in about 15% of patients. Future studies should evaluate safety aspects and economic benefits.

Do different types of bearings and noise from total hip arthroplasty influence hip-related pain, function, and quality of life postoperatively?

Background and purpose - Patient-reported outcome (PRO) is recognized as an important tool for evaluating the outcome and satisfaction after total hip arthroplasty (THA). We wanted to compare patient-reported outcome measure (PROM) scores from patients with ceramic-on-ceramic (CoC) THAs and those with metal-on-metal (MoM) THAs to scores from patients with metal-on-polyethylene (MoP) THAs, and to determine the influence of THA-related noise on PROM scores. Patients and methods - We conducted a nationwide cross-sectional questionnaire survey in a cohort of patients identified from the Danish Hip Arthroplasty Registry. The PROMs included were: hip dysfunction and osteoarthritis and outcome score (HOOS), EQ-5D-3L, EQ VAS, UCLA activity score, and questions about noise from the THA. The response rate was 85% and the number of responders was 3,089. Of these, 45% had CoC THAs, 17% had MoM THAs, and 38% had MoP THAs, with a mean length of follow-up of 7, 5, and 7 years, respectively. Results - Compared to MoP THAs, the mean PROM scores for CoC and MoM THAs were similar, except that CoC THAs had a lower mean score for HOOS Symptoms than did MoP THA. 27% of patients with CoC THAs, 29% with MoM THAs, and 12% with MoP THAs reported noise from their hip. For the 3 types of bearings, PROM scores from patients with a noisy THA were statistically significantly worse than those from patients with a silent MoP THA. The exception was noisy CoC and MoM THAs, which had the same mean UCLA activity score as silent MoP THAs. Interpretation - A high proportion of patients reported noise from the THA, and these patients had worse PROM scores than patients with silent MoP THAs.

Correlation between absence of bone remodeling compartment canopies, reversal phase arrest, and deficient bone formation in post-menopausal osteoporosis.

Bone remodeling compartments (BRCs) were recently recognized to be present in patients with primary hyperparathyroidism and critical for bone reconstruction in multiple myeloma and endogenous Cushing's syndrome. The BRCs are outlined by a cellular canopy separating the bone remodeling events on the bone surface from the marrow cavity. The present study on human iliac crest biopsy specimens reveals that BRC canopies appear frequently absent above both eroded and formative surfaces in post-menopausal osteoporosis patients, and that this absence was associated with bone loss in these patients. The absence of BRC canopies above the eroded surfaces was furthermore associated with the accumulation of arrested reversal surfaces and a reduced extent of formative surfaces, which both reflect an increased incidence of aborted remodeling cycles. Moreover, the absence of BRC canopies above formative surfaces was associated with a shift in the osteoblast morphological characteristics, from cuboidal to flattened. Collectively, this study shows that the BRCs are unique anatomical structures implicated in bone remodeling in a widespread disease, such as post-menopausal osteoporosis. Furthermore, it particularly highlights the role of the BRC canopies to make the reversal phase progressing toward initiation of matrix deposition, thereby preventing bone loss.

Oral Midodrine Hydrochloride for Prevention of Orthostatic Hypotension during Early Mobilization after Hip Arthroplasty: A Randomized, Double-blind, Placebo-controlled Trial.

BACKGROUND: Early postoperative mobilization is essential for rapid recovery but may be impaired by orthostatic intolerance (OI) and orthostatic hypotension (OH), which are highly prevalent after major surgery. Pathogenic mechanisms include an insufficient postoperative vasopressor response. The oral α-1 agonist midodrine hydrochloride increases vascular resistance, and the authors hypothesized that midodrine would reduce the prevalence of OH during mobilization 6 h after total hip arthroplasty relative to placebo. METHODS: This double-blind, randomized trial allocated 120 patients 18 yr or older and scheduled for total hip arthroplasty under spinal anesthesia to either 5 mg midodrine hydrochloride or placebo orally 1 h before mobilization at 6 and 24 h postoperatively. The primary outcome was the prevalence of OH (decrease in systolic or diastolic arterial pressures of > 20 or 10 mmHg, respectively) during mobilization 6 h after surgery. Secondary outcomes were OI and hemodynamic responses to mobilization at 6 and 24 h. RESULTS: At 6 h, 14 (25%; 95% CI, 14 to 38%) versus 23 (39.7%; 95% CI, 27 to 53%) patients had OH in the midodrine and placebo group, respectively, relative risk 0.63 (0.36 to 1.10; P = 0.095), whereas OI was present in 15 (25.0%; 15 to 38%) versus 22 (37.3%; 25 to 51%) patients, relative risk 0.68 (0.39 to 1.18; P = 0.165). At 24 h, OI and OH prevalence did not differ between groups. CONCLUSIONS: Preemptive use of oral 5 mg midodrine did not significantly reduce the prevalence of OH during early postoperative mobilization compared with placebo. However, further studies on dose and timing are warranted since midodrine is effective in chronic OH conditions.

Comparison of the risk of revision in cementless total hip arthroplasty with ceramic-on-ceramic and metal-on-polyethylene bearings.

BACKGROUND AND PURPOSE: Ceramic-on-ceramic (CoC) bearings were introduced in total hip arthroplasty (THA) to reduce problems related to polyethylene wear. We compared the 9-year revision risk for cementless CoC THA and for cementless metal-on-polyethylene (MoP) THA. PATIENTS AND METHODS: In this prospective, population-based study from the Danish Hip Arthroplasty Registry, we identified all the primary cementless THAs that had been performed from 2002 through 2009 (n = 25,656). Of these, 1,773 THAs with CoC bearings and 9,323 THAs with MoP bearings were included in the study. To estimate the relative risk (RR) of revision, we used regression with the pseudo-value approach and treated death as a competing risk. RESULTS: 444 revisions were identified: 4.0% for CoC THA (71 of 1,773) and 4.0% for MoP THA (373 of 9,323). No statistically significant difference in the risk of revision for any reason was found for CoC and MoP bearings after 9 years of follow-up (adjusted RR = 1.3, 95% CI: 0.72-2.4). Revision rates due to component failure were 0.5% (n = 8) for CoC bearings and 0.1% (n = 6) for MoP bearings (p < 0.001). 6 patients with CoC bearings (0.34%) underwent revision due to ceramic fracture. INTERPRETATION: When compared to the "standard" MoP bearings, CoC THA had a 33% higher (though not statistically significantly higher) risk of revision for any reason at 9 years.

The "true" incidence of surgically treated deep prosthetic joint infection after 32,896 primary total hip arthroplasties: a prospective cohort study.

BACKGROUND AND PURPOSE: It has been suggested that the risk of prosthetic joint infection (PJI) in patients with total hip arthroplasty (THA) may be underestimated if based only on arthroplasty registry data. We therefore wanted to estimate the "true" incidence of PJI in THA using several data sources. PATIENTS AND METHODS: We searched the Danish Hip Arthroplasty Register (DHR) for primary THAs performed between 2005 and 2011. Using the DHR and the Danish National Register of Patients (NRP), we identified first revisions for any reason and those that were due to PJI. PJIs were also identified using an algorithm incorporating data from microbiological, prescription, and clinical biochemistry databases and clinical findings from the medical records. We calculated cumulative incidence with 95% confidence interval. RESULTS: 32,896 primary THAs were identified. Of these, 1,546 had first-time revisions reported to the DHR and/or the NRP. For the DHR only, the 1- and 5-year cumulative incidences of PJI were 0.51% (0.44-0.59) and 0.64% (0.51-0.79). For the NRP only, the 1- and 5-year cumulative incidences of PJI were 0.48% (0.41-0.56) and 0.57% (0.45-0.71). The corresponding 1- and 5-year cumulative incidences estimated with the algorithm were 0.86% (0.77-0.97) and 1.03% (0.87-1.22). The incidences of PJI based on the DHR and the NRP were consistently 40% lower than those estimated using the algorithm covering several data sources. INTERPRETATION: Using several available data sources, the "true" incidence of PJI following primary THA was estimated to be approximately 40% higher than previously reported by national registries alone.

Understanding coupling between bone resorption and formation: are reversal cells the missing link?

Bone remodeling requires bone resorption by osteoclasts, bone formation by osteoblasts, and a poorly investigated reversal phase coupling resorption to formation. Likely players of the reversal phase are the cells recruited into the lacunae vacated by the osteoclasts and presumably preparing these lacunae for bone formation. These cells, called herein reversal cells, cover >80% of the eroded surfaces, but their nature is not identified, and it is not known whether malfunction of these cells may contribute to bone loss in diseases such as postmenopausal osteoporosis. Herein, we combined histomorphometry and IHC on human iliac biopsy specimens, and showed that reversal cells are immunoreactive for factors typically expressed by osteoblasts, but not for monocytic markers. Furthermore, a subpopulation of reversal cells showed several distinctive characteristics suggestive of an arrested physiological status. Their prevalence correlated with decreased trabecular bone volume and osteoid and osteoblast surfaces in postmenopausal osteoporosis. They were, however, virtually absent in primary hyperparathyroidism, in which the transition between bone resorption and formation occurs optimally. Collectively, our observations suggest that arrested reversal cells reflect aborted remodeling cycles that did not progress to the bone formation step. We, therefore, propose that bone loss in postmenopausal osteoporosis does not only result from a failure of the bone formation step, as commonly believed, but also from a failure at the reversal step.

The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol.

BACKGROUND: The age- and gender-specific incidence of total hip replacement surgery has increased over the last two decades in all age groups. Recent studies indicate that non-surgical interventions are effective in reducing pain and disability, even at later stages of the disease when joint replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone. METHODS/DESIGN: A prospective, blinded, parallel-group multi-center trial (2 sites), with balanced randomization [1:1]. Patients with hip osteoarthritis and an indication for hip replacement surgery, aged 40 years and above, will be consecutively recruited and randomized into two treatment groups. The active treatment group will receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for assessing the effectiveness of the intervention is 12 months after baseline. However, follow-ups will also be performed once a year for at least 5 years. The primary outcome measure is the time to hip replacement surgery measured on a Kaplain-Meier survival curve from time of inclusion. Secondary outcome measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity level (UCLA activity score), and patient's global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical muscle strength and performance in physical tests. A cost-effectiveness analysis will also be performed. DISCUSSION: To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with an indication for surgery on the time to total hip replacement. TRIAL REGISTRATION: NCT01697241.

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.

Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.