Multiplex PCR test as an intra-operative diagnostic tool for periprosthetic joint infection in presumed aseptic revision hip and knee arthroplasty: a 1-year follow-up study of 200 cases.

Automated custom-made multiplex PCR techniques (mPCR) have become commercially available and are designed for intra-operative screening of concurrent periprosthetic joint infections (PJIs). The purpose of this study was to evaluate the value of a positive mPCR test in presumed aseptic revision total hip (THA) and knee (TKA) arthroplasties after a 1-year follow-up. In an earlier study, such an automated mPCR technique (Unyvero ITI G2; Curetis, Holzgerlingen, Germany) was tested on intra-operatively obtained synovial fluid in 200 patients with a presumed aseptic TKA or THA revision. At the time of revision, no therapeutic consequences were attached to a positive test result since treating personnel were blinded for the test results. We retrospectively reviewed the outcome of cases with respect to the occurrence of PJIs using the European Bone and Joint Infection Society (EBJIS) criteria during a 1-year follow-up postoperatively. A total of 10 out of 200 patients had a positive mPCR test result at the time of revision. Of these 10 cases, none encountered outcome parameters fulfilling the criteria to diagnose PJIs in the first year after surgery, and one required re-revision surgery for reasons other than infection. Of the other 190 negative mPCR cases, none developed a PJI. A positive mPCR test at the time of presumed aseptic revision surgery did not correspond with intra-operatively obtained tissue cultures, and none of the encountered positive mPCR tests had developed a PJI at the 1-year follow-up. We recommend careful evaluation and monitoring of modern diagnostic tests before widespread use.

No difference in bacterial contamination of hip capsule sutures and control sutures in hip arthroplasty surgery.

BACKGROUND: Perioperative preventive measures are important to further reduce the rate of periprosthetic joint infections (PJI) in patients undergoing total hip arthroplasty (THA). During THA surgery, joint capsule sutures are commonly placed to optimize exposure and reinsertion of the capsule. Bacterial contamination of these sutures during the procedure poses a potential risk for postoperative infection. In this exploratory study, we assessed the contamination rate of capsule sutures compared to the contamination of the remains of exchanged control sutures at the time of closure. METHODS: In 100 consecutive patients undergoing primary THA capsule sutures were exchanged by sterile sutures at the time of capsule closure. Both the original sutures and the remainder of the newly placed (control) sutures were retrieved, collected and cultured for ten days. Types of bacterial growth and contamination rates of both sutures were assessed. RESULTS: Sutures from 98 patients were successfully collected and analyzed. Bacterial growth was observed in 7/98 (7.1%) of the capsule sutures versus 6/98 (6.1%) of the control sutures, with a difference of 1% [CI -6-8]. There was no clear pattern in differences in subtypes of bacteria between groups. CONCLUSIONS: This study showed that around 7% of capsule sutures used in primary THA were contaminated with bacteria and as such exchange by new sutures at the time of capsule closure could be an appealing PJI preventive measure. However, since similar contamination rates were encountered with mainly non-virulent bacteria for both suture groups, the PJI preventive effect of this measure appears to be minimal.

Revision risk of salvage compared with acute total hip arthroplasty following femoral neck fracture: an analysis from the Dutch Arthroplasty Register.

BACKGROUND AND PURPOSE: There is no consensus on the treatment of patients with femoral neck fractures between internal fixation (IF) or directly treated with a total hip arthroplasty (fracture-THA) in particular for the age group 60-70 years. Failure of IF is not uncommon, resulting in salvage total hip arthroplasty (salvage-THA). The aim of our study was to compare revision rates of salvage-THA with fracture-THA and osteoarthritis (OA)-THA. PATIENTS AND METHODS: Revision rates and reasons for revision were compared. Data collected in the Dutch Arthroplasty Register (LROI) between 2007 and 2018 was used. The study included 4,310 salvage-THAs, 12,159 fracture-THAs, and 274,147 OA-THAs. We performed Kaplan-Meier survival analyses and Cox regression to evaluate THA survival. RESULTS: No statistically significant difference in revision rates between salvage-THAs and fracture-THAs was found (HR 1.0, 95% CI 0.7-1.3) whereas the revision rate was higher compared with OA-THAs (HR 1.3, CI 1.0-1.5). The 5-year revision rate was 5.0% (CI 4.4-5.8) in salvage-THAs, 4.5% (CI 4.1-5.0) in fracture-THAs, and 3.1% (CI 3.0-3.2) in OA-THAs. A higher revision rate for infection was found in salvage-THAs in comparison with fracture-THAs (HR 1.6, CI 1.0-2.3). CONCLUSION: We found no difference in revision rates for salvage-THAs compared with fracture-THAs. The risk of revision for infection was higher for salvage-THA.

Empiric antibiotic therapy in early periprosthetic joint infection: a retrospective cohort study.

PURPOSE: Periprosthetic joint infection (PJI) is a devastating complication following total knee or total hip arthroplasty (TKA/THA). Appropriate empiric antibiotic treatment, initiated directly after debridement and implant retention (DAIR), is suggested to contribute to treatment success. The aim of this study was to describe the microbiology and the antibiotic susceptibility in early PJI to guide future empiric treatment in a region with a low incidence of methicillin-resistant Staphylococcus aureus (MRSA). METHODS: Consecutive patients who underwent DAIR within 3 months after primary unilateral TKA or THA between January 2011 and December 2018 were retrospectively identified from the hospital electronic health records. Data on causative pathogens, antimicrobial susceptibility and the number of post-operative days until cultures demonstrated bacterial growth were collected. RESULTS: One hundred and eleven early PJIs were identified of which 65 (59%) were monomicrobial and 46 (41%) polymicrobial. Among all isolated pathogens, Staphylococcus aureus (n = 53; 29%) was the most commonly identified pathogen in early PJI without any involvement of MRSA. 72% of PJIs were susceptible to vancomycin which could be increased to around 90% by adding gram-negative coverage. On the 5th postoperative day, bacterial growth was observed in 98% of cases. All gram-negative bacteria demonstrated positive tissue cultures on the 4th postoperative day. CONCLUSION: Vancomycin combined with ciprofloxacin or a third generation cephalosporin provided the highest antimicrobial coverage of all responsible pathogens identified in early PJI. Empiric treatment of gram-negative treatment can be safely terminated in the absence of gram-negative pathogens after 4 days of culturing in cases without preoperative antibiotic treatment.

Cost-effectiveness of full endoscopic versus open discectomy for sciatica.

OBJECTIVE: To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica. METHODS: This economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness. RESULTS: Of the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, €4500/patient vs €4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs. CONCLUSIONS: Our results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica. TRIAL REGISTRATION NUMBER: NCT02602093.

Lumbar Epidural Lipomatosis is Increased in Patients With Morbid Obesity and Subsequently Decreases After Bariatric Surgery.

BACKGROUND: Spinal epidural lipomatosis (SEL) is characterized by symptomatic neurogenic compression from adipose tissue in the spinal canal. The question arises whether patients with morbid obesity have higher volumes of epidural adipose tissue (EAT) in their lumbar spinal canal compared with patients with a normal weight, and to what extent this decreases after bariatric surgery. METHODS: In this explorative study the lumbar EAT volume was assessed in 25 patients with morbid obesity (body mass index [BMI] >40) using available lumbar magnetic resonance imaging (MRI) prior to their bariatric surgery. An age- and sex-matched control group (n = 25) of patients with a normal weight (BMI 20-25) was used for comparison. Participants from the obesity group underwent a postoperative control MRI. RESULTS: The mean volume of EAT per MRI slice of the group of patients with obesity was significantly higher than for the group of patients with normal weight (mean: 83.3 ± 30.7 mm3 vs. mean 56.5 ± 25 mm3; P < 0.001). Fifteen participants with obesity (15 of 25) agreed to undergo a follow-up MRI. There was a significant decrease in EAT volume per MRI slice for these 15 participants (mean 82 ± 25.5 mm3 vs. 46 ± 20.0 mm3; P < 0.001) over time up to 3.6 (range: 1.2-6.0) years after bariatric surgery. CONCLUSIONS: Patients with obesity have significantly larger volumes of EAT in comparison with patients with normal weight. After bariatric surgery, a significant weight loss coincided with a significant volumetric reduction of this adipose tissue in the spinal canal. Future prospective studies in patients with symptomatic SEL may elucidate whether decreases in EAT volume influence concurrent neurogenic claudication symptoms.

Nonoperative management of hip fractures in very frail elderly patients may lead to a predictable short survival as part of advance care planning.

Background and purpose - Surgical treatment is still the mainstay of care even in very frail elderly hip fracture patients. However, one may argue whether surgery is in the best interest of all patients. We elucidated mortality rates of nonoperative management (NOM) of a hip fracture after shared decision-making in a cohort of very frail elderly patients.Patients and methods - Orthogeriatric patients (age > 70 years) admitted with a hip fracture between 2011 and 2019 were included. In the presence of fragility features the motivation for surgery or NOM was supported by advance care planning (ACP) and shared decision-making through geriatric assessment. Mortality rates after NOM were assessed and also presented for the remaining surgical group for reference.Results - In 1,279 out of 3,467 patients, geriatric assessment was indicated and subsequently 1,188 (93%) had surgery versus 91 (7%) NOM. The motivation for NOM was based on patient and family preferences in only 20% of patients, medical grounds in 54%, and a combination of both in 26%. The 30-day and 1-year mortality in the frail NOM group was 87% and 99% respectively, whereas this was 7% and 28% in the surgery group. No statistical comparison between groups was performed due to profound bias by indication.Interpretation - This study provides further insight into the predictable and high short-term mortality after NOM in carefully selected very frail elderly hip fracture patients. This information may help to consider NOM as an alternative treatment option to surgery when no significant gain from surgery is anticipated.

The (un)necessity of regular postoperative follow-up of hemiarthroplasty for femoral neck fractures.

BACKGROUND: Postoperative follow-up after hemiarthroplasty is part of routine based practice. However, these visits appear to be a significant burden since it concerns a frail population. The aim of this study was to confirm the current common practice regarding postoperative visits of patients treated with hemiarthroplasty and to evaluate the complication detection rate at these visits. METHODS: A national short survey was conducted among orthopedic surgeons working in 26 large Dutch teaching hospitals to test the hypothesis that postoperative follow-up is indeed common practice. Furthermore, a retrospective patient review was performed in all hemiarthroplasties implanted between January 2014 and December 2019. RESULTS: The response of the national survey was complete and showed that postoperative follow-up in patients treated with hemiarthroplasty is part of standard care according to 89% of respondents. A total of 1055 hips (1026 patients) were implanted with hemiarthroplasty during the studied period. Implant-related complications were identified in 68 hemiarthroplasties, with 31 of these hips going on to reoperation. Only 2 of these complications were picked up at standard planned follow-up leading to a complication detection rate of 0.3%. In contrast, complication detection rates of 47% and 16% were found at unplanned visits at the Emergency Department and the outpatient department, respectively. CONCLUSIONS: Postoperative follow-up in patients treated with hemiarthroplasty is still the standard of care. However, this study revealed that the majority of implant-related complications are detected at unplanned visits and almost no at standard follow-up visits. Postoperative follow-up of patients treated with hemiarthroplasty could be abandoned in this frail population.

A Swallowing Screening Test Enhances a Better Recognition of Patients with a Hip Fracture at Risk for Oropharyngeal Dysphagia.

Oropharyngeal dysphagia (OD) is commonly encountered in elderly patients with hip fracture. It is easily overlooked and predisposes patients to life-threatening postoperative pneumonia. The aim of this study was to evaluate whether OD screening by nurses results in a better recognition of patients at risk for OD. After the introduction of the Standardized Swallowing Assessment by nurses, the incidence of increased risk for OD and the prevention of OD complications were monitored (intervention group; N = 92) and compared with a historical control group (N = 81). The risk for OD was diagnosed in 27 patients (29%) in the intervention group in comparison with 12 patients (15%) in the control group (p < .05). The number of diet modifications increased from 12 (15%) in the control group to 25 (27%) in the intervention group (p < .05). A simple screening test results in better recognition of increased OD risk and, in turn, the early initiation of measures to avoid aspiration.

Preoperative Staphylococcus aureus screening and eradication.

AIMS: Preoperative nasal Staphylococcus aureus screening and eradication reduces surgical site infections (SSIs) but its impact on reducing early prosthetic joint infection (PJI) remains controversial. This study aims to assess the effect of preoperative nasal S. aureus screening and eradication on the incidence of early PJI in general and S. aureus-induced early PJI. METHODS: All primary total hip arthroplasties (THA) and total knee arthroplasties (TKA) performed from January 2006 to April 2018 were retrospectively reviewed for the incidence of early PJI. Demographic parameters, risk factors for PJI (American Society of Anaesthesiologists classification, body mass index, smoking status, and diabetes mellitus) and implant types were collected. A preoperative screening and eradication protocol for nasal colonization of S. aureus was introduced in October 2010. The incidence of early PJI was compared before and after the implementation of the protocol. Missing data were imputed via multiple imputation by chained equations. Inverse probability weighting was used to account for differences between patients in both groups. Weighted univariate logistic regression was used to evaluate the incidence of early PJI for both groups. RESULTS: In total, 10,486 THAs and TKAs were performed in the research period. After exclusion, a cohort of 5,499 screened cases and 3,563 non-screened cases were available for analysis. Overall, no significant reduction in early PJI was found in the screened group (odds ratio (OR) 0.78, 95% confidence interval (CI) 0.55 to 1.11; p = 0.173). However, the incidence of S. aureus-induced PJI was significantly reduced (OR 0.58, 95% CI 0.36 to 0.92; p = 0.027) in the screened group. CONCLUSION: A preoperative nasal S. aureus screening and eradication protocol did not significantly reduce the overall incidence of early PJI after THA or TKA. However, a decreased incidence of S. aureus-induced early PJI was established. These findings can help to establish better consensus around the value of these screening protocols. Cite this article: Bone Joint J 2020;102-B(10):1341-1348.

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

STUDY DESIGN: Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery. OBJECTIVES: The aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass. SUMMARY OF BACKGROUND DATA: There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting. METHODS: A total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P < 0.05). RESULTS: The 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P < 0.001), but no difference between the grafts (P = 0.595). Ongoing bone formation was only observed between the facet joints. CONCLUSION: This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting. LEVEL OF EVIDENCE: 1.

General anesthesia might be associated with early periprosthetic joint infection: an observational study of 3,909 arthroplasties.

Background and purpose - Periprosthetic joint infection (PJI) remains a devastating complication following total knee or total hip arthroplasty (TKA/THA). Nowadays, many studies focus on preventive strategies regarding PJI; however, the potential role of anesthesia in the development of PJI remains unclear.Patients and methods - All consecutive patients undergoing elective primary unilateral TKA or THA from January 2014 through December 2017 were included. Exclusion criteria included femoral fractures as the indication for surgery and previously performed osteosynthesis or hardware removal on the affected joint. Age, sex, BMI, ASA classification, type of arthroplasty surgery, type of anesthesia, duration of surgery, smoking status, and intraoperative hypothermia were recorded. Propensity score-matched univariable logistic regression analysis was used to control for allocation bias.Results - 3,909 procedures consisting of 54% THAs and 46% TKAs were available for analysis. 42% arthroplasties were performed under general anesthesia and 58% under spinal anesthesia. Early PJIs were observed in 1.7% of the general anesthesia group and in 0.8% in the spinal anesthesia group. The multivariable logistic regression model demonstrated an odds ratio for PJI of 2.0 (95% CI 1.0-3.7) after general anesthesia relative to the propensity score-matched patients who received spinal anesthesia.Interpretation - These results suggest a potential association between general anesthesia and early PJI. Future research using large-scale data is required to further elucidate this clinically relevant association.

High incidence of early periprosthetic joint infection following total hip arthroplasty with concomitant or previous hardware removal.

INTRODUCTION: Hardware removal preceding total hip arthroplasty may increase the risk of prosthetic joint infection (PJI). Whether hardware removal and total hip arthroplasty (THA) should be performed in a single- or two-stage procedure remains controversial. In this comparative retrospective study, the incidence of PJI following either single- or two-stage THA with hardware removal was assessed in a consecutive series. PATIENTS AND METHODS: All patients that underwent THA preceded by hardware removal from January 2006 until March 2018 were retrospectively reviewed and checked for the occurrence of early PJI. Recognized risk factors for PJI at the time of surgery were evaluated and the incidence of early PJI was compared between one- and two-stage THA regarding hardware removal. RESULTS: 145 patients underwent THA and hardware removal (52 two-stage surgery and 93 single-stage surgery). There were no significant differences between both groups regarding pre-operative hemoglobulin levels, time interval between internal fixation and THA, antibiotic-loaded-cement use, BMI and ASA classification. Overall the incidence of early PJI was 6.9%. The incidence of PJI was 8.6% in the single-stage group versus 3.8% in the two-stage group (P = 0.234). CONCLUSION: Irrespective of single- or two-stage procedures, a high incidence of PJI was encountered. Despite non-significance, a trend towards a higher proportion of patients developing PJI after single-stage surgery was encountered. We recommend a two-stage surgical procedure regarding hardware removal and THA in patients that are expected to tolerate this surgical strategy. When considering a one-stage procedure, it should be preceded by a thorough pre-operative workup including joint aspiration and serum determination of inflammatory parameters. Multiple tissue samples should be obtained during hardware removal in either one- or two-stage procedures since the risk for development of PJI is relevant.

Patients Cannot Reliably Distinguish the Iliac Crest Bone Graft Donor Site From the Contralateral Side After Lumbar Spine Fusion: A Patient-blinded Randomized Controlled Trial.

STUDY DESIGN: A multicenter, randomized, intrapatient controlled trial. OBJECTIVE: This study investigated whether lumbar fusion patients blinded to the harvest site (A) can identify the iliac crest used for bone harvesting and (B) whether this iliac crest is more painful than the contralateral side. SUMMARY OF BACKGROUND DATA: Spinal fusion with iliac crest autograft is a frequently performed surgical procedure. A widely reported disadvantage of the harvesting procedure is potential donor site morbidity. This has driven the development of many bone graft substitutes. However, more recently the incidence and severity of donor site pain is debated, especially in lumbar fusion surgery. METHODS: Ninety-two nontraumatic adult patients underwent a posterolateral (thoraco)lumbar fusion. Iliac crest bone graft was harvested unilaterally through the primary midline incision. At 6 weeks, 3 months, 6 months, and 1 year follow-up, patients were asked to identify the donor site and to rate pain in their back, left iliac crest and right iliac crest on a Visual Analogue Scale (VAS). RESULTS: Ninety patients, 44 males and 46 females with a mean age of 54 years, were analyzed. The left/right distribution of the iliac crest donor site was 50/50 and 89% of the patients underwent a lumbar fusion below L3. Only 24% patients identified the harvest site correctly. Moreover, the VAS pain scores for the donor site and contralateral iliac crest did not differ and were at each timepoint lower than the scores for back pain. CONCLUSION: This study showed that, during the first year after lumbar fusion surgery via a single midline incision approach, patients could not reliably identify the iliac crest used for bone graft harvesting and this iliac crest was not more painful than the untouched contralateral iliac crest. Therefore, donor site pain should not be the main reason to use bone graft alternatives for lumbar spinal fusion. LEVEL OF EVIDENCE: 2.

High incidence of intraoperative calcar fractures with the cementless CLS Spotorno stem.

INTRODUCTION: This study reports on the incidence of intraoperative calcar fractures with the cementless Spotorno (CLS) stem, and the potential role of a learning curve and implant positioning is investigated. METHODS: After introduction of the CLS stem, 800 consecutive cementless total hip arthroplasties (THA) were analyzed. The incidence of calcar fracture in the first 400 THA was compared with the second 400 THA, in order to study a potential learning curve effect. According to the instruction for users, varus positioning of the stem was avoided and a femoral neck osteotomy was aimed relatively close to the lesser trochanter since these are assumed to be correlated with calcar fractures. Implant positioning (neck-shaft angle, femoral offset and osteotomy-lesser trochanter distance) was measured on postoperative pelvic radiographs of all THA with calcar fractures and 100 randomly selected uncomplicated control cases. RESULTS: Seventeen (2.1%) intraoperative calcar fractures were recorded. The incidence of calcar fracture differed between the first 400 THA (n = 11) and the second 400 THA (n = 6). This difference was not statistically significant (p = 0.220); however, these numbers indicate a trend toward a learning effect. No significant difference in stem positioning nor the height of the femoral neck osteotomy was measured between THA with a calcar fracture (n = 17) and the control cases (n = 100). CONCLUSIONS: We report on a high incidence of intraoperative calcar fractures with the use of a CLS stem. The risk for calcar fractures remains clinically significant even after adequate implant positioning in the hands of experienced hip surgeons. Surgeons should be aware of this implant related phenomenon and be alert on this phenomenon intraoperatively.

Bone mineral density changes in the graft after acetabular impaction bone grafting in primary and revision hip surgery.

Background and purpose - Impaction bone grafting (IBG) is an established method in hip revision surgery to reconstruct loss of bone stock. There is limited knowledge concerning the actual bone remodelling process within the allograft. We investigated with repeated bone mineral density (BMD) measurements the biological process of bone remodelling in the allograft in vivo. We hypothesized that an initial decrease in BMD would be followed by an increase towards baseline values. Patients and methods - Dual-energy X-ray absorptiometry (DXA) was used to measure BMD values in 3 regions of interest (ROI) in 20 patients (average age at surgery 70 years, 11 males) after an acetabular reconstruction with IBG and a cemented cup. A postoperative DXA was used as baseline and DXA was repeated at 3 and 6 months and at 1 and 2 years. The Oxford Hip Score (OHS), the 12-Item Short Form Health Survey (SF12), and a 0 to 100 mm visual analogue scale (VAS) for pain and satisfaction were obtained simultaneously. Results - The overall mean BMD in the IBG regions increased significantly by 9% (95% CI 2-15) at 2 years' follow-up. In the cranial ROI BMD increased 14% (CI 6-22), whereas the BMD in the medial and caudal ROI showed an increase of 10% (CI 1-18) and 4% (CI -6-16), respectively. The OHS, SF12-mental, and VAS for pain all improved statistically significantly 2 years after surgery, with a mean VAS for satisfaction of 77 (CI 63-90) out of 100 points. The SF12-physical showed non-significant improvement. Interpretation - The BMD in the allograft gradually increased after IBG for acetabular reconstruction arthroplasties, particularly in the cranial ROI. An initial decrease in the BMD was not encountered. These BMD changes, as proxy measurements for bone remodeling, may indicate progressive apposition of vital new host bone in the grafted area.

Low sensitivity of a-defensin (Synovasure) test for intra-operative exclusion of prosthetic joint infection.

Background and purpose - The Synovasure lateral flow test was developed as a rapid test for the detection or exclusion of periprosthetic joint infection (PJI). 3 studies have reported promising results on its diagnostic value in total joint revision surgery. We aimed to assess the sensitivity and specificity of the Synovasure test to exclude infection in patients undergoing revision surgery for suspected early aseptic loosening of a total hip or knee arthroplasty. Patients and methods - In a prospective study design, 37 patients who underwent revision surgery for suspected early aseptic loosening (< 3 years after primary arthroplasty) were included. The Synovasure test was used intraoperatively to confirm the aseptic nature of the loosening and 6 tissue cultures were obtained in all cases. Exclusion criteria were patients with a preoperatively confirmed PJI, acute revisions (< 90 days after primary arthroplasty) and cases with malpositioning, wear, or instability of the prosthesis. Results - 5 of the 37 patients were diagnosed with a PJI based on the intraoperative tissue cultures. In only 1 out of these 5 cases this was confirmed by the intraoperative Synovasure test. No tests were falsely positive. Interpretation - In this case series the Synovasure lateral flow test had a low sensitivity to exclude PJI in patients with suspected aseptic loosening. The role of the Synovasure lateral flow test in the intraoperative exclusion of PJI during revision surgery for suspected early aseptic loosening appears to be more limited than previously indicated.

Lessons learnt from early failure of a patient trial with a polymer-on-polymer resurfacing hip arthroplasty.

Background and purpose - Hip resurfacing (HR) is a treatment option promoted for hip arthritis in young and active patients. However, adverse reactions to metal are a concern and the search for non-metallic bearing options proceeds. We present the first clinical study performed in patients using a newly developed hydrophilic polymer-on-polymer hip resurfacing device. Patients and methods - After performing extensive hip simulator tests, biocompatibility testing and animal tests (ISO 14242-1,3; 10993-3,4,5,10,11), approval was obtained from the IRB committee to enroll 15 patients in the first clinical study in humans using this experimental polymer-on-polymer hip resurfacing device. All surgeries were done by 2 experienced hip resurfacing surgeons. Clinical scores and standard radiographs as well as routine MRIs were obtained at regular intervals. Results - The surgical technique proved feasible with successful implantation of the new device using PMMA cement fixation on both sides without complications. Postoperative imaging revealed a well-positioned and well-fixed polymer resurfacing hip arthroplasty in all 4 initial cases. All 4 patients were free of pain and had good function for the first 2 months. However, in all 4 cases early cup loosening occurred between 8 and 11 weeks after surgery, necessitating immediate closure of the study. All 4 patients had a reoperation and were revised to a conventional THA. Retrieval analyses confirmed early cup loosening at the implant-cement interface in all 4 cases. The femoral components remained well attached to the cement. The periprosthetic tissues showed only small amounts of polymeric wear debris and there was only a very mild inflammatory reaction to this. Interpretation - Early cup loosening mandated a premature arrest of this study. After additional laboratory testing this failure mode was found to be the result of a small, yet measurable contraction in the cup size after exposing these implants to biological fluid divalent ion fluctuations in vivo. Currently used preclinical tests had failed to detect this failure mechanism. Modification of the polymer is essential to overcome these problems and before the potential of a polymer-on-polymer resurfacing arthroplasty may be further evaluated in patients.

OP-1 Compared with Iliac Crest Autograft in Instrumented Posterolateral Fusion: A Randomized, Multicenter Non-Inferiority Trial.

BACKGROUND: Spinal fusion with the use of autograft is a commonly performed procedure. However, harvesting of bone from the iliac crest is associated with complications. Bone morphogenetic proteins (BMPs) are extensively used as alternatives, often without sufficient evidence of safety and efficacy. The purpose of this study was to investigate non-inferiority of osteogenic protein-1 (OP-1, also known as BMP-7) in comparison with iliac crest bone graft in posterolateral fusions. METHODS: This study was a randomized, controlled multicenter trial. Patients who underwent a single-level instrumented posterolateral fusion of the lumbar spine for degenerative or isthmic spondylolisthesis with symptoms of neurological compression were randomized to receive OP-1 combined with local bone (OP-1 group) or autologous bone graft from the iliac crest combined with local bone (autograft group). The primary outcome was overall success, defined as a combination of clinical success and evidence of fusion on computed tomography (CT) scans, at one year postoperatively. RESULTS: One hundred and nineteen patients were included in the study, and analysis of the overall outcome was performed for 113. Non-inferiority of OP-1 compared with iliac crest autograft was not found at one year, with a success rate of 40% in the OP-1 group versus 54% in the autograft group (risk difference = -13.3%, 90% confidence interval [CI] = -28.6% to +2.10%). This was due to the lower rate of fusion (the primary aim of OP-1 application) seen on the CT scans in the OP-1 group (54% versus 74% in the autograft group, p = 0.03). There were no adverse events that could be directly related to the use of OP-1. CONCLUSIONS: OP-1 with a collagen carrier was not as effective as autologous iliac crest bone for achieving fusion and cannot be recommended in instrumented posterolateral lumbar fusion procedures. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Metal ion levels and functional results following resurfacing hip arthroplasty versus conventional small-diameter metal-on-metal total hip arthroplasty; a 3 to 5year follow-up of a randomized controlled trial.

We present an update of a randomized controlled trial on 71 patients (<65 years) who received either a resurfacing hip arthroplasty (RHA) (n=38) or cementless 28-mm metal-on-metal (MoM) total hip arthroplasty (THA) (n=33). Metal ion levels and functional outcome scores were analyzed with a mean follow-up of 58 months (SD 8.1). No clear shifts in relatively good outcome was encountered between RHA and THA. Metal ion levels appear to equalize between groups after 3 years. Median cobalt and chromium remained below 1.3 µg/L throughout follow-up in both groups. Six revisions were performed, of which three for pseudotumor formation (one THA, two RHA). In conclusion there were no clinical differences between the two groups and metal ion levels were lower than other series remained low, however, pseudotumor formation was not eliminated.