Orthopedic device-related infection (ODRI) preclinical models are widely used in translational research. Most models require induction of general anesthesia, which frequently results in hypothermia in rodents. This study aimed to evaluate the impact of peri anesthetic hypothermia in rodents on outcomes in preclinical orthopedic device-related infection studies. A retrospective analysis of all rodents that underwent surgery under general anesthesia to induce an ODRI model with inoculation of Staphylococcus epidermidis between 2016 and 2020 was conducted. A one-way multivariate analysis of covariance was used to determine the fixed effect of peri anesthetic hypothermia (hypothermic defined as rectal temperature <35°C) on the combined harvested tissue and implant colonies forming unit counts, and having controlled for the study groups including treatments received duration of surgery and anesthesia and study period. All animal experiments were approved by relevant ethical committee. A total of 127 rodents (102 rats and 25 mice) were enrolled in an ODRI and met the inclusion criteria. The mean lowest peri-anesthetic temperature was 35.3 ± 1.5 °C. The overall incidence of peri-anesthetic hypothermia was 41% and was less frequently reported in rats (34% in rats versus 68% in mice). Statistical analysis showed a significant effect of peri anesthetic hypothermia on the post-mortem combined colonies forming unit counts from the harvested tissue and implant(s) (p=0.01) when comparing normo- versus hypothermic rodents. Using Wilks’ Λ as a criterion to determine the contribution of independent variables to the model, peri-anesthetic hypothermia was the most significant, though still a weak predictor, of increased harvested colonies forming unit counts. Altogether, the data corroborate the concept that bacterial colonization is affected by abnormal body temperature during general anesthesia at the time of bacterial inoculation in rodents, which needs to be taken into consideration to decrease infection data variability and improve experimental reproducibility

Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S

We carried out a cross-sectional study with analysis of the demographic, clinical and laboratory characteristics of patients with metal-on-metal hip resurfacing, ceramic-on-ceramic and metal-on-polyethylene hip replacements. Our aim was to evaluate the relationship between metal-on-metal replacements, the levels of cobalt and chromium ions in whole blood and the absolute numbers of circulating lymphocytes. We recruited 164 patients (101 men and 63 women) with hip replacements, 106 with metal-on-metal hips and 58 with non-metal-on-metal hips, aged < 65 years, with a pre-operative diagnosis of osteoarthritis and no pre-existing immunological disorders. Laboratory-defined T-cell lymphopenia was present in13 patients (15%) (CD8. +. lymphopenia) and 11 patients (13%) (CD3. +. lymphopenia) with unilateral metal-on-metal hips. There were significant differences in the absolute CD8. +. lymphocyte subset counts for the metal-on-metal groups compared with each control group (p-values ranging between 0.024 and 0.046). Statistical modelling with analysis of covariance using age, gender, type of hip replacement, smoking and circulating metal ion levels, showed that circulating levels of metal ions, especially cobalt, explained the variation in absolute lymphocyte counts for almost all lymphocyte subsets

Summary. Anatomical variations in hip joint anatomy are associated with both the presence and location of tibiofemoral osteoarthritis (OA). Introduction. Variations in hip joint anatomy can alter the moment-generating capacity of the hip abductor muscles, possibly leading to changes in the magnitude and direction of ground reaction force and altered loading at the knee. Through analysis of full-limb anteroposterior radiographs, this study explored the hypothesis that knees with lateral and medial knee OA demonstrate hip geometry that differs from that of control knees without OA. Patients and Methods. This cross-sectional study is an ancillary to the Multicenter Osteoarthritis Study (MOST), an observational cohort study of incident and progressive knee OA in community-dwelling men and women, ages 50–79 years. We report on 160 knees with lateral OA (LOA), 168 knees with medial OA (MOA), and 336 controls. All participants with LOA at the baseline MOST visit were included. An equal number of knees with MOA, and twice the number of control knees were then randomly selected. In participants with bilateral eligibility, a single knee was randomly selected so that all participants contributed only one case or one control knee to the analysis. Case knees were identified as having Kellgren/Lawrence (K/L) ≥ 2 with joint space narrowing (JSN) ≥ 1 in the specified compartment with no JSN in the adjoining compartment. Controls had no radiographic OA (K/L=0 or 1 and JSN=0) in either compartment. Hip joint anatomy parameters were assessed from full-limb standing radiographs using custom OsiriX software by an author (AB) blinded to knee OA status, and unreadable radiographs (N = 8) were discarded prior to unblinding. We measured parameters that influence the abductor moment arm of the hip, including: abductor lever arm, femoral offset, femoral neck length, femoral neck-shaft angle, height of hip centre, body weight lever arm, acetabular version, and abductor angle. All hip measurements were taken from the ipsilateral side of the knee in interest. Each variable was then compared independently among the three groups via analysis of covariance (ANCOVA), controlling for age, sex, and body mass index (BMI), and followed up with a post-hoc Bonferroni analysis to distinguish pairwise group differences. Results. The ANCOVA analysis showed a significant difference in height of hip centre (p=0.001), femoral neck-shaft angle (p=0.009), and abductor angle (p=0.001). Compared to controls, knees with LOA had an increased height of hip centre (p=0.001) and knees with MOA had a decreased abductor angle (p=0.046). Compared to knees with MOA, those with LOA had a more valgus neck-shaft angle (p=0.007) and increased abductor angle (p=0.001). Conclusion. Our study demonstrates that variations in hip geometry that affect the moment-generating capacity of the hip abductors are associated with the presence and compartmental distribution of tibiofemoral OA in the ipsilateral knee. Anatomical arrangements that reduce the hip abductor moment arm are more strongly associated with LOA than with MOA

The metal on metal implants was introduced without the proper stepwise introduction. The ASR resurfacing hip arthroplasty (RHA) withdrawn due to high clinical failure rates and the large diameter head THA (LDH-THA) are also widely abandoned. Early (2 year) radiostereometry studies does not support early instability as cause of failure but more likely metal wear products. A possible advantage may be maintenance of bone mineral density (BMD). We present 5 year prospective follow up from a randomized series, aiming to report changes from baseline and to investigate links between implant micromotion, Cr & Co ions and BMD. Patients eligible for an artificial hip were randomized to RHA, Biomet LDH-THA or standard Biometric THA. 19, 17 and 15 patients completed 5 year follow-up. All followed with BMD of the femur, acetabulum and for RHA the collum. RHA and THA with whole blood Co and Co. LDH-THA only at 5 year. RHA had marker based RSA of both components, cup only for LDH-THA. Translations were compiled to total translation (TT= √(x. 2. +y. 2. +z. 2. )). Data were collected at baseline, 8 weeks, 6 months, 1, 2 and 5 years. Statistical tests: ANCOVA for TT movement, Spearman's correlation for BMD, Cr, Co and BMI to TT at 5 years. RSA: The 5 year median (25%to75%) RHA cup translations were X=-0.00(−0.49 to 0.19) Y=0.15(−0.03 to 0.20), z=0.24(−0.42 to 0.37) and TT 0.58 (0.16 to 1.82) mm. For the LDH-THA X=−0.33(−0.90 to 0.20) Y=0.28(0.02 to 0.54), z=0.43(−1.12 to −0.19) and TT 1.06 (0.97 to 1.72) mm. The TT was statistically different (p<0.05) for the two cups. The RHA femoral component moved X=0.37(0.21 to 0.56) Y=0.02(−0.07 to 0.11), z=-0.01(−0.07 to 0.26) and TT 0.48 (0.29 to 0.60) mm at 5 years. There was no TT movement from year 2. The mean (SD) acetabular BMD was diminished to 93(90–97)% for RHA and 97(93–99.9)% for THA, but LDH-THA maintained 99(95–103)%. Overall femoral BMD was unchanged at 5 years for all interventions, but both stemmed implants lost 17% at the calcar. Median (25%to75%) whole-blood Cr peaked in the LDH-THA group with 1.7 (0.9 to 3.1) followed by RHA 1.2 (0.8 to 5.0) and THA with 0.5 (0.4 to 0.7)ppb. For Co the highest levels were found in RHA with 1.6(0.8 to 4.7) followed by LDH-THA 1.2 (0.7–1.7) and THA 0.2 (0.2 to 0.6) ppb. The only correlations above +/−0.3 for TT were the RHA femoral component with a correlation of 0.47 to BMI, 0.30 to Co and Cr. The ASR cup conversely had a negative correlation of −0.60 to BMI and again, the LDH-THA cup had a negative correlation of −0.37 to Cr. In contrast to registered revision rates, we found significantly larger movement for the Biomet cup than the ASR cup. The metal ion levels were similar. The LDH-THA cup maintained the acetabular BMD best at 5 years, but the difference was small, we are limited by small numbers and the correlations between TT and the covariates showed no clear pattern

Summary Statement. This project proves that Patellofemoral (PF) joint degeneration is not a contraindication to medial unicompartmental knee replacement. Introduction. Unicompartmental knee arthroplasty (UKA) is a recognised procedure for treatment of medial compartment osteoarthritis. Patellofemoral (PF) joint degeneration is widely considered to be a contraindication to medial unicompartmental knee replacement. We examined the validity of this preconception using information gathered prospectively on consecutive patients who underwent UKA using the Repicci II® UKA prosthesis for medial compartment osteoarthritis. Methods. We prospectively collected data on 147 consecutive patients who underwent the Repicci II® UKA for medial compartment osteoarthritis. All operations were performed between July 1999 and September 2000 by the same surgeon. The status of the PF joint was assessed intra-operatively in all patients, and accordingly patients were divided into two groups, one group with a normal PF joint, and the second group with degenerative changes of the PF joint. Variables measured for outcome included the International Knee Society (IKS) score, limb alignment, and range of motion. Radiographs were assessed for progression of disease or failure of implant. The mean follow-up was 9.4 years (range: 5–10.7 years). Patients were reviewed initially at 2 weeks, and then at 6 months post-operatively. They were subsequently reviewed on an annual basis.. All patients completed an IKS score preoperatively and at last follow-up. Age, gender, BMI, length of hospital stay, perioperative complications, all subsequent surgery, including revision of the prosthesis, and survivorship at 10 years was recorded, and results of the 2 groups compared. Results. A total of 147 patients were included in the study. None were lost to follow-up. Sixty nine had associated PF osteoarthritis (group A) while 78 patients had a normal PF compartment when assessed intra-operatively (group B). Post-operative outcomes of the two groups were compared using the ANCOVA analysis with adjustment for pre-operation values firstly, and adjusting also for gender, age, BMI and follow-up secondly. There were no significant differences in terms of IKS, alignment, and flexion between the two groups. However, patients in group B had significantly better extension post-operatively than patients in group A (p<0.05). Conclusion. We concluded that damage to the articular cartilage of the patellofemoral joint to the extent of full-thickness cartilage loss is not a contraindication to the Repicci II® unicondylar knee arthroplasty for medial compartment osteoarthritis. However, extension is significantly improved post-operatively in those patients with minimal or no PF joint degenerative disease

Summary. Analysis of existing data of patients who had undergone debridement procedure for osteoarthritis (OA) of glenohumeral joint showed improvement in disability at a minimum of one year following surgery. Injured workers were significantly younger and had a poorer outcome. Introduction. There is little information on debridement for OA of the shoulder joint. The purpose of this study was to examine factors that affect the outcome of arthroscopic debridement with or without acromioplasty /resection of clavicle of patients with osteoarthritis of the glenohumeral joint, in subjective perception of disability and functional range of motion and strength at a minimum of one year following surgery. Patients and Methods. Existing data of patients with advanced OA of the glenohumeral joint who had undergone debridement were used for analysis. These patients were not good candidates for shoulder arthroplasty due to a young age, high activity level, or desire to avoid major surgery at the time of assessment. Arthroscopic debridement included removal of loose bodies, chondral flaps, and degenerative tissue. Resection of the lateral end of the clavicle or acromioplasty was performed as clinically indicated for management of osteoarthritis of the Acromioclavicular (AC) joint or subacromial impingement respectively. Disability at a minimum of 12 months following surgery was measured by the American Shoulder and Elbow Surgeon's (ASES) assessment form, Constant-Murley score (CMS), strength, and painfree range of motion (ROM) in four directions. Impact of sex, age, having acromioplasty or resection of clavicle, and having an active work-related compensation claim was examined. Results. Seventy-four patients (mean age= 55, SD: 14 (range: 25–88), range: 35–86, 34 females, 40 males) were included in analysis. The average symptom duration was 5.8 years. Fifty nine (80%) patients had an associated subacromial decompression [55 (74%) had acromioplasty, 32(43%) had resection of the lateral end of the clavicle, and 28 (38%) had both procedures]. Nineteen (26%) patients had a work-related compensation claim related to their shoulder. This group was significantly younger than the non-compensation group (45 vs. 58, p=0.0001). Paired student t-tests showed a statistically significant improvement in scores of ASES and CMS (p<0.0001), strength (p=0.001) and painfree range of motion (p=0.01) at a minimum of 1 year follow-up. The ANCOVA model that incorporated sex, age, additional decompression (AC resection or acromioplasty), compensation claim and pre-op scores, showed that the pre-op scores and having a work-related claim were the most influential predictors of post-op scores of ASES, CMS, and ROM. The post-op strength was the only factor that was affected by sex, age and having a work-related claim. Discussion/Conclusion. Arthroscopic debridement with or without acromioplasty /resection of the lateral end of the clavicle improved disability, painfree range of motion and strength in patients suffering from osteoarthritis of glenohumeral joint at a minimum of one year following surgery. Patients with an active compensation claim related to their shoulder were significantly younger and had a poorer outcome

The role of vacuum mixing on the reduction of porosity and on the clinical performance of cemented total hip replacements remains uncertain. We have used paired femoral constructs prepared with either hand-mixed or vacuum-mixed cement in a cadaver model which simulated intra-operative conditions during cementing of the femoral component. After the cement had cured, the distribution of its porosity was determined, as was the strength of the cement-stem and cement-bone interfaces.

The overall fraction of the pore area was similar for both hand-mixed and vacuum-mixed cement (hand 6%; vacuum 5.7%; paired t-test, p = 0.187). The linear pore fractions at the interfaces were also similar for the two techniques. The pore number-density was much higher for the hand-mixed cement (paired t-test, p = 0.0013). The strength of the cement-stem interface was greater with the hand-mixed cement (paired t-test, p = 0.0005), while the strength of the cement-bone interface was not affected by the conditions of mixing (paired t-test, p = 0.275). The reduction in porosity with vacuum mixing did not affect the porosity of the mantle, but the distribution of the porosity can be affected by the technique of mixing used.