High patient satisfaction with Customized Total Knee Arthroplasty at five year follow-up.

PURPOSE: Despite numerous studies demonstrating promising short-term outcomes of Total Knee Arthroplasty (TKA) with Customized Individually Made (CIM) implants, there is a significant lack of data on their mid-term effectiveness. Given the increasing number of TKAs performed annually, the rising demand for CIM implants, and the associated burden of revision surgeries, understanding the mid-term performance of CIM implants is crucial. Therefore, this study aims to report on the mid-term (minimum 5 years) outcomes of TKA using a CIM implant. METHODS: This retrospective cohort study included a consecutive series of 116 patients who received the ConforMIS® iTotal CR implant between 2015 and 2018. Inclusion criteria were end-stage knee osteoarthritis with coronal deformities below 10° and absence of ligamentous instability. Exclusion criteria included simultaneous bilateral TKA. Patients were followed up at a minimum of five years post-surgery. They completed a questionnaire reporting on satisfaction, pain levels using the Visual Analogue Scale (VAS), current weight, the Oxford Knee Score (OKS), and the Forgotten Joint Score for the knee (FJS-knee). Statistical analysis included descriptive statistics for demographic and clinical variables, and outcomes were reported as means with ranges. RESULTS: The mean follow-up duration was 5.9 ± 0.8 years (range 5-7.4 years). 90% of patients stated they would undergo the same operation again, and 93% were either satisfied or very satisfied. The mean VAS for pain at rest was 2 ± 1.5 (range 0-6) and during exercise was 3 ± 2 (range 0-8). 58 patients (53%) managed to lose weight. The mean OKS was 41 ± 9 points (range 15-48), and the mean FJS-knee was 67 ± 23 points (range 4-100). No severe complications occurred. CONCLUSION: CIM TKA using the ConforMIS® iTotal CR implant can achieve excellent results with 93% of patients being satisfied or very satisfied at mid-term follow-up of five years. Prospective, randomized, and patient-blinded trials comparing off-the-shelf (OTS) TKAs with CIM implants are necessary to evaluate whether these implants are superior or not.

Validation of the hip disability osteoarthritis outcome Score-12 shortform in a German cohort.

INTRODUCTION: To consider the inherent respondent burden of PROMs, the HOOS-12 as a shortform of the well-established HOOS questionnaire has been published. While the HOOS-12 has been validated in an initial study, further evaluation in other, non-English speaking cohorts is necessary. We therefore aimed to evaluate responsiveness, convergent construct validity, internal consistency, and floor and ceiling effects of the HOOS-12 in a cross-sectoral german cohort. MATERIALS AND METHODS: European Quality of Life 5 Dimensions scores and HOOS data of patients undergoing total hip arthroplasty (THA) were used for the analyses. HOOS-12 scores were calculated from the full length HOOS. Statistical analysis was conducted, investigating internal consistency, floor and ceiling effects, convergent and discriminant validity, responsiveness, and known-group comparisons. RESULTS: A ceiling effect was present for postoperative HOOS-12 score and its pain, function and QoL subscales. Internal consistency was high between baseline and all follow ups, inter-item correlation was high (Cronbach's alpha > 0.30) for HOOS-12 score and all subscales. Correlation of HOOS-12 pain with HOOS pain was high (r = 0.9). Correlation of HOOS-12 function with HOOS ADL and HOOS S/R was high (r = 0.89, r = 0.74). Correlation was moderate between HOOS-12 pain and HOOS-12 function with its respective EQ-5D score (r=-0.58, r=-0.59). CONCLUSION: The HOOS-12 showed good convergent construct validity and is responsive to changes in pain, function, QoL and hip impact between preoperatively and 1 year postoperatively. A substantial ceiling effect for all subscales at 1 year postoperatively limits the ability to capture variance across particularly well performing patients. TRIAL REGISTRATION: The Trial is registered with the German Clinical Trials Register ( https://www.drks.de ; DRKS00013972; 23 March 23, 2018).

An isoelastic monoblock cup versus a modular metal-back cup: a matched-pair analysis of clinical and radiological results using Einzel-Bild-Röntgen-Analyse software.

INTRODUCTION: Bone preservation and long-term survival are the main challenges in cementless total hip arthroplasty (THA). A good bone stock is especially important for adequate anchorage of the cup in revision cases. However, the optimal acetabular cup design for preserving good bone stock is still unclear. We aimed to compare clinical outcome, radiological alterations, migration, and wear at mid-term for two different cup types. MATERIALS AND METHODS: This retrospective matched-pair study was performed using the data for 98 THA cases treated with a monoblock cup composed of vitamin E-blended highly cross-linked polyethylene (VEPE; monoblock group) or a modular cup composed of a highly cross-linked polyethylene (HXLPE) without an antioxidant (modular group). Clinical results were evaluated using the Harris Hip Score (HHS). The obtained radiographs were analyzed for radiological alterations, migration, and wear using Einzel-Bild-Röntgen-Analyse (EBRA) software. RESULTS: The mean follow-up duration was 73.2 ± 19.2 months (range: 32-108 months) and 60.5 ± 12.2 months (range: 20-84 months) in the monoblock and modular groups, respectively. HHS improved to 95.7 points in the monoblock group and 97.6 points in the modular group, without significant differences (p = 0.425). EBRA measurements were obtained in all cases. Acetabular bone alterations were not detected on radiological assessments. Mean cup migration was 1.67 ± 0.92 mm (range: 0.46-3.94 mm) and 1.24 ± 0.87 mm (range: 0.22-3.62 mm) in the monoblock and modular groups. The mean wear rate was 0.21 ± 0.18 mm (range: 0.00-0.70 mm) and 0.20 ± 0.13 mm (range: 0.00-0.50 mm) in the monoblock and modular groups. Both migration and wear pattern showed no significant differences (p = 0.741 and 0.243). None of the cases required revision surgery, yielding an implant survival rate of 100% in both groups. CONCLUSION: The isoelastic press-fit monoblock VEPE cup and modular metal-back HXLPE cup showed equivalent mid-term wear and cup migration. Long-term studies are required to determine the effects of modularity, isoelasticity, and polyethylene stabilization with vitamin E on cup loosening and survival rates.

Optimism and pessimism are antithetically associated with post-operative knee function in patients' undergoing total knee arthroplasty.

PURPOSE: Personality traits, such as dispositional optimism and pessimism, have impact on a variety of health-related problems. Influence on outcome in total knee arthroplasty (TKA) could only be shown for other personality trait concepts, but not for dispositional optimism/pessimism. This study aims to examine the association of dispositional optimism/pessimism with pre-operative joint function and post-operative outcome in TKA. METHODS: Data were acquired in a multicentre, cross-sectoral, prospective study (the PROMISE Trial). Patients were followed for 12 months post-operatively. Dispositional optimism/pessimism was measured pre-operatively via the revised Life Orientation Test (LOT-R), pre- and post-operative function was measured via the 12 Item Knee-osteoarthritis outcome Scores (KOOS-12). Log-linear regression models considering known confounders and t-test were carried out to show the association of LOT-R scores with pre- and post-operative KOOS-12 scores. RESULTS: 740 patients were analyzed. Optimistic LOT-R was significantly positively associated to the mean scores of KOOS-12 pre- and post-operative, while pessimistic LOT-R was significantly associated negatively (pre-operative: optimistic p = 0.001, pessimistic p = 0.001; post-operative optimistic: 3M p = 0.001, 6M p = 0.001, 12M p = 0.001; post-operative pessimistic: 3M p = 0.01, 6M p = 0.004, 12M p = 0.001). CONCLUSION: Optimism was positively associated with pre-operative joint function and, more importantly, post-operative functional outcome in TKA, while pessimism was associated with the opposite. Assessing patients' general personality traits prior to surgery to identify pessimistic patients, hence being at risk for poor outcome in TKA, should be considered to react to the patients' special needs and possible pessimistic expectations, i.e., through a cognitive-behavioral intervention, to potentially increase optimism and hereby post-operative outcome in TKA. LEVEL OF EVIDENCE: Prognostic Level III.

The INDICATE Knee expectations survey detects general patient treatment goals for total knee arthroplasty and the influence of demographic factors on patients expectations.

PURPOSE: Post-operative outcome after total knee arthroplasty (TKA) in the treatment of end-stage osteoarthritis correlates strongly with pre-operative impairment-driven patient treatment goals. However, a clinical tool for measuring patient treatment goals in correlation to impairments is still missing, which impedes patient-oriented indication in TKA. METHODS: Patients scheduled for TKA were recruited in four German hospitals. All patients were handed the INDICATE Knee Score pre-operatively. The score contains 31 treatment goals with respective impairments, subdivided into seven categories. They were asked to rank all treatment goals and impairments on a 3-point scale. Treatment goals and impairments were then checked for frequency of occurrence. Correlation of goal and impairment was tested. Analysis for associations of treatment goals and different cohort characteristics (age, sex, BMI) was conducted. RESULTS: 1.298 patients were included in the study. Seven treatment goals were categorised as "main goal" from more than 90% of all patients ("knee pain", "range of motion", "walking distance", "overall physical function", "climbing stairs", "quality of life", "implant survival"). Comparing age groups, there were significant associations towards higher expectations regarding working, physical and sports related treatment goals in younger patients (< 65y) ("ability to work" (P ≤ .001), "sports activities" (P ≤ .001), "sex life" (P ≤ .001), "dependence on help of others" (P = .015), "preventing secondary impairment" (P = .03), "dependence on walking aids" (P = .005)). Higher BMI resulted in increasing relevance of "weight reduction" (P ≤ .001), "climbing stairs" (P = .039) "global health status" (P = .015) and "long standing" (P = .007) as a "main goal". Analysis for differences in treatment goals regarding sex showed women choosing more treatment goals as "main goals" than men. CONCLUSION: Seven treatment goals which were expected by > 90% in our collective can be classified as general treatment goals for TKA. Demographic factors (age, sex, BMI) were significantly associated with patients' expectations for TKA. We conclude physicians should clearly assess their patients' demands prior to TKA to maximise post-operative outcome. LEVEL OF EVIDENCE: Prognostic Level III.

Simultaneous bilateral TKA in the context of fast track surgery - Do patients meet discharge criteria as anticipated?

BACKGROUND: The efficacy and safety of enhanced recovery after surgery (ERAS) protocols for patients undergoing total knee arthroplasty (TKA) have been generally proven. Previous studies investigating patients undergoing simultaneous bilateral TKA (SBTKA) focused on complications, mortality, and pain and did not examine patients' functional limitations. Therefore, the aim of this study was to investigate to what extent patients undergoing SBTKA are able to meet functional discharge criteria originally designed for their counterparts undergoing unilateral TKA (UTKA) in an ERAS setting. MATERIALS AND METHODS: All patients who received primary SBTKA between June 2015 and December 2018 were included in this retrospective analysis. For comparison, UTKA patients were matched 1:1 to SBTKA patients using Propensity Score Matching based on age, gender, and BMI. The times to achieving the rehabilitation checkpoints of walking 150 m, walking a flight of stairs, and 90° knee flexion were evaluated. RESULTS: 63 (SBTKA group) and 64 (UTKA group) patients were included. Due to the Propensity-Score-Matching there were no differences regarding age, gender, and BMI. The mean length of stay (LOS) was 9.1 days in the SBTKA and 7.6 days in the UTKA group (p = 0.003). On average, it took SBTKA patients 5.4 days to achieve an uninterrupted walking distance of at least 150 m, while it took UTKA patients 4.1 days (p < 0.001). Mean time to walking a flight of stairs was 6.3 days for SBTKA patients and 4.7 days for UTKA patients (p < 0.001). 90° flexion was achieved after 4.1 days by SBTKA patients and 3.5 days by UTKA patients (p = 0.241). CONCLUSION: The vast majority of SBTKA patients were able to achieve functional discharge criteria within their inpatient stay when allowed about 30% extra time. Therefore, functional discharge criteria in ERAS protocols designed for UTKA can be considered appropriate for SBTKA patients. LEVEL OF EVIDENCE: Therapeutic Level III.

[Disproportionately increased incidence of proximal femoral fractures in a level one trauma center : Epidemiological analysis from 2016 to 2022]. / Überproportional angestiegene Inzidenz proximaler Femurfrakturen in einem Level-One-Traumazentrum : Epidemiologische Analyse von 2016 bis 2022.

BACKGROUND: Proximal femoral fractures represent the most frequent fracture entity in Germany accounting for more than 20% of all fractures. According to a decision of the Federal Joint Committee from 2019, proximal femoral fractures also have to be surgically treated within 24 h. In order to quantify a subjectively perceived increase in workload in trauma surgery at a supraregional trauma center, a retrospective analysis of the number of surgically treated proximal femoral fractures was performed. Proximal femoral fractures were chosen due to their high incidence and homogeneous treatment. METHODS: Using ICD-10 codes, all surgically treated proximal femoral fractures from 2016 to 2022, including the patient's zip code, were retrieved from the database of the trauma center. RESULTS: The number of surgically treated proximal femoral fractures doubled from 2016 to 2022. The highest increase (60%) was recorded from 2020 to 2022. Heat maps show an increase in the catchment area radius as well. CONCLUSION: When compared (inter)nationally, a disproportionate increase in the amount of surgically treated proximal femoral fractures was recorded at the trauma center studied. The increase of the catchment area radius and the number of patients treated in the urban area show that less and less hospitals participate in emergency treatment. Possible explanations are a lack of resources aggravated by the recent COVID-19 pandemic and a lack of qualified personnel, interface problems between the federal states or the strict requirements of the Federal Joint Committee in the treatment of proximal femoral fractures. It must be assumed that there is a clearly increased workload for all professions involved in the trauma center investigated, although the infrastructure has remained unchanged.

Functional outcomes after intramedullary nailing (C-Nail®) of severe calcaneal fractures with mean follow-up of 36 months.

PURPOSE: Calcaneal fractures (CFs) are rare but potentially debilitating injuries. Apart from the open, far lateral or sinus tarsi approach, operative treatment can be performed minimally invasive and percutaneously with intramedullary nailing. In this study, we sought to investigate the functional outcome of severe CFs treated with the C-Nail® implant. METHODS: Twenty-two CFs (9 × Sanders III and 8 × Sanders IV), operated between 2016 and 2019, were followed up with a mean duration of 36 (± 11) months. The AOFAS score, pre- and postoperative Böhler angles, wound healing disorders, and patient-reported outcome measures (PROMs) like pain levels and return to work/sport levels were assessed. RESULTS: The mean AOFAS score was 72.0 (± 9.8). Four patients sustained wound healing disorders, yet no implant-associated surgical revision was required. Fifty percent of patients were pain-free within 1 year. Within 1 year, about 50% of the patients could return to sports, and about 80% of the patients could return to work. PROMs and functional results align with those from other implants reported in the literature. CONCLUSION: Intramedullary nailing of severe CFs with the C-Nail® implant can be considered a safe treatment alternative that yields acceptable results at mid-terms.

Bucket-Handle Meniscal Tears Might Not Be an Urgency: The Time to Meniscus Repair Does Not Seem to Affect the Mid-Term Outcome-A Retrospective Study of Sixty Tears with a Mean Follow-Up of 6 Years.

Background: Bucket-handle meniscal tears are mostly treated arthroscopically. However, there is no clear evidence as to whether the time to surgery impacts the outcome and whether or not lesions should be treated urgently. Methods: Sixty patients were interviewed about the current status of their knee with a mean follow-up of 6.1 years (SD = 3.5). Forty-one patients underwent meniscus repair, and fifteen patients received partial resections. The primary outcome was the rate of reoperation after meniscus repair. Secondary outcomes were pain at rest and during exercise, return to sports, and Tegner and Lysholm scores. Results: The average time to surgery was 14.4 days, with no significant impact of surgical timing on the rate of reoperation. Furthermore, no significant differences were found in pain levels, return to sports, or Tegner and Lysholm scores based on the timing of surgery. Conclusions: In our cohort, the time to surgery was not a prognostic factor for the reoperation rate or postoperative outcome in repairing bucket-handle meniscal tears. Therefore, arthroscopic repair should not be performed in an emergency setting but conducted after careful planning by experienced arthroscopy surgeons. Regarding the return to sports, postoperative factors such as rehabilitation protocols or surgical techniques could be more important than the time to surgery.

The Controversial Definition of Normal Toe Alignment.

"Normal" and "abnormal" are frequently used in surgical planning and to evaluate surgical results of the forefoot. However, there is no objectifiable value of metatarsophalangeal angles (MTPAs) 2-5 in the dorsoplantar (DP) view with which to objectively evaluate lesser toe alignment. We aimed to determine which angles are considered to be "normal" by orthopedic surgeons and radiologists. Thirty anonymized radiographs of feet were submitted twice in randomized order to determine the respective MTPAs 2-5. After six weeks, the anonymized radiographs and photographs of the same feet without apparent affiliation were presented again. The terms "normal," "borderline normal," and "abnormal" were assigned by the observers. Viewers considered MTP-2 alignment from 0° to -20° to be normal, and below -30° abnormal; MTP-3, 0° to -15° to be normal and below -30° abnormal; MTP-4, 0° to -10° normal and below -20° abnormal. Between 5° valgus and 15° varus was the range of MTP-5 recognized as normal. High intra-observer but low interobserver reliability with overall low correlation of clinical and radiographic aspects was observed. The assessment of the terms "normal" or "abnormal" are subject to a high degree of variation. Therefore, these terms should be used cautiously.

The effect of losartan on the development of post-traumatic joint stiffness in a rat model.

Post-traumatic joint stiffness (PTJS) is accompanied by a multidimensional disturbance of joint architecture. Pharmacological approaches represent promising alternatives as the traumatic nature of current therapeutic standards may lead to PTJS' progression. Losartan is an auspicious candidate, as it has demonstrated an antifibrotic effect in other organs. Forty-eight Sprague Dawley rats were randomized into equally sized losartan or control groups. After a standardized knee trauma, the joint was immobilized for either 2 weeks (n = 16), 4 weeks (n = 16) or 4 weeks with re-mobilization for an additional 4 weeks (n = 16). Pharmacotherapy with losartan or placebo (30 mg/kg/day) was initiated on the day of trauma and continued for the entire course. Joint contracture was measured alongside histological and molecular biological assessments. There were no significant biomechanical changes in joint contracture over time, comparing short-term (2 weeks) with long-term losartan therapy (4 weeks). However, comparing the formation of PTJS with that of the control, there was a trend toward improvement of joint mobility of 10.5° (p 0.09) under the influence of losartan. During the re-mobilization phase, no significant effect of losartan on range of motion (ROM) was demonstrated. At a cellular level, losartan significantly reduced myofibroblast counts by up to 72 % (4 weeks, p ≤ 0.001) without effecting the capsular configuration. Differences in expression levels of profibrotic factors (TGF-ß, CTGF, Il-6) were most pronounced at week 4. The antifibrotic properties of losartan are not prominent enough to completely prevent the development of PTJS after severe joint injury.

Retrograde tibial nailing of far distal tibia fractures: a biomechanical evaluation of double- versus triple-distal interlocking.

OBJECTIVES: Retrograde tibial nailing using the Distal Tibia Nail (DTN) is a novel surgical option in the treatment of distal tibial fracture. Its unique retrograde insertion increases the range of surgical options in far distal fractures of the tibia beyond the use of plating. The aim of this study was to assess the feasibility of the DTN for far distal tibia fractures where only double rather than triple-distal locking is possible due to fracture localisation and morphology. METHODS: Six Sawbones® were instrumented with a DTN and an AO/OTA 43-A3 fracture simulated. Samples were tested in two configurations: first with distal triple locking, second with double locking by removing one distal screw. Samples were subjected to compressive (350 N, 600 N) and torsional (± 8 Nm) loads. Stiffness construct and interfragmentary movement were quantified and compared between double and triple-locking configurations. RESULTS: The removal of one distal screw resulted in a 60-70% preservation of compressive stiffness, and 90% preservation of torsional stiffness for double locking compared to triple locking. Interfragmentary movement remained minimal for both compressive and torsional loading. CONCLUSIONS: The DTN with a distal double locking can, therefore, be considered for far distal tibia fractures where nailing would be preferred over plating.

Comparison of Postoperative Coronal Leg Alignment in Customized Individually Made and Conventional Total Knee Arthroplasty.

Neutral coronal leg alignment is known to be important for postoperative outcome in total knee arthroplasty (TKA). Customized individually made implants (CIM) instrumented with patient-specific cutting guides are an innovation aiming to increase the precision and reliability of implant positioning and reconstruction of leg alignment. We aimed to compare reconstruction of the hip-knee-ankle angle (HKA) of the novel CIM system iTotal™ CR G2 (ConforMIS Inc.) to a matched cohort of the off-the-shelf (OTS) knee replacement system Vanguard™ CR (Zimmer Biomet). Retrospective analysis of postoperative coronal full-leg weight-bearing radiographs of 562 TKA (283 CIM TKA, 279 OTS TKA) was conducted. Via a medical planning software, HKA and rotation of the leg were measured in postoperative radiographs. HKA was then adjusted for rotational error, and 180° ± 3° varus/valgus was defined as the target zone HKA. Corrected postoperative HKA in the CIM group was 179.0° ± 2.8° and 179.2° ± 3.1° in the OTS group (p = 0.34). The rate of outliers, outside of the ±3° target zone, was equal in both groups (32.9%). Our analysis showed that TKA using patient-specific cutting guides and implants and OTS TKA implanted with conventional instrumentation resulted in equally satisfying restoration of the coronal leg alignment with less scattering in the CIM group.