Patients risk for mortality at 90 days after proximal femur fracture - a retrospective study in a tertiary care hospital.

BACKGROUND: Despite improving the management of proximal femur fractures (PFF) with legal requirements of timing the surgery within 24 h, mortality rates in these patients remain still high. The objective of our study was to analyze potential cofactors which might influence the mortality rate within 90 days after surgery in PFF to avoid adverse events, loss of quality of life and high rates of mortality. METHODS: In this retrospective, single-center study all patients with PFF aged 65 years and older were included. We recorded gender, age, type of fracture, surgery and anesthesia, time, comorbidities and medication as well as complications and mortality rate at 90 days. Separate logistic regression models were used to assess which parameters were associated with patients' mortality. The mortality rate was neither associated with timing, time and type of surgery nor time and type of anesthesia, but with higher age (OR 1.08 per year; 95% CI 1.034-1.128), lower BMI (OR 0.915 per kg/m2; 95% CI 0.857-0.978), higher CCI (OR 1.170 per point; 95% CI 1.018-1.345), dementia (OR 2.805; 95% CI 1.616-4.869), non-surgical complications (OR 2.276; 95% CI 1.269-4.083) and if mobilization was impossible (OR 10.493; 95% CI 3.612-30.479). RESULTS: We analyzed a total of 734 patients (age ≥ 65 years) who had a PFF in 2019 and 2020 and received surgery. 129 patients (17.6%) died until 90 days at an median age of 89.7 years (range 65-101 years). CONCLUSION: The proportion of patients who died until 90 days after surgery is still high. It is less extend influenced by surgical and anaesthesiologic factors than by patient-related factors like age or lower BMI. Physicians should be aware of the importance of avoiding adverse events and the importance of patients' mobilization to reduce mortality and improve patients' outcome.

Better Flexion but Unaffected Satisfaction After Treatment With Posterior Stabilized Versus Cruciate Retaining Total Knee Arthroplasty - 2-year Results of a Prospective, Randomized Trial.

BACKGROUND: Both the cruciate-retaining (CR) and posterior-stabilized (PS) implant systems are commonplace in modern total knee arthroplasty (TKA) practice. However, there is controversy regarding functional outcomes and survivorship. The aim of the underlying study was to evaluate differences between CR and PS TKA regarding knee function, patient-reported outcome measures (PROMs) as well as complication rates. METHODS: 140 patients with knee osteoarthritis scheduled for an unconstrained TKA were enrolled in a prospective, randomized study. Patients received either a CR or PS implant. Range of motion and PROMs (Oxford Knee Score, Knee Society Score, European Quality of Life 5 Dimensions 3 Level, University of California Los Angeles Activity scale and subjective satisfaction) were assessed prior to, 3 months, 1 and 2 years after surgery. RESULTS: We found minor differences between treatment groups regarding demographic factors. Within the PS group duration of surgery was longer (mean PS 81.4 min vs CR 76.0 min, P = .006). We observed better flexion (median PS 120.0° vs CR 115°, P = .017) and an overall better range of motion (median PS 120.0° vs CR 115.0°, P = .008) for the PS group. PROMs did not differ between groups. At 2-year follow-up there were no revisions in either cohort. Five patients needed reoperations. Three patients needed manipulation under anesthesia, 2 in the CR and one in the PS group. CONCLUSION: While PS TKA achieved a better flexion capability, PROMs were similar in CR and PS TKA. The CR implant design continues to be a reliable option for patients with an intact posterior cruciate ligament.

No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study.

BACKGROUND: Allergies against implant materials are still not fully understood. Despite controversies about its relevance, some patients need treatment with hypoallergenic implants. This study compared coated and standard total knee arthroplasty (TKA) regarding inflammatory response and patient-reported outcome measures (PROMs). METHODS: 76 patients without self-reported allergies against implant materials were included in a RCT and received a coated or standard TKA of the same cemented posterior-stabilized knee system. 73 patients completed the 3-year follow-up. Two patients died and there was one revision surgery. Serum levels of cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IFN γ, TNF α) prior to, one and three years after surgery. Furthermore, PROMs including knee function (Oxford Knee Score, Knee Society Score) and health-related quality of life (QoL, EuroQuol questionnaire) were assessed. Additionally, 8 patients with patch-test proven skin allergy against implant materials who received the coated implant were assessed similarly and compared to a matched-pair group receiving the same implant. RESULTS: There were no differences in function and QoL between the assessed groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. Cytokine patterns showed no differences between study groups at any follow-up. The allergy patients demonstrated slower functional improvement and minor differences in cytokine pattern. Yet these results were not significant. There were no differences in the matched-pair analysis. CONCLUSION: We observed no relevant increase in serum cytokine levels in any group. The inflammatory response measured seems limited, even in allergy patients. Furthermore, there were no differences between coated and standard TKA in non-allergy patients in the 3-year Follow-Up period. TRIAL REGISTRATION: The study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT03424174 on 03/17/2016.

Influence of bone density on stability in TBW.

Osteoporosis is a common disease that leads to a reduction in bone density and increases the risk of fractures. Stable surgical treatment is particularly important for these fractures. The aim of this study was to examine the influence of bone density in the area of ​​the proximal ulna on the failure of the fixation technique of K-wires in tension band wiring (TBW). We provided 10 ulna specimens with TBW and biomechanically examined the pull-out strength of bi- and tricortical K-wires. Bone density measurement was performed using qCT. In the paired t-test, the tricortical group showed a significantly higher pull-out strength in relation to bone density than the bicortical group (p = 0.001). Furthermore, the Pearson correlation showed a high influence of bone density on pull-out strength in the tricortical group (r = 0.544), but without significance (p = 0.100).Our work shows that bone density has a direct effect on the pull-out strength of K-wires in TBW. TBW should therefore be used as osteosynthesis technique, especially in young patients with non-osteoporotic bones. In the case of osteoporotic fractures, alternative procedures should be preferred.

Fulfilment of patients' mandatory expectations are crucial for satisfaction: a study amongst 352 patients after total knee arthroplasty (TKA).

PURPOSE: Patient satisfaction with the results of their total knee arthroplasty (TKA) is one of the primary goals of this elective procedure. Furthermore, the association between the fulfilment of patients' expectations and their satisfaction is well known. The aim of this study was to identify the key expectations of patients awaiting a TKA, evaluate their fulfilment, and compare the outcomes between very and not fully satisfied patients. METHODS: A prospective cohort study of patients with knee OA scheduled for primary TKA was performed. Pre- and one-year postoperatively patient-reported outcome measures (PROMs) were assessed. Expectations and their fulfilment were evaluated via a questionnaire encompassing 31 expectations. Preoperatively, expectations were indicated as mandatory, desirable and not important. Postoperatively, fulfilment was rated as exceeded, fulfilled, partially or not fulfilled, and not applicable. Satisfaction with the results of TKA was measured with a numeric rating scale (NRS) of 0-10. Discrimination between not fully satisfied and very satisfied patients was set at ≥ 8, as has been proposed recently. To identify independent predictors of this discrimination, a multivariate logistic regression analysis was performed. RESULTS: Complete data sets of 352 patients were analysed. A set of 17 key expectations was identified. Relief of knee pain was fulfilled the most, and improvement of physical function was fulfilled the least. When asked about overall fulfilled expectations, 40% of patients rated them as exceeded, 34% as fulfilled and 26% as less fulfilled than expected. Not fully satisfied patients showed significantly lower PROMs pre- and postoperatively and less fulfilled key expectations. Higher numbers of exceeded and fulfilled mandatory expectations, higher overall fulfilment and better range of motion (ROM) were significant predictors for satisfaction ≥ 8. CONCLUSION: Patients' expectations of TKA outcomes were high with equal emphasis on knee-related and general health-related aspects. Their fulfilment was positively associated with satisfaction. Surgeons should ask patients about mandatory expectations for successful TKA and counsel them about the likelihood of their fulfilment to avoid unrealistic expectations. LEVEL OF EVIDENCE: II.

Ankle fractures involving the anterolateral distal tibia: medium-term clinical results of 50 cases.

PURPOSE: The anterolateral distal tibial rim (anterior malleolus, AM) is frequently fractured in malleolar fractures. The aim of this study was to evaluate the medium-term outcomes of malleolar fractures involving the AM. METHODS: Among 100 patients with AM fractures that were treated over a 10-year period, 50 patients were available for follow-up. Outcome was assessed with the Olerud Molander Ankle Score (OMAS), the Foot Function Index (FFI-D), the EuroQol (EQ)-5D-5L Index, the EQ-VAS and the AOFAS Ankle-Hindfoot Score. Type 1 AM fractures (bony syndesmotic avulsions) were fixed surgically with either a suture anchor or a transosseous suture in 11 of 22 cases (50%). Among type 2 AM fractures (with incisura and joint involvement), 68% were treated surgically with screw fixation. All three type 3 AM fractures (anterolateral tibial plafond impaction) were treated surgically with either screw or plate fixation. RESULTS: At follow-up, the median OMAS was 75, the FFI-D 19, the EQ-5D-5L-Index 0.88, the EQ-VAS 70, and the AOFAS score 93. Assuming that the fracture severity increases from Supination-External Rotation to Pronation-External Rotation and Pronation-Abduction injuries, the AOFAS score (p < 0.001), OMAS score (p = 0.009), and FFI-D (p = 0.041) all showed a significantly inferior clinical outcome with increasing fracture severity. Patients who required surgical revision (n = 5) showed a significantly inferior outcome with the OMAS (p = 0.019). CONCLUSIONS: A differentiated treatment protocol tailored to dislocation, size, incisura involvement and joint impaction leads to favourable outcomes in complex malleolar fractures involving the AM. More data are needed on the outcome of AM fractures that are still commonly underestimated and overlooked.

Acquired Factor XIII Deficiency in Patients with Multiple Trauma.

INTRODUCTION: Fibrin stabilizing factor (FXIII) plays a crucial role in blood clotting, tissue repair, and immune defense. FXIII deficiency after trauma can lead to prolonged wound healing due to persistent infections or coagulation disorders. The aim of this study was to describe the prevalence of acquired FXIII deficiency after trauma and to provide a description of the time-course changes of important coagulation parameters in relation to FXIII activity. In this context, patient characteristics, laboratory data, and treatment modalities were examined with respect to their influence on FXIII activity. Furthermore, the effects of in vitro administration of FXIII on clot firmness and outcomes in patients with severe traumatic brain injury were investigated. PATIENTS AND METHODS: Two trauma cohorts (A and B) were examined prospectively in a two-center study, and another (cohort C) was examined retrospectively. In cohort A (trauma patients, n=880) routine laboratory tests were conducted, and FXIII activity was measured. In cohort B (polytrauma patients, n=26), additional clinical parameters were collected, and in-vitro FXIII administration and rotational thromboelastometry (ROTEM) analyses were performed. In cohort C (polytrauma patients with severe traumatic brain injury [sTBI], n=84), the impact of initially measured FXIII activity on clinical outcomes after sTBI was investigated using the modified Rankin Scale (mRS) at least 6 months after trauma. RESULTS: The prevalence of FXIII activity <70% in cohort A was 12.4%, with significant differences in age, Hb, fibrinogen, and Hct levels, platelet count, aPTT, and INR (vs. prevalence of FXIII activity >70%). Cohort B showed a decrease in FXIII activity from 85% to 58% after 7 days. FXIII deficiency correlated with time after trauma, aPTT, and fibrinogen level, lactate, and Hb levels. In-vitro administration of FXIII showed a positive influence on clot firmness due to improved maximum clot firmness (MCF in FIBTEM) and reduced maximum lysis (ML in EXTEM). Finally, a significant difference in FXIII activity between patients after sTBI with good and poor clinical outcomes was observed 6 months after trauma. CONCLUSION: We demonstrated that trauma-associated FXIII deficiency is a common coagulation disorder, with FXIII deficiency increasing further in the first 7 days after trauma, the period of early surgical care. In vitro administration of FXIII was able to demonstrate significant clot stabilizing effects. For trauma patients with sTBI, FXIII activity could serve as a prognostic parameter, as it differed significantly between patients with good and poor clinical outcomes.

Complications following surgical treatment of posterior malleolar fractures: an analysis of 300 cases.

AIMS: The treatment of ankle fractures and fracture-dislocations involving the posterior malleolus (PM) has undergone considerable changes over the past decade. The aim of our study was to identify risk factors related to the occurrence of complications in surgically treated ankle fractures with PM involvement. PATIENTS AND METHODS: We retrospectively analyzed 300 patients at a mean age of 57 years with 300 ankle fractures involving the PM treated surgically at our institution over a 12-year period. The following relevant comorbidities were noted: arterial hypertension (43.7%; n = 131), diabetes mellitus (DM) (14.0%; n = 42), thereof insulin-dependent (3.7%; n = 11), peripheral vascular disease (0.7%; n = 2), osteoporosis (12.0%; n = 36), dementia (1.0%; n = 3), and rheumatoid arthritis (2.0%; n = 6). Furthermore, nicotine consumption was recorded in 7.3% (n = 22) and alcohol abuse in 4.0% (n = 12). RESULTS: Complications occurred in 41 patients (13.7%). A total of 20 (6.7%) revision surgeries had to be performed. Patients with DM (p < 0.001), peripheral vascular disease (p = 0.003) and arterial hypertension (p = 0.001) had a significantly increased risk of delayed wound healing. Alcohol abuse was associated with a significantly higher overall complication rate (OR 3.40; 95% CI 0.97-11.83; p = 0.043), increased rates of wound healing problems (OR 11.32; 95% CI 1.94-65.60; p = 0.001) and malalignment requiring revision (p = 0.033). The presence of an open fracture was associated with an increased rate of infection and wound necrosis requiring revision (OR 14.25; 95% CI 2.39-84.84; p < 0.001). Multivariate analysis identified BMI (p = 0.028), insulin-dependent DM (p = 0.003), and staged fixation (p = 0.043) as independent risk factors for delayed wound healing. Compared to the traditional lateral approach, using the posterolateral approach for fibular fixation did not lead to increased complication rates. CONCLUSIONS: Significant risk factors for the occurrence of complications following PM fracture treatment were identified. An individually tailored treatment regimen that incorporates all risk factors is important for a good outcome.

Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty.

PURPOSE: Allergy against implant materials is discussed controversially and still not fully understood. Despite these controversies, a relevant number of patients receive hypoallergenic knee implants. The aim of this study was to compare a new coating system with the standard implant in total knee arthroplasty (TKA). Additionally, the influence of proinflammatory cytokines on patient-reported outcome measures (PROMs) was investigated. METHODS: 120 patients without known metal allergy and without previous metal implants were included. The patients were randomized to receive a coated or standard TKA of the same knee system. 105 patients completed the 5 year follow-up. Patient-reported outcome measures (PROMs) including knee function (Oxford Knee Score, OKS), quality of life (SF36) and UCLA activity scale were assessed. Additionally, several cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IP-10, IFN γ, TNF α). Group comparison was performed using Mann-Whitney U test for continuous values and chi-square test for categorical values. RESULTS: There were no differences in PROMs between both groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. The blood cytokine pattern after 5 years demonstrated no differences between study groups. There was a significant association between elevated IL-8 values and worse results in the overall OKS (p = 0.041), the OKS function component (p = 0.004), the UCLA activity scale (p = 0.007) and the physical component of SF36 (p = 0.001). CONCLUSION: There were no problems with the new coating during mid-term follow-up and no differences in PROMs between coated and standard TKA. Patients with an increased inflammatory response demonstrated worse functional results, regardless of the implant. LEVEL OF EVIDENCE: I. CLINICAL TRIAL REGISTRATION: The study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT00862511.

A Novel Multilayer-Coating for Total Knee Arthroplasty Implants is Safe - 10-Year Results From a Randomized-Controlled Trial.

BACKGROUND: This randomized-controlled trial was initiated to compare a new multilayer hypoallergenic coating system with the standard implant in total knee arthroplasty (TKA) in terms of serum metal ion levels, patient-reported outcomes (PROs), and implant survival. METHODS: A total of 120 patients were randomized to receive a coated or standard TKA of the same knee system. Serum metal ion levels (ie, cobalt, chromium, molybdenum, and nickel) as well as knee function (Oxford Knee Score, OKS), quality of life (SF-36), and physical activity (UCLA activity scale) were assessed before surgery and until the 10 year follow-up. A total of 24 patients died and there was one revision in each group. This resulted in 85 patients who completed follow-up. RESULTS: Both groups demonstrated equally good improvement in PROs after surgery and constant score values thereafter. The majority of patients had metal ion serum levels below detection limit. Only cobalt levels demonstrated a slight increase in the standard group at 5- and 10-year follow-up. However, all patients displayed values below 3 µg/L. The cumulative 10-year survival was 98% in both groups. CONCLUSION: There were no problems with the new coating system. No relevant increase in metal ion serum levels were measured. A slight increase in cobalt serum levels in the standard TKA was noted, thus not reaching critical values. The new coating system demonstrated equally good PROs as the standard TKA. Excellent implant survival was observed in both groups. LEVEL OF EVIDENCE: I.

Does the use of patient-specific instrumentation improve resource use in the operating room and outcome after total knee arthroplasty?-A multicenter study.

Patient-specific instrumentation (PSI) in total knee arthroplasty (TKA) has been introduced to reduce instruments and surgical time and to improve implant alignment. The aim of this study was to compare TKA with patient-specific and conventional instrumentation with regard to the use of resources in the operating room (OR), alignment and patient-reported outcome. A total of 139 TKA with PSI or conventional instrumentation were included in three centers. Economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed after 6 weeks, 6 and 12 months. There was a significant reduction of instrument trays and of time in the OR in the PSI group. The reduction varied between the centers. With strict reorganization, more than 50% of the instrument trays could be reduced while using PSI. There were no significant differences in cut-sew-time, implant position, leg axis, pain and function. The use of PSI was associated with significantly less OR resources. However, the savings did not compensate the costs for this technology.

Total knee arthroplasty in post-traumatic osteoarthritis is more challenging, but results in similar patient satisfaction - An analysis of 1646 cases.

BACKGROUND: Patients with post-traumatic osteoarthritis (PTOA) present a variety of technical challenges to surgeons. Surgical parameters, complication rates and patient-reported outcomes (PROs) have been reported as detrimental in total knee arthroplasty (TKA) for PTOA. The purpose of this study was to compare these variables and satisfaction with the results of TKA in patients with post-traumatic osteoarthritis with a matched-pair cohort of primary osteoarthritis (POA). METHODS: A registry-embedded prospective case-control study was performed. Of a total of 1646 TKAs, 155 were performed due to PTOA between 2012 and 2019. One-hundred and thirty-six could be one-to-one propensity score-matched to patients with POA undergoing primary TKA based on similar patient demographic variables. Outcomes investigated included operation time, estimated blood loss, types of implants, postoperative complications and PROs pre- and 1 year postoperatively as well as satisfaction with the results of surgery. Sub-cohort analysis was performed for patients with prior fracture and soft tissue trauma, respectively. RESULTS: Surgical parameters were significantly different in disadvantages of PTOA: operation time (P < 0.001), estimated blood loss (P < 0.001), blood transfusions (P = 0.039), type of implants (P < 0.001). Manipulation under anaesthesia (MUA) was necessary more often in the PTOA fracture group (odds ratio 5.01, (95% confidence interval 1.04; 24.07). PRO demonstrated no substantial differences after 1 year. Satisfaction with the results of TKA was as equally high in all cohorts. CONCLUSIONS: This study demonstrated that TKAs in patients with PTOA require higher surgical effort but can result in similar PROs and satisfaction compared to POA, regardless of the underlying trauma.

Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization.

BACKGROUND: Monteggia fractures and Monteggia-like lesions result after severe trauma and have high complication rates. Preliminary biomechanical studies suggested a correlation between ulnar fracture localization and clinical result. OBJECTIVES: Key objective was to evaluate whether the site of the ulnar fracture can be correlated to clinical outcome after open reduction and internal stabilization. METHODS: In a retrospective, monocentric study 35 patients who underwent surgical treatment after suffering a Monteggia injury or Monteggia-like lesion were included. Fractures were classified according to Bado and Jupiter, the site of the fracture location at the proximal ulna and regarding the potential accompanying ligamentary injury. In a follow-up examination validated patient-reported outcome measures and functional parameters were evaluated. Furthermore, treatment strategy and complications were analysed. RESULTS: Mean patient age was 51.9 years (± 18.0). 69% were females (n = 24). Follow-up took place after 50.5 months (± 22.1). Fractures were classified according to Bado (I:2, II:27, III:4, IV:2). Bado II-fractures were further classified according to Jupiter (A:7, B:16, C:3, D:1). Cases were divided into subgroups depending upon the distance of the ulnar fracture site in respect to its distal endpoint (A: < 7 cm and B: > 7 cm). Average overall MEPS was 84.1 (± 19.0). Oxford elbow score and DASH were 37.2 (± 10.5) and 20.4 (± 20.5). Average extension capability reached - 7° (± 7.5). Mean flexion was 134.8° (± 19.7). Average pain according to visual analogue scale was 1.6 (± 1.9). We found no differences between the subgroups regarding the PROMs. Subgroup A displayed a worse extension capability (p = 0.027) and patients were significantly older (p < 0.01). Comparing patients with and without fracture of the radial head, we observed no differences. Patients with an accompanying injury of the coronoid process displayed higher pain levels (p = 0.011), a worse functionality (p = 0.027) and overall lower scoring in PROM. CONCLUSION: The presented results suggest that in Monteggia fractures and Monteggia-like lesions, the localization of the ulna fracture can give a hint for its postoperative outcome. However, we could not confirm the hypothesis of an increasing instability in ulnar fractures located further distally (high severity of the potential ligamentous injury). Intraarticular fractures or injuries with a close relation to the joint have a worse prognosis, especially if the coronoid process is injured. Trial registration Registration was done with ClinicalTrials.gov under NCT05325268.

[The use of knee prostheses with a hypoallergenic coating is safe in the medium term : A randomized controlled study]. / Die Anwendung antiallergisch beschichteter Knieendoprothesen ist mittelfristig sicher : Eine randomisierte kontrollierte Studie.

BACKGROUND: In Germany, patients with contact allergy to implant components usually receive coated joint arthroplasties. Whether the treatment using these hypoallergenic implants achieves comparable results to standard treatment with implants consisting of cobalt-chromium alloy (CoCr) implants is controversially discussed internationally and has rarely been investigated in the mid-term. OBJECTIVES: Are there differences in blood metal ion concentrations, knee function, and patient-reported outcomes (PROM) between coated and standard implants? MATERIAL AND METHODS: 118 patients were randomized to receive either a coated or a standard implant. Knee function as well as patient-reported outcome measures were assessed. Metal ion concentrations in blood samples were additionally determined for chromium, cobalt, molybdenum, and nickel, preoperatively, one and five years after surgery. RESULTS: After five years, it was possible to analyse the results of 97 patients. In metal ion concentrations, as well as PRO, consistently good results were seen, without any difference between the groups. While in 13 patients there was an increase in chromium concentration above 2 µg/l one year after surgery, there was no measured value above 1 µg/l after five years. CONCLUSION: In our study, similar mid-term results were detected for coated (TiNiN) and standard (CoCr)TKA. With respect to metal ion concentrations and PRO there are no disadvantages in using coated TKA.

Ultracongruent insert design is a safe alternative to posterior cruciate-substituting total knee arthroplasty: 5-year results of a randomized controlled trial.

PURPOSE: If substitution of the posterior cruciate ligament in total knee arthroplasty is necessary, there are two options available: posterior stabilized (PS) design with a post-cam mechanism or anterior-lipped ultracongruent (UC) inserts. UC inserts have the advantage that no femoral box is necessary and a standard femoral component can be used. The aim of this study was to compare the range of motion (ROM) and patient-reported outcome (PRO) after UC and PS fixed-bearing TKA. Better ROM in PS TKA and no difference in PRO between both designs was hypothesized. METHODS: A randomized controlled trial with 127 patients receiving a fixed-bearing UC or PS design of the same knee system was performed. Nine patients died and there were four revision surgeries. 107 patients completed the 5-year follow-up. Patient-reported outcome was assessed. Patellofemoral problems were evaluated using selected applicable questions of the Oxford Knee Score (getting up from a table, kneeling, climbing stairs). RESULTS: Surgical time was 10 min shorter in the UC group (p < 0.001). After 5 years, both groups demonstrated good knee function and health-related quality of life without significant differences between the groups. Both groups demonstrated a high satisfaction score and the majority of patients would undergo this surgery again. Patellofemoral problems were recognized more frequently in the PS group (p = 0.025). CONCLUSION: Both designs demonstrated similar good results after 5 years. Stabilization with an anterior-lipped UC insert can be considered a safe alternative to the well-established PS design if cruciate substitution is necessary.

An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial.

BACKGROUND: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. METHODS: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. DISCUSSION: There is a high potential for transferring the intervention into routine practice if the evaluation is positive. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.

Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study.

BACKGROUND: Computer-assisted navigation (CAS) was developed to improve the surgical accuracy and precision. Many studies demonstrated better alignment in the coronal plane in CAS TKA compared to conventional technique. The influence on the functional outcome is still unclear. Only few studies report long-term results of CAS TKA. This study was initiated to investigate 10-year patient-reported outcome of CAS and conventional TKA. METHODS: From initially 80 patients of a randomized study of CAS and conventional TKA a total of 50 patients could be evaluated at the 10-year follow-up. The Knee Society Score and EuroQuol Questionnaire were assessed. For all patients a competing risk analysis for revision was performed. RESULTS: The patient-reported outcome measures demonstrated similar values for both groups. The 10-year risk for revision was 2.5% for conventional TKA and 7.5% for CAS TKA (p=0.237). CONCLUSIONS: There was no difference between CAS and conventional TKA with regard to patient-reported outcome and revision risk ten years after surgery. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov on 11/30/2009, ID: NCT01022099 .

[Are the results of total knee arthroplasty after high tibial osteotomy worse?] / Sind die Ergebnisse von Knietotalendoprothesen nach Tibiakopfumstellungsosteotomie schlechter?

BACKGROUND: In some cases, total knee arthroplasty (TKA) following high tibial osteotomy (HTO) is necessary. HTO can adversely affect anatomy and alignment resulting in more complicated and challenging TKA surgery. The aim of this study was to investigate whether patients having undergone HTO benefit from TKA to the same extent as patients with primary osteoarthritis of the knee. METHODS: A total of 44 patients after HTO and 1703 patients with primary osteoarthritis of the knee were identified in the local registry. To reduce confounders, a 1:1 propensity score matched-pair analysis (age, gender, BMI, comorbidities) was carried out in patients with a 5-year follow-up. This resulted in 35 matched pairs, which were compared for knee function, pain level, satisfaction and perioperative data (operative time, implant type, complications) and revisions. RESULTS: Patients having undergone HTO had no significant differences in knee function prior and 5 years after surgery but a significantly higher pain level. Despite the higher pain level before and after TKA, there was a similar satisfaction with the result of the surgery. The operative time for TKA was significantly longer after HTO and modular implants with stem and wedges were used significantly more often. The two cohorts did not differ with respect to complications within the first 3 months after surgery. The revision rate within 5 years was not increased in patients after HTO. CONCLUSION: Patients having undergone HTO achieved a similar knee function in comparison to patients with primary osteoarthritis of the knee after TKA. However, a higher pre- and postoperative pain level was recorded in patients following HTO. The surgical effort was significantly higher after HTO.

Better short-term function after unicompartmental compared to total knee arthroplasty.

BACKGROUND: Unicompartmental knee arthroplasty (UKA) is an established treatment option for patients with unicompartmental osteoarthritis (OA). However, strict patient selection is crucial for its success. The proposed advantages include nearly natural knee kinematics, faster rehabilitation and better functional outcomes. Despite the aforementioned facts and it's proven cost-effectiveness, there are still hesitations for the use of UKA as an alternative to total knee arthroplasty (TKA). Key objectives of this study were therefore to assess clinical and patient-reported outcome (PRO) as well as patient's satisfaction after medial UKA in comparison to TKA. METHODS: To assess the outcome after UKA we conducted a prospective multi-center study. 116 patients with unicompartmental OA and indication for UKA were included. Overall 54 females and 62 males with an average age of 62.7 years (±9.8) and an average body mass index (BMI) of 29.2 (± 3.7) were recruited. Clinical results and PRO were assessed using the Knee Society Score (KSS). Follow-ups took place 3 months, 1 and 2 years after surgery including clinical examination, radiographs, assessment of PRO and adverse events. Pain and satisfaction was evaluated using a visual analog scale (VAS, 0 (worst) to 10 (best)). For comparison with TKA a propensity score matched-pair analysis was performed to eliminate confounders. Matching criteria were gender, patient's age, BMI and comorbidities. A total of 116 matched-pairs were analysed. RESULTS: There was no revision in the UKA group until 2 years after surgery. Revision rates were higher in the TKA group (0.6%). Preoperative KSS-Scores were higher within the UKA cohort (p <  0.001). After surgical treatment, PROMs displayed a significant improvement (p <  0,001) in both cohorts. Regarding the Knee-Score (Pain, Alignment, ROM) we observed no differences between cohorts after 12 months. The Function-Score demonstrated significantly better results in the UKA cohort (UKA vs. TKA 95 vs 80, p <  0.001). Patient satisfaction was also higher in UKA patients (UKA vs TKA 9.0 vs 8.8, p = 0.019). CONCLUSION: Patients of both cohorts showed high satisfaction after knee arthroplasty. UKA resulted in higher function scores compared to TKA without increased revision rate during short-term follow-up. Therefore, UKA is a good treatment option for unicompartmental OA. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04598568 . Registered 22 October 2020 - Retrospectively registered.

Symptom Burden and Palliative Care Needs of Patients with Incurable Cancer at Diagnosis and During the Disease Course.

BACKGROUND: Although current guidelines advocate early integration of palliative care, symptom burden and palliative care needs of patients at diagnosis of incurable cancer and along the disease trajectory are understudied. MATERIAL AND METHODS: We assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer in a prospective longitudinal observational multicenter study. Patients were evaluated using validated self-report measures (National Comprehensive Cancer Network Distress Thermometer [DT], Functional Assessment of Cancer Therapy [FACT], Schedule for the Evaluation of Individual Quality of Life [SEIQoL-Q], Patients Health Questionnaire-4 [PHQ-4], modified Supportive Care Needs Survey [SCNS-SF-34]) at baseline (T0) and at 3 (T1), 6 (T2), and 12 months (T3) follow-up. RESULTS: From October 2014 to October 2016, 500 patients (219 women, 281 men; mean age 64.2 years) were recruited at 20 study sites in Germany following diagnosis of incurable metastatic, locally advanced, or recurrent lung (217), gastrointestinal (156), head and neck (55), gynecological (57), and skin (15) cancer. Patients reported significant distress (DT score ≥ 5) after diagnosis, which significantly decreased over time (T0: 67.2%, T1: 51.7%, T2: 47.9%, T3: 48.7%). The spectrum of reported symptoms was broad, with considerable variety between and within the cancer groups. Anxiety and depressiveness were most prevalent early in the disease course (T0: 30.8%, T1: 20.1%, T2: 14.7%, T3: 16.9%). The number of patients reporting unmet supportive care needs decreased over time (T0: 71.8 %, T1: 61.6%, T2: 58.1%, T3: 55.3%). CONCLUSION: Our study confirms a variable and mostly high symptom burden at the time of diagnosis of incurable cancer, suggesting early screening by using standardized tools and underlining the usefulness of early palliative care. IMPLICATIONS FOR PRACTICE: A better understanding of symptom burden and palliative care needs of patients with newly diagnosed incurable cancer may guide clinical practice and help to improve the quality of palliative care services. The results of this study provide important information for establishing palliative care programs and related guidelines. Distress, symptom burden, and the need for support vary and are often high at the time of diagnosis. These findings underscore the need for implementation of symptom screening as well as early palliative care services, starting at the time of diagnosis of incurable cancer and tailored according to patients' needs.