Custom total knee arthroplasty with personalised alignment showed better 2-year functional outcome compared to off-the-shelf arthroplasty.

PURPOSE: Customised individually made (CIM) total knee arthroplasty (TKA) with personalised alignment is relatively new and evidence is limited. The aim of this study was to compare patient-reported outcome measures between CIM and off-the-shelf (OTS) TKA patients in a matched-pair analysis with a 2-year follow-up. METHODS: In this single-centre, prospective cohort study, propensity score matching was performed on 51 CIM and 51 OTS TKA. Data were measured at baseline, at 4 months, 1 and 2 years and included the Forgotten Joint Score (FJS-12), the High Activity Arthroplasty Score (HAAS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the EQ-5D-3L, the EQ-Visual Analogue Scale, satisfaction, overall knee improvement, willingness to undergo the surgery again and the Knee Society Score. RESULTS: At 2 years follow-up, the FJS-12 (77 vs. 67, p = .058), HAAS (13 vs. 11, p < .001), KOOS daily living (92 vs. 86, p = .029), KOOS sport (76 vs. 65, p = .019), KOOS quality of life (81 vs. 71, p = .028) and the EQ-5D (.95 vs. .90, p = .030) were higher for CIM TKA compared to OTS TKA. Satisfaction rate was 92% for CIM TKA and 84% for OTS TKA (p = .357). Most patients reported an improvement in the overall knee state (94% CIM and 90% OTS, p = .487) and almost all patients would undergo the surgery again (96% CIM and 98% OTS, p = .999). CONCLUSION: The current study found that CIM TKA patients had better functional outcomes at 2 years. Patient satisfaction was high and not statistically significantly different from OTS TKA patients. LEVEL OF EVIDENCE: Level II prospective cohort study.

High Expectations Among Patients Who Have Undergone TKA Do Not Correlate With Satisfaction.

BACKGROUND: One of five patients is dissatisfied with the outcome of TKA. With the increasing number of TKAs, this affects many patients. It has been suggested that high expectations may influence satisfaction, but the relationship between preoperative patient expectations and postoperative patient satisfaction remains poorly understood. QUESTIONS/PURPOSES: (1) Are preoperative patient expectations correlated with postoperative satisfaction? (2) Are expectations correlated with patient characteristics or patient-reported outcome measures (PROMs)? (3) Is satisfaction correlated with patient characteristics or PROMs? (4) Do patients report specific items as more relevant to their expectations? METHODS: This was a single-center, observational, retrospective, comparative study involving patients who underwent TKA. Between December 2020 and June 2022, three senior surgeons performed 306 TKAs. Of these, 76% (234) had the preoperative PROMs required for this study, and of these, 82% (193) had completed PROMs at the 12-month follow-up interval and were analyzed. Of the 193 included patients, 53% (102) were women; the mean age was 68 ± 9 years. Data were collected at baseline, 4 months, and 12 months. Twelve months of follow-up has been shown to be adequate in studies with PROMs. Patient expectations were measured using the validated Hospital for Special Surgery Knee Replacement Expectation Survey on a scale from 0 to 100, with higher scores indicating higher expectations. We also assessed patient satisfaction, the Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, High-Activity Arthroplasty Score, EQ-5D-3L, and the objective Knee Society Score. Bivariate linear correlations were analyzed using the Pearson or Spearman test. RESULTS: Preoperative patient expectations did not correlate with postoperative satisfaction. The mean Hospital for Special Surgery Knee Replacement Expectation Survey score was 82 ±16 points and did not correlate with satisfaction at either 4 months (r = -0.061; p = 0.42) or 12 months (r = -0.126; p = 0.11). Expectations did not correlate with patient characteristics or any of the preoperative or postoperative PROMs or the Knee Society Score. Patient satisfaction was 88% (158 of 179) at 4 months and 83% (160 of 193) at 12 months and did not correlate with patient characteristics or any of the preoperative PROMs or Knee Society Score. Patient satisfaction was medium to strongly correlated with postoperative PROMs and Knee Society Score. The Hospital for Special Surgery Knee Replacement Expectation Survey items with the most frequent expected improvement were "ability to walk" (99% [192 of 193]), "go downstairs" (99% [191 of 192]), and "go upstairs" (99% [192 of 193]). CONCLUSION: Preoperative expectations were not correlated with postoperative satisfaction or PROMs. Surgeons should be aware that patients have high expectations. However, these expectations appear to be less relevant in determining postoperative satisfaction. LEVEL OF EVIDENCE: Level III, therapeutic study.

Comparison of Responsiveness of Patient-Reported Outcome Measures After Total Knee Arthroplasty.

BACKGROUND: The aim of this study was to evaluate the responsiveness of different patient-reported outcome measures in patients with primary total knee arthroplasty (TKA). METHODS: In this prospective observational study, we assessed patients with TKA before the surgery, after 4 months, after 1 year, and after 2 years. Measures were the objective Knee Society Score (KSS) and the following patient-reported outcome measures: Knee injury and Osteoarthritis Outcome Score (KOOS), KOOS-12, Forgotten Joint Score (FJS-12), High-Activity Arthroplasty Score, and EQ-5D-3L. Responsiveness was determined by effect size (ES), standardized response mean (SRM), area under the receiver operating characteristics curve, floor and ceiling effects, and hypothesis testing. RESULTS: We analyzed data from 309 TKAs (272 patients, 56% female). The ES and SRM for the change in KSS, KOOS, KOOS-12, FJS-12, and EQ-5D-3L from baseline to each follow-up were large (>0.8). The largest responsiveness from baseline to follow-up was found for the KSS, KOOS/KOOS-12 quality of life, KOOS-12 summary, KOOS-12 pain, and FJS-12 (2.0 > ES <3.9, 1.4 > SRM <2.4). The area under the curve from baseline to each follow-up was ≥0.7 for KOOS, KOOS-12, and FJS-12 (range 0.71 to 0.95) and <0.7 for KSS and EQ-5D-3L (range 0.65 to 0.74). We found floor or ceiling effects in the KOOS, KOOS-12, and EQ-5D-3L, but not in the KSS, FJS-12, and High-Activity Arthroplasty Score. CONCLUSIONS: Our study demonstrated that responsiveness differed between the various measures. The KOOS-12 and FJS-12 showed the greatest internal and external responsiveness, although ceiling effects occurred in the KOOS-12.

Satisfaction after total knee arthroplasty: a prospective matched-pair analysis of patients with customised individually made and off-the-shelf implants.

PURPOSE: Customised individually made (CIM) total knee arthroplasty (TKA) was introduced to potentially improve patient satisfaction and other patient-reported outcome measures (PROMs). The purpose of this study was to compare PROMs, especially patient satisfaction, of patients with CIM and OTS TKA in a matched-pair analysis with a 2-year follow-up. METHODS: This is a prospective cohort study with a propensity score matching of 85 CIM and 85 off-the-shelf (OTS) TKA. Follow-up was at 4 months, 1 year and 2 years. The primary outcome was patient satisfaction. Secondary outcomes were as follows: overall improvement, willingness to undergo the surgery again, Knee injury and Osteoarthritis Outcome Score (KOOS), Forgotten Joint Score (FJS-12), High-Activity Arthroplasty Score (HAAS), EQ-5D-3L, EQ-VAS, Knee Society Score (KSS) and surgeon satisfaction. RESULTS: Patient satisfaction ranged from 86 to 90% and did not differ between CIM and OTS TKA. The EQ-VAS after 4 months and the HAAS after 1 year and 2 years were higher for CIM TKA. KOOS, FJS-12 and EQ-5D-3L were not different at follow-up. The changes in KOOS symptoms, pain and daily living were higher for OTS TKA. The KSS was higher for patients with CIM TKA. Surgeon satisfaction was high throughout both groups. Patients who were satisfied after 2 years did not differ preoperatively from those who were not satisfied. Postoperatively, all PROMs were better for satisfied patients. Patient satisfaction was not correlated with patient characteristics, implant or preoperative PROMs, and medium to strongly correlated with postoperative PROMs. CONCLUSION: Patient satisfaction was high with no differences between patients with CIM and OTS TKA. Both implant systems improved function, pain and health-related quality of life. Patients with CIM TKA showed superior results in demanding activities as measured by the HAAS. LEVEL OF EVIDENCE: II, prospective cohort study.

Meniscal rim instability has a high prevalence and a variable location.

INTRODUCTION: Most classification systems for lateral discoid meniscus do not evaluate instability of the meniscal peripheral rim. Considerable variability in the prevalence of peripheral rim instability has been published, and it appears that instability is underestimated. The purpose of this study was: first, to evaluate the prevalence of peripheral rim instability and its location in the symptomatic lateral discoid meniscus, and second, to investigate if patient age or type of discoid meniscus are possible risk factors for instability. METHODS: A cohort of 78 knees that underwent operative treatment due to symptomatic discoid lateral meniscus was analyzed retrospectively for the rate and location of peripheral rim instability. RESULTS: Out of the 78 knees, 57.7% (45) had a complete and 42.3% (33) had an incomplete lateral meniscus. The prevalence of peripheral rim instability in symptomatic lateral discoid menisci was 51.3%, and with 32.5%, the anterior attachment was most commonly affected, followed by the posterior (30%) and central (10%) attachment. 27.5% of the tested menisci were unstable anteriorly and posteriorly. There was no significant difference in the prevalence of rim instability between the type of discoid menisci (complete vs. incomplete), nor was there a significant correlation for age as a risk factor for instability. CONCLUSION: The discoid lateral meniscus has a high prevalence and variable location of peripheral rim instability. Meniscal rim stability must be tested and addressed cautiously in all parts and in all types of discoid lateral menisci during operative treatment.

No difference in patient-reported satisfaction after 12 months between customised individually made and off-the-shelf total knee arthroplasty.

PURPOSE: A subset of patients is usually not satisfied after a total knee arthroplasty (TKA). Customised individually made (CIM) TKA are deemed to overcome drawbacks of classical off-the-shelf (OTS) TKA, but evidence is still sparse. The aim of this study was to compare satisfaction of patients with CIM and OTS TKA. METHODS: This prospective cohort study compared clinical and patient-reported outcome measures (PROM) between patients with CIM and OTS TKA. The primary outcome was patient satisfaction after 12 months. Secondary outcomes were the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12) and the EQ-5D-3L after 4 and 12 months. RESULTS: Data were analysed from 74 CIM TKA and 169 OTS TKA between January 2017 and September 2020. Patients with CIM TKA were slightly younger, more often male, had a lower body mass index, a lower KSS and partially higher preoperative PROMs. Patient satisfaction after 12 months was high and comparable (CIM 87%, OTS 89%). All PROMs improved for both groups (p < 0.001) and did not differ after 12 months (p > 0.063). The majority of patients improved above the minimal important difference (range 65 to 89%) and reported a clear overall improvement (CIM 86%, OTS 87%). The postoperative KSS, notably regarding knee stability, was higher for CIM TKA (p < 0.001). CONCLUSION: No difference was found in patient satisfaction between CIM and OTS TKA after 12 months. In both groups, patient satisfaction was high and PROMs improved considerably. LEVEL OF EVIDENCE: II, prospective cohort study.

Relevant changes of leg alignment after customised individually made bicompartmental knee arthroplasty due to overstuffing.

PURPOSE: The purpose of this study is to analyse the change in knee alignment after customised individually made (CIM) bicompartmental knee arthroplasty (BKA) and the subsequent consequences for patellar tracking. METHODS: Medical records of 23 patients who received 26 CIM BKA (ConforMIS iDuo G2) at our clinic between November 2015 and July 2018 were reviewed. The objective part of the Knee Society Score (KSS), the hip-knee-ankle angle (HKA), the tibial mechanical angle (TMA) and femoral mechanical angle (FMA) were recorded preoperative and four months postoperative. Leg alignment was classified as neutral (HKA = 180° ± 3°), varus (HKA < 177°) or valgus (HKA > 183°). Furthermore, patellar tracking was determined on skyline view radiographs and adverse events were recorded. Implant survival rate was determined with the Kaplan-Meier method. Patient-reported outcome measures (PROMs) were pain, satisfaction, overall improvement and if the patient would undergo the surgery again. RESULTS: The mean KSS improved from 61 points preoperative [standard deviation (SD) 14] to 90 points postoperative (SD 7, p < 0.001). The mean change for HKA was 6.3° (SD 3.5), for TMA 1.5° (SD 1.2) and for FMA 3.8° (SD 2.3). Postoperative leg alignment was neutral in 13 CIM BKA (50%), varus in two (8%) and valgus in 11 (42%) and patella tracking was central in 19 CIM BKA (73%) and lateral in seven (27%), respectively. Adverse events occurred in five CIM BKA: three patients required a patella resurfacing and one patient with bilateral CIM BKA needed a revision to a total knee arthroplasty. Implant survival rate was 92.3% at a follow-up of 3.2 years (SD 0.8). PROMs for CIM BKA without revision surgery were available at a mean follow-up of 3.2 years (SD 0.8). Mean pain with level walking decreased to 0.8 points (SD 1.4, p < 0.001) and mean pain with stairs or inclines to 1.6 points (SD 1.3, p < 0.001). Patient satisfaction was very satisfied or satisfied (78%), neutral (17%) or unsatisfied (4%). Overall improvement was much better or considerably better for 91% of all patients; 87% would undergo the surgery again. CONCLUSION: A relevant change of the leg axis away from the treated femorotibial compartment due to overstuffing was observed. Although, neutral leg alignment was not restored in every case, clinical and patient-reported outcomes improved significantly. Further studies with long-term clinical and patient-reported outcomes are required to evaluate whether patients with bicompartmental knee osteoarthritis benefit from CIM BKA. LEVEL OF EVIDENCE: IV, case series.

The German version of the High-Activity Arthroplasty Score is valid and reliable for patients after total knee arthroplasty.

PURPOSE: The indications for a total knee arthroplasty (TKA) broadened to younger and more active patients. The High-Activity Arthroplasty Score (HAAS) is a self-administered instrument focussing on the wider range of functional abilities of more active patients. The HAAS was developed in English and is not available in German yet. This study aims to translate, cross-cultural adapt and assess the psychometric properties of the German HAAS in patients 12 months after primary TKA. METHODS: After forward and backward translation, we examined the final version regarding its psychometric properties in patients 12 months after primary TKA. The HAAS was sent out to 70 patients together with routine questionnaires comprising the Knee injury and Osteoarthritis Outcome Score (KOOS), the Forgotten Joint Score (FJS-12), the EuroQol (EQ-5D-3L) and 2 numerical pain rating scales. Acceptability, reliability, responsiveness, content and construct validity as well as floor and ceiling effects were evaluated. RESULTS: Fifty-two patients were recruited. The HAAS was well accepted with a mean time to completion of 2.4 min. Cronbach's alpha for internal consistency was 0.749, test-retest reliability was excellent with an Intraclass Correlation Coefficient (ICC) of 0.961. The smallest detectable change was 1.5. Good content validity was confirmed. A strong correlation was found between the HAAS and KOOS sport (r = 0.661) and a medium correlation for all other KOOS subscales (r = 0.324 to 0.453), the FJS-12 (r = 0.425), the EQ-5D-3L (r = 0.427) and pain (r = - 0.439 to - 0.308). The HAAS showed no floor and ceiling effects. CONCLUSIONS: The German version of the HAAS provides good validity and reliability. It can be easily self-administered and is recommended to capture high-intensity activities in patients after TKA. LEVEL OF EVIDENCE: Diagnostic study, Level I.

Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol.

INTRODUCTION: To evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty. METHODS AND ANALYSIS: This study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will conduct sensitivity analyses. ETHICS AND DISSEMINATION: The study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.

[Significance of Matrix-augmented Bone Marrow Stimulation for Treatment of Cartilage Defects of the Knee: A Consensus Statement of the DGOU Working Group on Tissue Regeneration]. / Stellenwert der matrixaugmentierten Knochenmarkstimulation in der Behandlung von Knorpelschäden des Kniegelenks: Konsensusempfehlungen der AG Klinische Geweberegeneration der DGOU.

Surgical principles for treatment of full-thickness cartilage defects of the knee include bone marrow stimulation techniques (i.e. arthroscopic microfracturing) and transplantation techniques (i.e. autologous chondrocyte implantation and osteochondral transplantation). On the basis of increasing scientific evidence, indications for these established therapeutical concepts have been specified and clear recommendations for practical use have been given. Within recent years, matrix-augmented bone marrow stimulation has been established as a new treatment concept for chondral lesions. To date, scientific evidence is limited and specific indications are still unclear. The present paper gives an overview of available products as well as preclinical and clinical scientific evidence. On the basis of the present evidence and an expert consensus from the "Working Group on Tissue Regeneration" of the German Orthopaedic and Trauma Society (DGOU), indications are specified and recommendations for the use of matrix-augmented bone marrow stimulation are given. In principle, it can be stated that the various products offered in this field differ considerably in terms of the number and quality of related studies (evidence level). Against the background of the current data situation, their application is currently seen in the border area between cell transplantation and bone marrow stimulation techniques, but also as an improvement on traditional bone marrow stimulation within the indication range of microfracturing. The recommendations of the Working Group have preliminary character and require re-evaluation after improvement of the study situation.

Good clinical results but moderate osseointegration and defect filling of a cell-free multi-layered nano-composite scaffold for treatment of osteochondral lesions of the knee.

PURPOSE: The aim of this retrospective study was to evaluate the clinical and radiological results of a nano-composite multi-layered three-dimensional biomaterial scaffold for treatment of osteochondral lesions (OCL) of the knee. It was a particular radiological interest to analyse the osseointegration, filling of the defects and the bone tracer uptake (BTU), and it was hypothesised that this scaffold, which was created to mimic the entire osteo-cartilaginous unit, is integrated within the bone 12 months postoperatively and comes along with improved patients symptoms and function. METHODS: Fourteen patients (male:female = 11:3, mean age ± SD 33.1 ± 10.7 years) treated for OCL (size 1.0-3.5 cm2) were clinically and radiologically evaluated at 1 year postoperatively. The data were prospectively collected including SPECT/CT, Tegner and Lysholm scores. BTU was anatomically localised and volumetrically quantified in SPECT/CT. Defect filling was analysed in CT. Spearman's rho and Wilcoxon test were used for correlation of BTU in SPECT/CT and clinical scores (p < 0.05). RESULTS: A significant improvement in Lysholm knee score (p < 0.001) and slight deterioration in Tegner score were found (p < 0.01). A complete filling of the defect was shown in 14%, a partial filling in 14% and only minor filling was seen in 72%. A significant correlation (p < 0.001) was found between location of osteochondral lesions and increased BTU. At the lesion sites pre- and postoperative BTU was markedly increased and did not show any decrease at 12-month follow-up. Median Tegner and mean Lysholm scores did not correlate with BTU at any time. CONCLUSIONS: Treatment of OCL in the knee joint with a nano-composite multi-layered three-dimensional biomaterial scaffold resulted in a significant clinical improvement at 1-year follow-up. However, osseointegration was still ongoing at 12-month follow-up. LEVEL OF EVIDENCE: Case series, Level IV.

Outcomes of elderly hip fracture patients in the Swiss healthcare system: A survey prior to the implementation of DRGs and prior to the implementation ofa Geriatric Fracture Centre.

UNLABELLED: PROBLEM AND QUESTIONS: The consequences for elderly patients with hip fractures are well known. In Switzerland, the introduction of diagnosis related groups (DRG) will bring additional challenges. New models of care, such as Geriatric Fracture Centres (GFC), may be the key to minimising negative outcomes. This study documents outcomes of hip fracture patients in the Swiss healthcare system, for use as baseline data prior to DRG- and GFC-implementation, and compares them to results reported in the literature, for example by Cooper (1997). METHODS: This was a prospective cohort quality assurance survey with a one-year follow-up. Outcomes were mortality, living situation, required support and mobility. All patients 65 years of age or older with a proximal femoral fracture were included. Data were analysed by descriptive and interferential statistics. RESULTS: From 272 patients, 70% were community dwelling pre-fracture. Overall, one-year mortality was 22%. Pre-fracture community dwelling patients had better outcomes than nursing home patients with a one-year mortality rate of 12%. A total of 83% of pre-fracture community dwelling patients still lived in the community after one year but more needed help with activities of daily living (ADL) or mobility. Patients with dementia, ADL- and mobility dependency pre-fracture were significantly more at risk for being newly admitted to a nursing home. CONCLUSIONS: Our results reflect the clinical reality of the hip fracture population in Switzerland. Results one year after fracture were comparable to study findings in different health care systems. Our findings provide important baseline data prior to the implementation of DRG and GFC.