Risk and Epidemiology of Periprosthetic Knee Fractures After Primary Total Knee Arthroplasty: A Nationwide Cohort Study.

BACKGROUND: Periprosthetic knee fractures (PPKFs) following total knee arthroplasty (TKA) are uncommon, but potentially serious injuries. We analyze the risk and risk factors for a PPKF in standard primary TKA patients who have osteoarthritis and a minimally (cruciate-retaining TKAs without a femoral box cut) or posterior-stabilized TKA. In addition, we report the risk for patients who have other underlying knee disorders and/or a higher level of TKA constraint. METHODS: All primary TKAs were identified from the Danish National Patient Register and the Danish Knee Arthroplasty Register using data between 1997 and 2022. Subsequent fractures were identified through the International Classification of Diseases diagnosis code, Nordic Medico-Statistical Committee procedure code, or indication for revision TKA. RESULTS: We included 120,642 standard primary TKA patients who had 1,659 PPKFs. The cumulated proportions were 0.4% (95% confidence interval (CI) 0.3 to 0.4) at 2 years 0.8% (0.7 to 0.8) at 5 years. At 10 years, the cumulated proportion was 1.7% (1.6 to 1.8), with 1.3% in the femur, 0.2% in the patella, and 0.2% in the tibia. Significant risk factors were (hazard ratio [HR] [95% CI]); ipsilateral hip arthroplasty (2.3 [2.0 to 2.6]); women (2.1 [1.8 to 2.4]), osteoporosis (1.4 [1.2 to 1.7]); age 80+ (1.4 [1.3 to 1.6]), uncemented TKA (1.3 (1.1 to 1.5) and Charlson Comorbidity Index score 3+ (1.4 [1.1 to 1.8]). An additional 22,624 primary TKA patients who had other underlying knee disorders and/or a higher level of implant constraint were included with 633 PPKFs. The 10-year cumulated proportions were 8.3% (95% CI 6.9 to 9.8) when the underlying disorder was a previous fracture, 2.8% (2.2 to 3.5) for rheumatic disorders, and 5.2% (2.6 to 10.6) for osteonecrosis. In patients who had condylar constrained knees, it was 6.9% (5.1 to 9.4), and 12.4% (8.0 to 16.04) for hinges. CONCLUSIONS: In standard primary TKA patients, the 10-year cumulated proportion of PPKFs was 1.7%, and ipsilateral hip arthroplasty, women, osteoporosis, advanced age, uncemented TKA and higher Charlson Comorbidity Index increased the risk. Higher risks were observed in non-osteoarthritis patients and/or patients who had a higher level of TKA constraint.

Incidence and survival of multiply revised knee arthroplasties in Denmark 1998-2021: a nationwide register-based study.

PURPOSE: The primary aim of our study was to identify the absolute incidence and implant survival of multiply revised knee arthroplasties based on nationwide register data. The secondary aim was to determine the change in the absolute incidence and implant survival of multiply revised knee arthroplasties Methods: We performed a retrospective observational study of primary knee arthroplasties using several nationwide Danish registers. All primary knee arthroplasties performed in Denmark from 1998 to 2021 were identified. From these primary arthroplasties, revision procedures were identified. Kaplan-Meier plots were used in survival analysis to estimate the likelihood of implant survival. RESULTS: 161,384 primary knee arthroplasties and their revisions performed between 1998 and 2021 were identified; of 13,786 (8.5%) revisions there were 10,638 1st revisions, 2,148 2nd revisions, 624 3rd revisions, 223 4th revisions, and 153 procedures that had been revised more than 4 times. The 10-year revision-free survival of primary arthroplasties was 92.3% (95% confidence interval [CI] 92.2-92.5). First-time revisions had a 10-year revision-free survival of 75.9% (CI 74.9-76.9). The 10-year survival of second- and third-time revisions was 65.1% (CI 62.6-67.6) and 57.8% (CI 53.4-62.5), respectively. The 10-year implant survival probabilities of primary knee arthroplasties were 91.4% in 1998-2009 and 93.3% in 2010-2021 (difference 2.2%). The 10-year implant survival probabilities of 1st revisions were 77% in 1998-2009 and 75% in 2010-2021 (difference -2.4%). CONCLUSION: We found that 0.3% of all primary knee arthroplasties resulted in 3 or more revisions. The implant survival decreased for each consecutive revision, with almost half of the 3rd revisions being re-revised within 10 years. The 10-survival of the primary implant was higher in 2010-2021, and the 10-year survival of the 1st revision was higher in 1998-2009.

Microvascular free flap coverage of complex soft tissue defects after revision total knee arthroplasty: a cross-sectional observation study.

BACKGROUND AND PURPOSE: Soft tissue defects after total knee arthroplasties (TKA) represent a major orthopedic challenge with amputation as a feared outcome. Microvascular free flap coverage (FFC) can increase limb salvage rates, but complications related to the procedure are yet to be explored further. We aimed to review a single-center experience with FFC for soft tissue defects related to revision total knee arthroplasty. METHODS: Through a retrospective chart review from 2006 to 2021, we identified all patients who had FFC of a knee with an existing TKA. Typically, patients underwent 2-stage revision arthroplasty. To identify areas of intervention, we divided the entire regimen into 2 phases divided by the free flap surgery (pre- and post-free flap). RESULTS: We identified 18 patients with a median age at free flap surgery of 69 years (range 39-85), who were followed for a median of 5.1 years (range 2 months to 10.6 years). The median duration from primary TKA to their final operation was 17.5 months (range 19 days to 7 years). Patients underwent a mean of 7.6 surgical procedures on their knee with 3.6 orthopedic revisions prior to the FFC and 0.6 after. Soft tissue coverage was achieved in all patients and no patients underwent amputation. One-third of patients experienced early complications at recipient site after free flap surgery. There were no donor site complications. CONCLUSION: Microvascular FFC of complex soft tissue defects after revision total knee arthroplasty proved achievable in all patients with successful limb salvage in all patients.

Preoperative proximal tibial bone density, bone microarchitecture, and bone turnover are not associated with postoperative tibial component migration in cemented and cementless medial unicompartmental knee replacements: secondary analyses from a randomized controlled trial.

BACKGROUND AND PURPOSE: Cementless arthroplasty fixation relies on early bone ingrowth and may be poor in patients with low proximal tibial bone density or abnormal bone turnover. We aimed first to describe the baseline bone properties in patients undergoing medial unicompartmental knee replacement (UKR), and second to investigate its association with cemented and cementless tibial component migration until 2 years. METHODS: A subset investigation of 2 patient groups from a 3-armed randomized controlled trial was conducted. There were 26 cemented and 25 cementless medial UKRs with twin-pegged femoral components. Volumetric bone mineral density (vBMD) and microstructure of the excised medial tibial plateau were ascertained with µCT. Bone turnover was estimated using dynamic histomorphometry (eroded surface/bone surface = ES/BS, osteoid surface/bone surface = OS/BS, mineralizing surface/bone surface = MS/BS). Tibial component migration in 4 feature points was followed for 2 years with radiostereometry. RESULTS: At the 2-year follow-up, the cementless tibial components migrated 0.38 mm (95% confidence interval [CI] 0.14-0.62) total translation more than the cemented components at the posterior feature point. The greatest migration in the cementless group was subsidence at the posterior feature point of 0.66 mm (CI 0.48-0.84) until 6 weeks, and from 3 months the components were stable. Cemented tibial components subsided very little. Between 1- and 2-year follow-ups, no cementless but 4 cemented tibial components revealed continuous migration. OS/BS was half of the ES/BS. No µCT or histomorphometric parameters showed any clinically relevant correlation with tibial component migration at the posterior feature point for either cemented or cementless UKR at 6 weeks' or 2 years' follow-up after adjustment for age, BMI, and sex. CONCLUSION: Preoperative vBMD, bone turnover, and microstructure were not associated with postoperative tibial component migration of cemented and cementless medial UKR.

Patients in high- and low-revision hospitals have similar outcomes after primary knee arthroplasty: 1-year postoperative results from the Danish prospective multicenter cohort study, SPARK.

PURPOSE: It is well-known that revision rates after primary knee arthroplasty vary widely. However, it is uncertain whether hospital revision rates are reliable indicators of general surgical quality as defined by patients. The SPARK study compared primary knee arthroplasty surgery at three high-volume hospitals whose revision rates differed for unknown reasons. METHODS: This prospective observational study included primary knee arthroplasty patients (total, medial/lateral unicompartmental and patellofemoral) in two low-revision hospitals (Aarhus University Hospital and Aalborg University Hospital Farsø) and one high-revision hospital (Copenhagen University Hospital Herlev-Gentofte). Patients were followed from preoperatively (2016-17) to 1-year postoperatively with patient-reported outcome measures including Oxford Knee Score (OKS), EQ-5D-5L and Copenhagen Knee ROM (range of motion) Scale. The surgical outcomes were compared across hospitals for patients with comparable grades of radiographic knee osteoarthritis and preoperative OKS. Statistical comparisons (parametric and non-parametric) included all three hospitals. RESULTS: 97% of the 1452 patients who provided baseline data (89% of those included and 56% of those operated) responded postoperatively (90% at 1 year). Hospitals' utilization of unicompartmental knee arthroplasties differed (Aarhus 49%, Aalborg 14%, and Copenhagen 22%, p < 0.001). 28 patients had revision surgery during the first year (hospital independent, p = 0.1) and were subsequently excluded. 1-year OKS (39 ± 7) was independent of hospital (p = 0.1), even when adjusted for age, sex, Body Mass Index, baseline OKS and osteoarthritis grading. 15% of patients improved less than Minimal Important Change (8 OKS) (Aarhus 19%, Aalborg 13% and Copenhagen 14%, p = 0.051 unadjusted). Patients with comparable preoperative OKS or osteoarthritis grading had similar 1-year results across hospitals (OKS and willingness to repeat surgery, p ≥ 0.087) except for the 64 patients with Kellgren-Lawrence grade-4 (Aarhus 4-6 OKS points lower). 86% of patients were satisfied, and 92% were "willing to repeat surgery", independent of hospital (p ≥ 0.1). Hospital revision rates differences diminished during the study period. CONCLUSIONS: Patients in hospitals with a history of differing revision rates had comparable patient-reported outcomes 1 year after primary knee arthroplasty, supporting that surgical quality should not be evaluated by revision rates alone. Future studies should explore if revision rate variations may depend as much on revision thresholds and indications as on outcomes of primary surgery. LEVEL OF EVIDENCE: Level II (Prospective cohort study).

Hospital variation in revision rates after primary knee arthroplasty was not explained by patient selection: baseline data from 1452 patients in the Danish prospective multicenter cohort study, SPARK.

PURPOSE: Revision rates following primary knee arthroplasty vary by country, region and hospital. The SPARK study was initiated to compare primary surgery across three Danish regions with consistently different revision rates. The present study investigated whether the variations were associated with differences in the primary patient selection. METHODS: A prospective observational cohort study included patients scheduled Sep 2016 Dec 2017 for primary knee arthroplasty (total, medial/lateral unicompartmental or patellofemoral) at three high-volume hospitals, representing regions with 2-year cumulative revision rates of 1, 2 and 5%, respectively. Hospitals were compared with respects to patient demographics, preoperative patient-reported outcome measures, motivations for surgery, implant selection, radiological osteoarthritis and the regional incidence of primary surgery. Statistical tests (parametric and non-parametric) comprised all three hospitals. RESULTS: Baseline data was provided by 1452 patients (89% of included patients, 56% of available patients). Patients in Copenhagen (Herlev-Gentofte Hospital, high-revision) were older (68.6 ± 9 years) than those in low-revision hospitals (Aarhus 66.6 ± 10 y. and Aalborg (Farsø) 67.3 ± 9 y., p = 0.002). In Aalborg, patients who had higher Body Mass Index (mean 30.2 kg/m2 versus 28.2 (Aarhus) and 28.7 kg/m2 (Copenhagen), p < 0.001), were more likely to be male (56% versus 45 and 43%, respectively, p = 0.002), and exhibited fewer anxiety and depression symptoms (EQ-5D-5L) (24% versus 34 and 38%, p = 0.01). The preoperative Oxford Knee Score (23.3 ± 7), UCLA Activity Scale (4.7 ± 2), range of motion (Copenhagen Knee ROM Scale) and patient motivations were comparable across hospitals but varied with implant type. Radiological classification ≥ 2 was observed in 94% (Kellgren-Lawrence) and 67% (Ahlbäck) and was more frequent in Aarhus (low-revision) (p ≤ 0.02), where unicompartmental implants were utilized most (49% versus 14 (Aalborg) and 23% (Copenhagen), p < 0.001). In the Capital Region (Copenhagen), the incidence of surgery was 15-28% higher (p < 0.001). CONCLUSION: Patient-reported outcome measures prior to primary knee arthroplasty were comparable across hospitals with differing revision rates. While radiographic classifications and surgical incidence indicated higher thresholds for primary surgery in one low-revision hospital, most variations in patient and implant selection were contrary to well-known revision risk factors, suggesting that patient selection differences alone were unlikely to be responsible for the observed variation in revision rates across Danish hospitals. LEVEL OF EVIDENCE: II, Prospective cohort study.

Comparison of cementless twin-peg, cemented twin-peg and cemented single-peg femoral component migration after medial unicompartmental knee replacement: a 5-year randomized RSA study.

BACKGROUND: The component design and fixation method of joint arthroplasty may affect component migration and survival. The aim of this study was to compare fixation of cementless twin-peg (CLTP), cemented twin-peg (CTP) and cemented single-peg (CSP) femoral components of medial unicompartmental knee replacement (UKR). METHODS: Eighty patients (mean age = 63 years, 48 males) with medial knee osteoarthritis were randomized in three ways to CLTP (n = 25), CTP (n = 26) or CSP (n = 29) femoral UKR components. The patients were followed 5 years postoperatively with RSA, bone mineral density (BMD), PROMs and radiological evaluation of radiolucent lines (RLL), femoral component flexion angle and complications. RESULTS: At the 5-year follow-up, femoral component total translation was comparable between the three groups (p = 0.60). Femoral component internal rotation was 0.50° (95% CI 0.3; 0.69) for the CLTP group, 0.58° (95% CI 0.38; 0.77) for the CTP group and 0.25° (95% CI 0.07; 0.43) for the CSP group (p = 0.01). BMD decreased peri-prosthetically (range - 11.5%; - 14.0%) until 6-month follow-up and increased toward the 5-year follow-up (range - 3.6%; - 5.8%). BMD change did not correlate with component migration. Lower flexion angle was correlated with higher 5-year subsidence, total translation, varus rotation and maximum total point motion (p = 0.01). Two patients (1 CLTP, 1 CTP) had RLL in the posterior zone. There were two revisions. CONCLUSION: At 5-year follow-up, fixation of UKA femoral components with twin-peg was not superior to the single-peg design. Cementless and cemented twin-peg femoral components had similar fixation. A lower flexion angle was correlated with higher component migration.

Patellofemoral Arthroplasty Results in Better Time-weighted Patient-reported Outcomes After 6 Years than TKA: A Randomized Controlled Trial.

BACKGROUND: In a previous study, we reported the 2-year outcomes of a parallel-group, equivalence, randomized controlled trial (RCT; blinded for the first year) comparing patellofemoral arthroplasty (PFA) and TKA for isolated patellofemoral osteoarthritis (PF-OA). We found advantages of PFA over TKA for ROM and various aspects of knee-related quality of life (QOL) as assessed by patient-reported outcomes (PROs). Register data show increases in PFA revision rates from 2 to 6 years after surgery at a time when annual TKA revision rates are decreasing, which suggests rapidly deteriorating knee function in patients who have undergone PFA. We intended to examine whether the early advantages of PFA over TKA have deteriorated in our RCT and whether revision rates differ between the implant types in our study after 6 years of follow-up. QUESTIONS/PURPOSES: (1) Does PRO improvement during the first 6 postoperative years differ between patients who have undergone PFA and TKA? (2) Does the PRO improvement at 3, 4, 5, and 6 years differ between patients who have undergone PFA and TKA? (3) Do patients who have undergone PFA have a better ROM after 5 years than patients who have had TKA? (4) Does PFA result in more revisions or reoperations than TKA during the first 6 postoperative years? METHODS: We considered patients who had debilitating symptoms and PF-OA as eligible for this randomized trial. Screening initially identified 204 patients as potentially eligible; 7% (15) were found not to have sufficient symptoms, 21% (43) did not have isolated PF-OA, 21% (43) declined participation, and 1% (3) were not included after the target number of 100 patients had been reached. The included 100 patients were randomized 1:1 to PFA or TKA between 2007 and 2014. Of these, 9% (9 of 100) were lost before the 6-year follow-up; there were 12% (6 of 50) and 0% (0 of 50) deaths (p = 0.02) in the PFA and TKA groups, respectively, but no deaths could be attributed to the knee condition. There were no differences in baseline parameters for patients who had PFA and TKA, such as the proportion of women in each group (78% [39 of 50] versus 76% [38 of 50]; p > 0.99), mean age (64 ± 9 years versus 65 ± 9 years; p = 0.81) or BMI (28.0 ± 4.7 kg/m 2 versus 27.8 ± 4.1 kg/m 2 ; p = 0.83). Patients were seen for five clinical follow-up visits (the latest at 5 years) and completed 10 sets of questionnaires during the first 6 postoperative years. The primary outcome was SF-36 bodily pain. Other outcomes were reoperations, revisions, ROM, and PROs (SF-36 [eight dimensions, range 0 to 100 best, minimum clinically important difference {MCID} 6 to 7], Oxford Knee Score [OKS; one dimension, range 0 to 48 best, MCID 5], and Knee Injury and Osteoarthritis Outcome Score [KOOS; five dimensions, range 0 to 100 best, MCID 8 to 10]). Average PRO improvements over the 6 years were determined by calculating the area under the curve and dividing by the observation time, thereby obtaining a time-weighted average over the entire postoperative period. PRO improvements at individual postoperative times were compared for the patients who had PFA and TKA using paired t-tests. Range of movement changes from baseline were compared using paired t-tests. Reoperation and revision rates were compared for the two randomization groups using competing risk analysis. RESULTS: Patients who underwent PFA had a larger improvement in the SF-36 bodily pain score during the first 6 years than those who underwent TKA (35 ± 19 vs. 23 ± 17; mean difference 12 [95% CI 4 to 20]; p = 0.004), and the same was true for SF-36 physical functioning (mean difference 11 [95% CI 3 to 18]; p = 0.008), KOOS Symptoms (mean difference 12 [95% CI 5 to 20]; p = 0.002), KOOS Sport/recreation (mean difference 8 [95% CI 0 to 17]; p = 0.048), and OKS (mean difference 5 [95% CI 2 to 8]; p = 0.002). No PRO dimension had an improvement in favor of TKA. At the 6-year time point, only the SF-36 vitality score differed between the groups being in favor of PFA (17 ± 19 versus 8 ± 21; mean difference 9 [95% CI 0 to 18]; p = 0.04), whereas other PRO measures did not differ between the groups. At 5 years, ROM had decreased less from baseline for patients who underwent PFA than those who had TKA (-4° ± 14° versus -11° ± 13°; mean difference 7° [95% CI 1° to 13°]; p = 0.02), but the clinical importance of this is unknown. Revision rates did not differ between patients who had PFA and TKA at 6 years with competing risk estimates of 0.10 (95% CI 0.04 to 0.20) and 0.04 (95% CI 0.01 to 0.12; p = 0.24), respectively, and also reoperation rates were no different at 0.10 (95% CI 0.04 to 0.20) and 0.12 (95% CI 0.05 to 0.23; p = 0.71), respectively. CONCLUSION: Our RCT results show that the 2-year outcomes did not deteriorate during the subsequent 4 years. Patients who underwent PFA had a better QOL throughout the postoperative years based on several of the knee-specific outcome instruments. When evaluated by the 6-year observations alone and without considering earlier observations, we found no consistent difference for any outcome instruments, although SF-36 vitality was better for patients who underwent PFA. These combined findings show that the early advantages of PFA determined the results by 6 years. Our findings cannot explain the rapid deterioration of results implied by the high revision rates observed in implant registers, and it is necessary to question indications for the primary procedure and subsequent revision when PFA is in general use. Our data do not suggest that there is an inherent problem with the PFA implant type as otherwise suggested by registries. The long-term balance of advantages will be determined by the long-term QOL, but based on the first 6 postoperative years and ROM, PFA is still the preferable option for severe isolated PF-OA. A possible high revision rate in the PFA group beyond 6 years may outweigh the early advantage of PFA, but only detailed analyses of long-term studies can confirm this. LEVEL OF EVIDENCE: Level I, therapeutic study.

Four of five frequently used orthopedic PROMs possess inadequate content validity: a COSMIN evaluation of the mHHS, HAGOS, IKDC-SKF, KOOS and KNEES-ACL.

PURPOSE: Content validity is the most important property of PROMs. The COSMIN initiative has published guidelines for evaluating the content validity of PROMs, but they have only sparsely been applied to relevant PROMs for musculoskeletal conditions. The aim of this study was to use the COSMIN Risk of Bias checklist to evaluate the content validity of five PROMs, that are highly relevant in musculoskeletal research and used by the arthroscopic surgery community: the modified Harris' Hip Score (mHHS), the Copenhagen Hip and Groin Outcome Score (HAGOS), the International Knee Documentation Committee Subjective Knee evaluation Form (IKDC-SKF), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Knee Numeric-Entity Evaluation Score ACL (KNEES-ACL). METHODS: The development articles for the five PROMs were identified through searches in PubMed and SCOPUS. A literature search was performed to identify additional studies assessing content validity of the PROMs. Additional information, necessary for the assessments, was obtained from the PROM developers after direct request. To evaluate the quality of the development studies and rate the content validity, the COSMIN Risk of Bias checklist was applied to all studies. RESULTS: All five development studies were identified. Three subsequent content validity studies were identified, all evaluating KOOS and one also IKDC. One content validity study was of inadequate quality and excluded from further analysis. The development of mHHS, IKDC-SKF, and KOOS was rated inadequate and possess insufficient content validity for their target populations. Due to the irrelevance of multiple items, KOOS was in particular inappropriate to evaluate patients with an ACL injury. The development of HAGOS was also rated inadequate, although the insufficiency aspects can be regarded as minor. KNEES-ACL possessed sufficient content validity. CONCLUSION: Out of five PROMs, only KNEES-ACL possessed sufficient content validity. Particularly, KOOS should not be used as an outcome for patients with an ACL injury. There is an urgent need for condition-specific PROMs for musculoskeletal conditions, developed with adequate methods. LEVEL OF EVIDENCE: III.

The Rosenberg view and coronal stress radiographs give similar measurements of articular cartilage height in knees with osteoarthritis.

PURPOSE: Choosing the optimal radiographic methods to diagnose the cartilage height and degree of knee osteoarthritis is crucial to determine suitability for unicompartmental knee replacement. This study aims to evaluate and compare articular cartilage thickness measured using the Rosenberg view and coronal stress radiography. Intra- and interrater agreement and test-retest reliability of each method were determined. The hypothesis of the study was that the Rosenberg view and coronal stress radiographs provide similar assessments of articular cartilage height in the medial and lateral knee compartments of osteoarthritic knees. METHODS: A prospective diagnostic study, including 73 patients was performed. Inclusion criteria were enrollment for either a medial unicompartmental or a total knee replacement. Radiographs were taken as the Rosenberg view, and coronal stress radiography using the Telos stress device. Repeated measurements were performed. Experienced knee surgeons performed measurements of cartilage height at a standardized location of joint space width (JSW), and a rater-perceived location of minimal joint space width (mJSW), thus allowing for reliability and agreement analysesusing weighted kappa. Coronal stress measurements were ultimately compared to the Rosenberg view using Spearman's rank correlation. RESULTS: A total of 12,264 measurements were performed. The radiographic methods proved substantial reliability. Intra- and interrater agreement showed substantial to almost perfect agreement. A very strong correlation was observed in the medial knee compartment (r = 0.91; CI = 0.84-0.95; p < 0.001), with a mean difference of 0.1 mm and limits of agreement of - 1.5 to 1.7 mm, when comparing JSW between the Rosenberg view and varus stress. Only a strong correlation was observed medially when using mJSW, and when using this measurementmore incidences of bone-on-bone were observed than when measuring with JSW. A Strong correlation was observed in the lateral knee compartment (r = 0.83; CI = 0.71-0.89; p < 0.001), with a mean difference of 0.62 mm and limits of agreement of - 1.5 to 2.7 mm, when comparing JSW between the Rosenberg view and valgus stress. CONCLUSION: The Rosenberg view is similar to 20° coronal valgus-varus stress radiography for determining articular cartilage thickness. Both techniques can be used in a clinical setting. Therefore, extra radiographs, equipment and expertise could be saved, when solely utilizing the Rosenberg view which is simple to perform. LEVEL OF EVIDENCE: III.

One-stage versus two-stage revision of the infected knee arthroplasty - a randomized multicenter clinical trial study protocol.

BACKGROUND: A two-stage prosthesis exchange procedure has been the gold standard in surgical treatment of the chronically infected knee arthroplasty so far. This includes 2 surgeries/hospitalizations and an interim period of 2-3 months between surgeries with impaired health, functional status and quality of life of the patients. A one-stage exchange procedure holds many obvious advantages compared to the two-stage approach, but outcomes of a one-stage versus two-stage procedures have never been investigated in a randomized clinical trial. The purpose of this study is primarily to investigate time-adjusted differences in functional status of patients after one-stage versus two-stage revision. Secondary, to report time-adjusted differences in quality of life, complications (including re-revisions due to infection) and mortality. METHODS: This study is a pragmatic, multi-center, randomized, non-inferiority trial comparing one-stage versus two-stage revision of the infected knee arthroplasty. Seven Danish hospitals are currently participating in the study, but additional hospitals can enter the study if adhering to protocol. Ninety-six patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 10 years. The patients who are not able to participate in the randomized trial are followed in a parallel cohort study. PROM'S: Oxford Knee Score and EQ5D + EQ5D VAS questionnaires are completed preoperatively and sent out to the study participants at 6 weeks, 3, 6, 9, 12, 18 and 24 months as well as 5 and 10 years postoperatively. In addition a tailor made cost questionnaire on the non-treating hospital resource use, community health and social service use, travel costs, time off work and informal care are sent out. DISCUSSION: If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted. Other outcomes will open informed discussions about treatment strategies for periprosthetic knee infections. TRIAL REGISTRATION: The randomized trial is registered on ClinicalTrials.gov with ID NCT03435679 , initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020.

Measurement properties of UCLA Activity Scale for hip and knee arthroplasty patients and translation and cultural adaptation into Danish.

Background and purpose - The UCLA Activity Scale (UCLA) is a questionnaire assessing physical activity level from 1 (low) to 10 (high) in patients undergoing hip or knee arthroplasty (HA/KA). After translation and cultural adaptation, we evaluated the measurement properties of the Danish UCLA.Patients and methods - After dual panel translation, cognitive interviews were performed among 55 HA/KA patients. An orthopedic surgeon and a physiotherapist estimated UCLA scores for 80 KA patients based on short interviews. Measurement properties were evaluated in 130 HA and 134 KA patients preoperatively and 1-year postoperatively.Results - To suit Danish patients of today, several adaptations were required. Prior to interviews, 4 patients were excluded, and 11 misinterpreted the answer options. Examiners rated the remaining 65 patients (mean age 67 years) 0.2-1.6 UCLA levels lower than patients themselves. The 130 HA and 134 KA patients (mean age 71/68 years) changed from 4.3 (SD 1.9)/4.5 (1.8) preoperatively to 6.6 (1.8)/6.2 (1.0) at 1-year follow-up. 103 (79%) HA and 89 (66%) KA patients reported increased activity. Effect sizes were large (1.2/0.96). Knee patients reaching minimal important change (MIC, ≥ 8 Oxford Knee Score points) had higher 1-year UCLA scores than patients not reaching MIC.Interpretation - Original scale development was undocumented. Content validity was questionable, and there was discrepancy between patient and examiner estimates. UCLA appears valuable for measuring change in self-reported physical activity on a group level. 4 out of 5 HA patients and 2 out of 3 KA patients were more physically active 1 year after joint replacement surgery.

Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.

BACKGROUND: The risk of periprosthetic joint infection (PJI), a serious complication after arthroplasty, has not changed for years. Interventions such as eradication of Staphylococcus aureus and antibiotic bone cement are used to diminish infection risk but despite these efforts, the percentage of infection in TKA remains constant. Antimicrobial drapes have a dual action, acting both as a physical and antimicrobial barrier to counter bacterial contamination of the surgical wound. To study the effect of antimicrobial drapes, we used intraoperative contamination as a proxy for infection in our investigation. QUESTIONS/PURPOSES: (1) Do antimicrobial surgical drapes reduce the risk of intraoperative microbial contamination in patients undergoing primary knee arthroplasty? (2) Are other factors such as sex, season, age, type of arthroplasty and duration of surgery associated with an increased risk of contamination in patients undergoing primary knee arthroplasty? (3) Does loosening of the antimicrobial drape increase contamination risk? METHODS: An investigator-initiated, two-arm, non-blinded, multicenter, randomized, controlled trial was performed at five different hospitals in the capital and central regions of Denmark. Twenty-four surgeons participated in the study. Participants were patients older than 18 years undergoing primary knee arthroplasty. We excluded patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery, and if they were unable to understand the implications of study participation. Patients were randomly assigned to operation with an antimicrobial drape (intervention group) or operation without (control group). We screened 1769 patients, of which 100 were ineligible and 10 declined to participate. In all, 94% (1659 of 1769) of patients consented and were randomized to the intervention group (51%, 838 of 1659) and control group (49%, 821 of 1659), respectively. In all, 36% (603 of 1659) of patients in the intervention group and 35% (584 of 1659) patients in the control group were available for final analysis. No crossover was performed, and analysis was done per-protocol. Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons. Intraoperatively, we swabbed for bacteria at the surgical site and in a rinse from the surgeons' gloves. All samples were sent for cultivation, and colony forming units (CFUs) counts ≥ 1 were deemed contaminated. The primary outcome measure was the difference in the proportion of contaminated patients between the two randomized groups. Secondary outcome measures were the affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk. To investigate whether other factors were affiliated with contamination risk, we did a logistic regression to control for confounding variables, including sex, age, season, type of implant and duration of surgery. RESULTS: Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients. After controlling for confounding variables such as sex, age, type of implant, and duration of surgery, we found that not using an antimicrobial drape increased contamination risk by a factor of 1.6 (95% CI 1.08 to 2.35; p = 0.02). Female sex and undergoing surgery in the central region were associated with lower odds of contamination (OR 0.55 [95% CI 0.39 to 0.8]; p = 0.002 and OR 0.45 [95% CI 0.25 to 0.8]; p = 0.006, respectively). Patients with more than a 10-mm separation of the drape from the skin had higher odds of contamination (OR 3.54 [95% CI 1.64 to 11.05]; p = 0.0013). CONCLUSIONS: The use of an antimicrobial drape resulted in lower contamination risk than operating without an antimicrobial drape. Our findings suggest that antimicrobial drapes are useful in infection prevention, but further studies are needed to investigate the effect of antimicrobial drapes on infection. LEVEL OF EVIDENCE: Level I, therapeutic study.

Does intraoperative contamination during primary knee arthroplasty affect patient-reported outcomes for patients who are uninfected 1 year after surgery? A prospective cohort study of 714 patients.

Background and purpose - It is well recognized that some knee arthroplasty (KA) patients present with prolonged postoperative inflammation and some develop persistent pain. It can reasonably be speculated that some of these problems develop because of low-grade infections with low virulence bacteria caused by intraoperative contamination. This prospective study was performed to investigate whether intraoperative contamination results in lower patient-reported outcomes (PRO) for patients who were clinically uninfected in the first year after surgery. Patients and methods - We combined data from 2 major prospective studies on patients undergoing primary KA at 2 Danish hospitals between September 2016 and January 2018. Pre- and postoperative (1.5, 3, 6, and 12 months) PROs and intraoperative microbiological cultures were obtained on a total of 714 patients who were included in the study. Based on the microbiological cultures, the patients were divided into 2 groups, contaminated and non-contaminated, and differences in PROs between the 2 groups were analyzed. Results - 84 of 714 (12%) patients were intraoperatively contaminated; none of the 714 patients developed clinical infection. The preoperative Oxford Knee Score was 24 and 23 for contaminated and non-contaminated patients, respectively, improving to 40 and 39 at 1 year (p = 0.8). 1-year AUC for Oxford Knee Score and absolute improvement at each postoperative time point for Forgotten Joint Score and EQ-5D-5L also were similar between contaminated and non-contaminated patients. Interpretation - Patient-reported outcomes from 714 patients do not indicate that intraoperative contamination affects the knee-specific or general health-related quality of life in primary KA patients who are clinically uninfected 1 year after surgery.

Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol.

BACKGROUND: In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic. METHODS: A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years. DISCUSSION: Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded. PROMS: OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03396640 . Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.

Failure modes of patellofemoral arthroplasty-registries vs. clinical studies: a systematic review.

Background and purpose - Patellofemoral arthroplasty (PFA) has been debated since early studies showed poor implant survival. Recent studies show better results. This review reports failure modes for PFA and investigates differences in data reported from registries and clinical studies. Additionally, we report differences in failure modes among implant designs. Methods - A systematic search was performed in September 2018. All studies and registers describing failure modes of PFA were included and implant design was noted for each revision. Results - This review includes 1,299 revisions of a primary PFA reported in 47 clinical studies and 3 registers. The failure modes were: 42% OA progression, 16% pain, 13% aseptic loosening, 12% surgical error, 4% wear, 2% infection, 2% broken patellar component, 1% stiffness, 1% fracture, and 7% other. The data from registries and cohort studies differed statistically significantly in 7 out of 12 failure modes. Significant differences were found in several failure modes among implant designs. Interpretation - OA progression is the most common failure mode of PFA. There are significant differences in data on failure modes between registers and protocolled studies, notably for surgical error. The implant design significantly influences several of the failure modes. In conclusion, indication, surgical technique, and implant design are important for a successful PFA, and register-based failure modes should be interpreted with caution.

Relationship between outcome scores and knee laxity following total knee arthroplasty: a systematic review.

Background and purpose - Instability following primary total knee arthroplasty (TKA) is, according to all national registries, one of the major failure mechanisms leading to revision surgery. However, the range of soft-tissue laxity that favors both pain relief and optimal knee function following TKA remains unclear. We reviewed current evidence on the relationship between instrumented knee laxity measured postoperatively and outcome scores following primary TKA. Patients and methods - We conducted a systematic search of PubMed, Embase, and Cochrane databases to identify relevant studies, which were cross-referenced using Web of Science. Results - 14 eligible studies were identified; all were methodologically similar. Both sagittal and coronal laxity measurement were reported; 6 studies reported on measurement in both extension and flexion. In knee extension from 0° to 30° none of 11 studies could establish statistically significant association between laxity and outcome scores. In flexion from 60° to 90° 6 of 9 studies found statistically significant association. Favorable results were reported for posterior cruciate retaining (CR) knees with sagittal laxity between 5 and 10 mm at 75-80° and for knees with medial coronal laxity below 4° in 80-90° of flexion. Interpretation - In order to improve outcome following TKA careful measuring and adjusting of ligament laxity intraoperatively seems important. Future studies using newer outcome scores supplemented by performance-based scores may complement current evidence.

Similar polyethylene wear between cemented and cementless Oxford medial UKA: a 5-year follow-up randomized controlled trial on 79 patients using radiostereometry.

Background and purpose - Hydroxyapatite (HA)-coated implants have been associated with high polyethylene wear in hip arthroplasties. HA coating as a promoter of wear in knee arthroplasties has not been investigated. We compared the wear-rate of the polyethylene bearing for cemented and cementless HA-coated Oxford medial unicondylar knee arthroplasties (UKA). Secondarily, we investigated whether wear-rates were influenced by overhang or impingement of the bearing. Patients and methods - 80 patients (mean age 64 years), treatment-blinded, were randomized to 1 of 3 Oxford medial UKA versions: cemented with double-pegged or single-pegged femoral component or cementless HA-coated with double-pegged femoral component (ratios 1:1:1). We compared wear between the cemented (n = 55) and cementless group (n = 25) (ratio 2:1). Wear, impingement, and overhang were quantified between surgery and 5-year follow-up using radiostereometry. Clinical outcome was evaluated with the Oxford Knee Score. Results - The mean wear-rate for patients without bearing overhang was 0.04 mm/year (95% CI 0.02-0.07) for the cemented group and 0.05 mm/year (CI 0.02-0.08) for the cementless group. The mean difference in wear was 0.008 mm/year (CI -0.04 to 0.03). No impingement was identified. Half of the patients had medial bearing overhang, mean 2.5 mm (1-5). Wear increased by 0.014 mm/year for each mm increment in overhang. The mean Oxford Knee Score was 39 for the cementless group and 38 for the cemented group at the 5-year follow-up. Interpretation - The wear-rates were similar for the 2 fixation methods, which supports further use of the cementless Oxford medial UKA. However, a caveat is a relatively large 95% CI of the mean difference in wear-rate. Component size and position is important as half of the patients presented with an additional increase in wear-rate due to medial bearing overhang.

Predictors of revision, prosthetic joint infection and mortality following total hip or total knee arthroplasty in patients with rheumatoid arthritis: a nationwide cohort study using Danish healthcare registers.

OBJECTIVES: To investigate predictors of 10-year risk of revision and 1-year risk of prosthetic joint infection (PJI) and death following total hip/total knee arthroplasty (THA/TKA) in (1) patients with rheumatoid arthritis (RA) compared with patients with osteoarthritis (OA); and (2) patients with RA treated with biological disease-modifying antirheumatic drugs (bDMARD) within 90 days preceding surgery compared with non-treated. METHODS: Register-based cohort study using the Danish National Patient Register, the DANBIO rheumatology register (RA-specific confounders and treatment episodes) and the Danish Hip and Knee Arthroplasty Registers. Survival analyses were used to calculate confounder-adjusted sub-HRs (SHR) and HRs. RESULTS: In total, 3913 patients with RA with THA/TKA were compared with 120 499 patients with OA. Patients with RA had decreased risk of revision (SHR 0.71 (0.57-0.89)), but increased risk of PJI (SHR=1.46 (1.13-1.88)) and death (HR=1.25 (1.01-1.55)). In DANBIO, 345 of 1946 patients with RA with THA/TKA had received bDMARD treatment within 90 days preceding surgery. bDMARD-treated patients did not have a statistically significant increased risk of revision (SHR=1.49 (0.65-3.40)), PJI (SHR=1.61 (0.70-3.69)) nor death (HR=0.75 (0.24-2.33)) compared with non-treated. Glucocorticoid exposure (HR=2.87 (1.12-7.34)) and increasing DAS28 (HR=1.49 (1.01-2.20)) were risk factors for mortality. CONCLUSION: Patients with RA had a decreased 10-year risk of revision while the risk of death and PJI was increased compared with patients with OA following THA/TKA. bDMARD exposure was not associated with statistically significant increased risk of neither PJI nor death in this study. Glucocorticoid exposure and increased disease activity were associated with an increased risk of death.

Incidence of hip and knee replacement in patients with rheumatoid arthritis following the introduction of biological DMARDs: an interrupted time-series analysis using nationwide Danish healthcare registers.

OBJECTIVES: To study the impact of the introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) and associated rheumatoid arthritis (RA) management guidelines on the incidence of total hip (THR) and knee replacements (TKR) in Denmark. METHODS: Nationwide register-based cohort and interrupted time-series analysis. Patients with incident RA between 1996 and 2011 were identified in the Danish National Patient Register. Patients with RA were matched on age, sex and municipality with up to 10 general population comparators (GPCs). Standardised 5-year incidence rates of THR and TKR per 1000 person-years were calculated for patients with RA and GPCs in 6-month periods. Levels and trends in the pre-bDMARD (1996-2001) were compared with the bDMARD era (2003-2016) using segmented linear regression interrupted by a 1-year lag period (2002). RESULTS: We identified 30 404 patients with incident RA and 297 916 GPCs. In 1996, the incidence rate of THR and TKR was 8.72 and 5.87, respectively, among patients with RA, and 2.89 and 0.42 in GPCs. From 1996 to 2016, the incidence rate of THR decreased among patients with RA, but increased among GPCs. Among patients with RA, the incidence rate of TKR increased from 1996 to 2001, but started to decrease from 2003 and throughout the bDMARD era. The incidence of TKR increased among GPCs from 1996 to 2016. CONCLUSION: We report that the incidence rate of THR and TKR was 3-fold and 14-fold higher, respectively among patients with RA compared with GPCs in 1996. In patients with RA, introduction of bDMARDs was associated with a decreasing incidence rate of TKR, whereas the incidence of THR had started to decrease before bDMARD introduction.