京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第22346号 / 医博第4587号 / 新制||医||1042(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 安達 泰治, 教授 森本 尚樹, 教授 福原 俊一 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM

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<p><strong>Background: </strong>Total joint arthroplasty (TJA) is considered the treatment of choice to alleviate pain and improve function of patients with osteoarthritis. However,recent evidence suggests that a significant proportion of patients continue to report pain, or worsening of their symptoms well after their joint replacement. We call this chronic pain “<em>phantom joint pain</em>” as it persists despite the fact hat the affected joint has been replaced.</p> <p>Chronic pain of neuropathic origin may be a consequence of surgery or in patients with osteoarthritis (OA); there may be a combination of nociceptive and neuropathic pain (NP) mechanisms. As there are no definitive physiological indicators for NP or gold standards for diagnosis, Guidelines on Neuropathic Pain Assessment advocate the use of screening tools to evaluate the patient’s pain experiences and potentially characterize various pain features.</p> <p>Despite suggestions that phantom joint pain post TJA is a common problem there is limited information about its prevalence among Canadians. To date there are no studies that have characterized neuropathic vs. non- neuropathic chronic pain features in a TJA population.</p> <p><strong>Purpose: </strong>The purpose of this work was to determine the<em> </em>prevalence of chronic pain following total hip (THA) or knee (TKA) arthroplasty, and to identify the proportion of the cohort with chronic pain whose symptoms suggested the pain was of neuropathic origin. In addition we evaluated the ability of the NP Subscale of the McGill pain questionnaire [NP-MPQ (SF-2)] to identify individuals with NP vs. Non NP in the TJA population.</p> <p><strong>Methods:</strong> A retrospective cohort study (2-4 years post joint replacement) of 148 participants with primary unilateral TJAidentified from a large joint arthroplasty database (n=1143). Chronic pain was defined as post surgical pain reported 6-12 months following surgery to be 3 or higher (out of 5) on the Oxford Hip/Knee Scores, and that pain was the same or worse than reported preoperatively. A postal survey was used to administer the NP-MPQ (SF-2)and the Self-Administered Leeds Assessment of Neuropathic Signs and Symptoms (S–LANSS) (1.5-3.5 years post TJA). S-LANSS was the “non reference standard” for classification of neuropathic pain. Human research ethics approvals from Sunnybrook Health Sciences Centre and McMaster University/Hamilton Health Sciences were obtained prior to the study.</p> <p><strong>Results</strong>: The response rate to the postal survey to identify those with chronic pain of neuropathic origin was 53%. Thirteen percent of individuals experienced chronic pain; among individuals with chronic pain, neuropathic subtype was found in 28% (S-LANSS ≥ 12) - 43% [NP-MPQ (SF-2) ≥ 0.91]. Receiver Operating Characteristic (ROC) analysis for NP-MPQ (SF-2) yielded an area under the curve of 0.89 (95% CI: 0.82, 0.97). A cut off score of 0.91 NP-MPQ (SF-2),<strong> </strong>maximized sensitivity (89.5%) and specificity (75.0%). Our results revealed moderate correlation (r=0.56; 95% CI: 0.40, 0.68) between the S-LANSS and NP-MPQ (SF-2)scores in patients with NP post TJA.</p> <p><strong>Conclusion: </strong>Based on our results, a considerable percentage of individuals (13%) experience chronic pain following TKA and THA. Moreover, among individuals with chronic pain symptoms, a significant proportion (28-43%) of those experience pain that appears to have a neuropathic component, even 1.5 to 3.5 years following surgery.Overall prevalence of NP in TJA was 3.3 to 4.5%. The NP-MPQ (SF-2)subscale demonstrated “good” discriminatory ability, thus it might be useful in identifying patients with NP following TJA. Moderate association exists between the scales and this could affect prevalence rates in studies; or diagnosis of NP of individual patients based on the criterion used.</p> / Master of Science (MSc)

Die Implantation von Knieendoprothesen ist ein orthopädisches Standardverfahren und bereits seit vielen Jahren etabliert. Sowohl in Deutschland als auch international nimmt sie einen hohen sozioökonomischen Stellenwert ein. Mögliche Komplikationen stellen daher eine persönliche Belastung für den Patienten, aber auch eine Belastung für das Gesundheitssystem dar. Um eine Nachverfolgung und Dokumentation deutschlandweit vorzunehmen wurde eine externe Qualitätssicherung etabliert. In dieser Arbeit werden Daten der externen Qualitätssicherung mit Studiendaten aus dem Orthopädisch-Unfallchirurgischen Zentrum der Universitätsklinik Dresden verglichen um der Fragestellung nachzugehen ob und wie viele unerwünschte Behandlungsfolgen über den stationären Aufenthalt bzw. die externe Qualitätssicherung hinaus auftreten.:1. Einleitung 6 1.1. Historische Entwicklung 6 1.2. Epidemiologie und heutiger Wissensstand 7 1.3. Entwicklung der Qualitätssicherung 14 1.4. Qualitätssicherung / Qualitätsmanagement in der Medizin 16 1.5. Fragestellung 18 • Hypothese: Es wird angenommen, dass in Studien nicht mehr unerwünschte Behandlungsfolgen im Rahmen des stationären Aufenthaltes erfasst werden als in der externen Qualitätssicherung. 19 • Weiterhin zu bearbeitende Fragestellungen dieser Arbeit sind: 19 2. Material und Methoden 20 2.1. Patientenkollektiv 20 2.2. Ethik 22 2.3. Datenerfassung 23 2.4. Komplikationen 23 2.5. Methoden der statistischen Auswertung 29 3. Ergebnisse 30 3.1. Patientencharakteristika der Studienpopulation 30 3.2. Auswertung der Fragestellungen 38 • 3.2.1. Zur Hypothese: Welche Daten wurden im Rahmen der Studien erfasst und welche Daten wurden über die externe Qualitätssicherung gemeldet? 38 • 3.2.2. Zu den weiterhin bearbeiteten Fragestellungen: 54 4. Diskussion 62 4.1. Zur Hypothese: Es wird angenommen, dass in Studien nicht mehr unerwünschte Behandlungsfolgen im Rahmen des stationären Aufenthaltes erfasst werden als in der externen Qualitätssicherung. 64 4.2. Zu den weiterhin bearbeiteten Fragestellungen: 66 4.3. Ausblick 72 4.4. Limitationen der Studie 74 5. Zusammenfassung 75 6. Summary 77 7. Literatur 79 8. Abbildungsverzeichnis 85 9. Tabellenverzeichnis 87 10. Abkürzungsverzeichnis 88 11. Anhang 92 11.1. Ethikvoten für die zugrundeliegenden Studien 92 11.2. Nachuntersuchungsdokumente der Studien 105 11.3. Danksagung 109 11.4. Anlagen 110 / The total knee arthroplasty is a standard orthopedic procedure which has been established for many years, both in Germany and internationally. Possible complications therefore represent a personal burden for the patient and also for the healthcare-system. In order to carry out tracking and documentation, an external quality assurance was established. In this thesis, data from external quality assurance are compared with study data from the Orthopaedic Trauma Surgery Centre of the University Hospital Dresden in order to investigate the question of whether and how many adverse events occur beyond the inpatient stay or external quality assurance.:1. Einleitung 6 1.1. Historische Entwicklung 6 1.2. Epidemiologie und heutiger Wissensstand 7 1.3. Entwicklung der Qualitätssicherung 14 1.4. Qualitätssicherung / Qualitätsmanagement in der Medizin 16 1.5. Fragestellung 18 • Hypothese: Es wird angenommen, dass in Studien nicht mehr unerwünschte Behandlungsfolgen im Rahmen des stationären Aufenthaltes erfasst werden als in der externen Qualitätssicherung. 19 • Weiterhin zu bearbeitende Fragestellungen dieser Arbeit sind: 19 2. Material und Methoden 20 2.1. Patientenkollektiv 20 2.2. Ethik 22 2.3. Datenerfassung 23 2.4. Komplikationen 23 2.5. Methoden der statistischen Auswertung 29 3. Ergebnisse 30 3.1. Patientencharakteristika der Studienpopulation 30 3.2. Auswertung der Fragestellungen 38 • 3.2.1. Zur Hypothese: Welche Daten wurden im Rahmen der Studien erfasst und welche Daten wurden über die externe Qualitätssicherung gemeldet? 38 • 3.2.2. Zu den weiterhin bearbeiteten Fragestellungen: 54 4. Diskussion 62 4.1. Zur Hypothese: Es wird angenommen, dass in Studien nicht mehr unerwünschte Behandlungsfolgen im Rahmen des stationären Aufenthaltes erfasst werden als in der externen Qualitätssicherung. 64 4.2. Zu den weiterhin bearbeiteten Fragestellungen: 66 4.3. Ausblick 72 4.4. Limitationen der Studie 74 5. Zusammenfassung 75 6. Summary 77 7. Literatur 79 8. Abbildungsverzeichnis 85 9. Tabellenverzeichnis 87 10. Abkürzungsverzeichnis 88 11. Anhang 92 11.1. Ethikvoten für die zugrundeliegenden Studien 92 11.2. Nachuntersuchungsdokumente der Studien 105 11.3. Danksagung 109 11.4. Anlagen 110

La pose d’une prothèse totale de genou (PTG) se fait selon la technique d’alignement mécanique (AM) qui corrige les déformations constitutionnelles du membre pour créer un membre rectiligne. La survie à long terme des implants est excellente mais les résultats fonctionnels sont décevants avec notamment de nombreux symptômes résiduels. Une nouvelle technique chirurgicale, l’alignement cinématique (AC), vise à rétablir l’anatomie constitutionnelle pré-arthrosique du genou, et permet une amélioration des résultats fonctionnels des PTG. Cette technique est actuellement réalisée avec des implants destinés à un positionnement mécanique, et qui ont un design trochléen ne reproduisant pas l'anatomie trochléaire native. Ceci pourrait affecter la biomécanique de l’articulation patello-fémorale et donc rendre les résultats fonctionnels des PTG cinématiques non optimal. Ce travail vise à démontrer 1) les limitations de la technique mécanique, 2) la fiabilité de la technique cinématique pour le positionnement de l’implant fémoral, et 3) que les implants actuels ne permettent pas une restauration de l’anatomie trochléenne des patients. / The conventional technique for TKA, namely mechanical alignment (MA), does not preserve the constitutional limb anatomy but systematically creates a straight limb. Excellent long-term implant survivorship has been reported, but functional outcomes are disappointing. To solve this problem, an alternative technique for TKA, namely kinematic alignment (KA), has recently been promoted and aims at restoring the constitutional (pre-arthritic) knee anatomy and laxity. Mid-term outcomes have shown excellent functional outcomes with this new KA technique. However, KA technique is currently done with TKA implants designed to be mechanically inserted. Their trochlea design does not reproduce the native trochlear anatomy, which could lead to increased rate of patellar complications with KA TKA. This work aims at demonstrating technical limitations of MA technique, good reproducibility of KA technique, and inappropriateness of current implant to restore patient trochlea anatomy.

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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-sewtime), 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.

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.clini caltr ials. gov) registry under NCT00862511.

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