Identification of Potentially High-risk Patients on the Basis of PROMs in a Certified Centre for Joint Replacement (EndoProthetikZentrum) Using the Example of Primary Knee Arthroplasty. / Identifikation von potenziellen Risikopatienten auf Basis von PROMs in einem zertifizierten EndoProthetikZentrum am Beispiel der primären Knieendoprothetik.

BACKGROUND: The subjective evaluation of the patient's state of health with the help of Patient-reported Outcome Measurements (PROMs) provides valuable information for assessing the treatment outcome and for treatment planning. However, the use of PROMs in the field of arthroplasty is not mandatory, so that there is a lack of standardised recording and interpretation. The present study aims to identify patients, who have not achieved the intended treatment goals with regard to pain, function and quality of life after total knee arthroplasty, more easily in the future on the basis of postoperative PROMs. MATERIAL AND METHODS: Data collection (for 3-month postoperative follow-up) included a standardised clinical follow-up (NU) and a questionnaire of different PROMs (Oxford Knee Score [OKS], OKS Pain Score [OKSS] and EndoCert Risk Score [ERS]). During the specialist follow-up examination, it was decided whether further medical therapy had to be initiated. Accordingly, patients were grouped into four post-treatment categories (NU not required/further diagnostics/new prescription/revision required). RESULTS: For individual scores and questions, there were significant differences between the respective groups of consequences resulting from the follow-up examination. The OKS, OKS Pain Score and the ERS are suitable for detecting thresholds to determine the need for a follow-up examination. The postoperative thresholds of the scores are 24 for the OKS total score, 52 for the OKS pain score and 4 for the ERS pain intensity score. CONCLUSION: In the initial three months after knee arthroplasty, certain PROMs are suitable for identifying patients for whom further diagnostics and therapy are indicated. In particular, the OKS and the pain intensity score of the ERS are suitable for detecting a potentially unfavourable development in rehabilitation after total knee arthroplasty.

Identification of Potential High-Risk Patients on the Basis of PROMs in a Certified Centre for Joint Replacement (EndoProthetikZentrum) Using the Example of Hip Arthroplasty. / Identifikation von potenziellen Risikopatienten auf Basis von PROMs in einem zertifizierten EndoProthetikZentrum am Beispiel der Hüftendoprothetik.

BACKGROUND: In addition to clinical parameters, the subjective assessment by the patient to evaluate the operative outcome of an arthroplasty is becoming increasingly important. Questionnaires are used to identify patients who have not achieved the treatment goal at an early stage so that further interventions can be indicated. MATERIAL AND METHODS: A questionnaire consisting of different PROMs was completed pre- and 3 months postoperatively by patients who had been treated with a hip arthroplasty. A standardised follow-up examination of these patients was carried out 12 to 16 weeks postoperatively, after which it was determined whether further therapy was necessary to achieve the treatment goal. Different consequences were defined for this. RESULTS: Significant differences were found between the groups of consequences of follow-up examinations over both time points, but also when postoperative scores were considered exclusively. Furthermore, the correlations for the postoperative scores and some consequences of the clinical follow-up for the Oxford Hip Score (OHS), the OHS functional score and the Euroquol-5D show moderate effects. Thus, the collection of these postoperative scores is sufficient to identify potential high risk patients. Based on a receiver operating characteristic (ROC) analysis, threshold values could be determined for these scores, for which a follow-up examination is recommended. CONCLUSION: Patients who could not achieve functional improvement, pain reduction and improvement in quality of life after implantation of a total hip replacement must be identified at an early stage. The results of our study show that with the help of the Oxford Hip Score and Euroquol-5D, which are answered by the patients three months postoperatively, such high risk patients can be identified. This finding is an added value for the further development of the EndoCert certification system and holistic quality assurance in arthroplasties, while the personnel and time effort remain manageable.

[Continuous Passive Motion in Orthopaedic Rehabilitation of the Shoulder Girdle - A Literature Survey]. / Kontinuierliche passive Bewegungstherapie (CPM-Therapie) in der orthopädischen Rehabilitation am Schultergelenk ­ eine Literaturübersicht.

BACKGROUND: Continuous passive motion (CPM) of the shoulder is predominantly used during postoperative rehabilitation of the shoulder girdle. It is often used after rotator cuff repair (RM suture). Incapacity to work and therapy of shoulder diseases cause significant costs for the healthcare system in Germany. METHODS: In a literature analysis, studies and reviews of the CPM treatment in scientific databases were therefore identified and analysed with regard to the functional outcome particular after shoulder joint surgery. The quality of the studies was evaluated using the Cochrane Collaboration's Risk of Bias Tool. RESULTS: After rotator cuff suturing, clinical studies have predominantly shown a faster improvement in pain level and shoulder mobility when using CPM treatment compared to other forms of treatment. In the case of frozen shoulder, only studies with the scope of CPM in conservative treatment could be identified. Here predominantly faster pain reduction could be observed. Studies addressing CPM in the therapy of Impingement of the shoulder, fracture of the humeral head or arthroplasty of the glenohumeral joint could not be identified. The health economic effects of CPM use are controversially discussed. In the available studies, equipment and other costs are assessed differently. CONCLUSION: The analysed clinical studies showed overall positive effects, e. g. a faster improvement of pain level and shoulder mobility, in the postoperative therapy of the shoulder after rotator cuff repair as well as in the conservative therapy of shoulder stiffness for the CPM treatment compared to other forms of treatment. For other entities no meaningful studies are available in the literature to date. Since the health economic effects of the use of CPM have been discussed controversial so far, potential health economic benefits of the use of CPM treatment should be evaluated in future studies.

A biodegradable stent based on poly(L-lactide) and poly(4-hydroxybutyrate) for peripheral vascular application: preliminary experience in the pig.

PURPOSE: To assess the technical feasibility and biocompatibility of a novel stent based on poly(L-lactide) (PLLA) and poly(4-hydroxybutyrate) (P4HB) for peripheral vascular applications. METHODS: A polytetrafluoroethylene aortobi-iliac graft was implanted in 5 pigs through a midline abdominal incision. After transverse graft limb incision, 5 PLLA/P4HB stents and 5 metal stents (316L stainless steel) were randomly deployed at both iliac anastomotic sites with 6-mm balloon catheters. Angiography was performed to determine patency prior to sacrifice at 6 weeks. Stented segments were surgically explanted and processed for quantitative histomorphometry. Vascular injury and inflammation scores were assigned to the stented iliac segments. RESULTS: No animals were lost during follow-up. All PLLA/P4HB stents were deployed within 2 minutes by balloon inflation to 8 bars without rupture of the stent struts or anastomotic suture. All stents were patent on postprocedural angiography. Histological analysis showed no signs of excessive recoiling or collapse. PLLA/P4HB stents demonstrated decreased residual lumen area and increased neointimal area after 6 weeks (12.27+/-0.62 and 8.40+/-1.03 mm(2), respectively) compared to 316L stents (13.54+/-0.84 and 6.90+/-1.11 mm(2), respectively) as the result of differences in stent areas (PLLA/P4HB: 4.31+/-0.15 mm(2); 316L: 2.73+/-0.29 mm(2)). Vascular injury scores showed only mild vascular trauma for all stents (PLLA/P4HB: 0.41+/-0.59; 316L: 0.32+/-0.47). Inflammatory reaction was slightly higher around PLLA/P4HB stent struts (1.39+/-0.52) compared to 316L (1.09+/-0.50). CONCLUSION: Rapid balloon expansion of PLLA/P4HB stents is feasible without risk of strut rupture. PLLA/P4HB stents provide adequate mechanical stability after iliac anastomotic stenting in pigs. Smaller residual luminal areas in the PLLA/P4HB stents might have been caused by tissue ingrowth into the larger strut interspaces due to higher strut thickness (stent area) in this group. This limitation needs to be addressed in future work on the stent design.

Iliac anastomotic stenting with a sirolimus-eluting biodegradable poly-L-lactide stent: a preliminary study after 6 weeks.

PURPOSE: To assess technical feasibility and biocompatibility of a new biodegradable sirolimus-eluting poly-L-lactide (PLLA) vascular anastomotic stent. METHODS: A polytetrafluoroethylene bifurcated graft was implanted in 9 pigs through a midline abdominal incision. After transverse graft limb incision, 6 unloaded PLLAs, 6 sirolimus-loaded PLLAs, and 6 unloaded stainless steel (316L) stents were randomly implanted at both iliac anastomotic sites. Stents were deployed with a 6-mm balloon under direct vision without the use of angiography. Prior to sacrifice after 6 weeks, contrast-enhanced computed tomography (CT) was performed to determine patency of the target vessels. Stented segments were surgically explanted and processed for histology to measure the mean luminal diameter and intimal thickness and to assign vascular injury and inflammation scores. RESULTS: No animals were lost during the study period. All stented graft limbs were patent on CT and histology. At the anastomotic sites and iliac arteries, the mean luminal diameter of SIR-PLLA stents (4.11+/-0.15 and 4.08+/-0.13 mm, respectively) were comparable to metal stents (4.23+/-0.35 and 4.21+/-0.26 mm, respectively), but significantly higher compared to unloaded PLLA stents [3.32+/-0.56 mm (p<0.001) and 3.29+/-0.39 mm (p=0.013), respectively]. At the iliac arteries, the mean intimal thickness was significantly lower with SIR-PLLA stents (0.09+/-0.02 mm) compared to unloaded PLLA stents (0.31+/-0.15 mm, p<0.001) and metal stents (0.19+/-0.04 mm, p=0.004). Vascular injury scores demonstrated only mild vascular trauma for all stents (SIR-PLLA: 0.42+/-0.63, PLLA: 0.51+/-0.62, metal: 0.50+/-0.62). Only mild inflammatory reaction was noted around SIR-PLLA stent struts (1.14+/-0.46), which was comparable to metal stents (1.27+/-0.45) but significantly lower than PLLA stents (1.79+/-0.56, p<0.001). CONCLUSION: SIR-PLLA stents showed comparable luminal diameter compared to metal stents, so incorporating sirolimus could reduce the inflammatory and neointimal response to PLLA stents. These findings need to be assessed with longer follow-up to confirm maintenance of efficacy.