[Validated German PROMs for People with Major Amputation of the Lower Extremity - A Narrative Review Based on the Final Report of the LEAD and COMPASS Initiative of the ISPO]. / Validierte deutschsprachige PROMs für Menschen mit Majoramputation der unteren Extremität ­ Ein narrativer Review anhand des Abschlussreports der LEAD- und COMPASS-Initiative der ISPO.

Patient-reported outcome measures (PROMs) play an important role in the rehabilitation of people with major limb amputations. Patient-completed questionnaires help collect specific constructs on this patient population. The COMPASS and LEAD initiatives, carried out by the International Society for Prosthetics and Orthotics (ISPO), underscore the importance of regularly collecting high-quality PROMs. These are essential for the evaluation of rehabilitation needs, progress, and success. In the final report of ISPO's major international initiative, PROMs recommendations of the expert panel are tabulated. In Table 3.2 of the report, ISPO lists n=12 PROMs that were included in the narrow consensus process were considered to be of acceptable quality, and therefore recommended. The aim of this systematic review was to specifically search for these recommended PROMS regarding their availability in a German and validated version in order to identify potential gaps. All PROMs that were available in a German and validated version were then examined further with regard to the quality of the validation study, using the checklist of COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Through a systematic literature search, six validated German-language versions were found. Only four of these met the quality standards of the COSMIN checklist sufficiently. Overall, this review shows serious gaps in the availability in the German language of validated versions of PROMs used internationally and recommended as standard by the ISPO. This gap needs to be closed by guideline-oriented translation and subsequent validation studies in order to be able to offer and collect the PROMS recommended by the ISPO also for German-speaking patient populations.

Effects of acupuncture and medical training therapy on depression, anxiety, and quality of life in patients with frequent tension-type headache: A randomized controlled study.

OBJECTIVES: To compare the effects of acupuncture and medical training therapy in combination or individually with usual care on quality of life, depression, and anxiety in patients with tension-type headache. METHODS: In this single-center, prospective, randomized, controlled, unblinded trial, 96 adults (38.7(+/-13.3) years of age; 75 females/20 males/one dropout) with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups (n = 24). The treatment groups received six weeks of either acupuncture or medical training therapy as monotherapies or in combination (12 interventions each), or usual care. We assessed depressiveness (PHQ-9), anxiety (GAD-7), and health-related quality of life (SF-12) as secondary outcome parameters at baseline, six weeks, three months, and six months after initiation of treatment. Linear mixed models were calculated. RESULTS: Both, acupuncture (baseline to six-weeks change scores: mean: -2(standard deviation: 2.5 points), three months: -2.4(2.4), six-months -2.7(3.6)) and the combination of acupuncture and medical training therapy (-2.7(4.9), -2.2(4.0), -2.2(4.2)) (each within-group p < .05) significantly reduced depressiveness-scores (PHQ-9) to a greater extent than medical training therapy (-0.3(2.0), -0.5(1.6), -0.9(2.6)) or usual care alone (-0.8(2.9), 0.1(2.8), 0.2(3.6)). We found similar results with anxiety scores and the physical sum scores of the SF-12. No severe adverse events occurred. CONCLUSIONS: Acupuncture and the combination of acupuncture and medical training therapy elicit positive effects on depression, anxiety, quality of life, and symptom intensity in patients with episodic and chronic tension-type headache. Acupuncture appears to play a central role in mediating the therapeutic effects, underscoring the clinical relevance of this treatment. An additive benefit of the combination of both therapies does not appear to be relevant.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.

Rasch validation of the German translation of the Prosthetic Limb Users Survey of Mobility short forms in people with lower limb amputation.

BACKGROUND: Prostheses are a primary rehabilitative intervention for people after lower limb amputation. To appropriately measure the effectiveness of prosthetic interventions, valid and reliable measures of prosthetic mobility are required. The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a promising instrument for measuring prosthesis users' mobility. However, German translations of the PLUS-M short forms have not yet been validated. OBJECTIVES: Rasch validation of the German translation of the PLUS-M short forms in people with lower limb amputation. STUDY DESIGN: This study is based on a cross-sectional survey of prosthesis-using lower limb amputees from a nation-wide cohort. METHODS: PLUS-M data (the 7-item and the 12-item shortforms; PLUS-M-7 and PLUS-M-12, respectively) from 194 lower limb prosthesis users were subjected to Rasch analysis, an advanced statistical method for assessing if the measurement properties of a questionnaire comply with a wide spectrum of psychometric requirements. RESULTS: Analysis showed appropriate rating scale functioning, good internal construct validity (item fit), unidimensionality, and good targeting of the PLUS-M-7 and PLUS-M-12 short forms. Moreover, the greater conditional measurement precision of PLUS-M-12 (regarding higher test information and lower standard error of mobility estimates) was quantified. CONCLUSIONS: Rasch analysis of the German translation of both PLUS-M short forms showed good psychometric qualities. In addition, our study showed that test scores from the PLUS-M-12 are more accurate. Therefore, the PLUS-M-12 is recommended for individual-level clinical applications (e.g., classification or change assessment).

Validity and Reliability of the German Version of the Locomotor Capabilities Index-5 (LCI-5).

BACKGROUND: Before foreign language questionnaires, such as patient reported outcome measures (PROMs), can be scientifically used in the national language, guideline-based translation, cultural adaptation and comprehensive verification of their validity and reliability are needed. The aim of this study was to assess the psychometric properties of the German version of the LCI-5 (LCI-5-D) on a sample of people with lower limb amputation (LLA). METHODS: The LCI-5 was translated into German (LCI-5-D) based on the ISPOR guidelines for cross-cultural adaptation following pilot testing. The final LCI-5-D was administered to n = 52 lower limb amputees in order to determine the validity and reliability of both the total score and the subscores ("basic items" and "advanced items"). Internal consistency (Cronbach's alpha), test-retest reliability (ICC2,1), standard error of the mean (SEM), minimal detectable change (MDC), item-to-total correlation, and item-to-subscale correlation were calculated. Floor and ceiling effects were checked. For construct validity, the Rivermead Mobility Index (RMI) and timed up and go (TUG) test were correlated, and differences of defined subgroups (amputation height and prosthesis user type) were calculated. RESULTS: On average, the score of the LCI-5-D was 40.13 ± 16.64 points. High ceiling effects were present for the subscale "basic items" (57.7% maximum score). Internal consistency showed excellent results (Cronbach's α = 0.97). A strong correlation to the RMI (r = 0.863; p < 0.001) and to the TUG (r = - 0.714; p < 0.001) demonstrated construct validity. Test-rest reliability was measured after an averaged time span of 5.3 ± 2.47 days and resulted in very high reliability [ICC (2,1) = 0.97; p < 0.001]. MDC was 7.57 points for the total score. CONCLUSION: The LCI-5-D is a valid and reliable PROM for measuring mobility with prostheses in German-speaking lower limb amputees, which is rather suitable for people with low to moderate mobility abilities. It can be used in a German-speaking population.

[Electrotherapeutical stellate ganglion block on a patient with complex regional pain syndrome of the upper limb]. / Elektrotherapeutische Stellatumblockade bei einer Patientin mit komplexem regionalem Schmerzsyndrom der oberen Extremität.

The case of a 51-year-old patient with complex regional pain syndrome (CRPS) of the left hand after radius distortion is reported. Anticonvulsant therapy was difficult in this case due to persisting epilepsy with already dual therapy (lamotrigine and brivaracetam) at high dosage. With existing neuropathic pain, pronounced allodynia and hyperhidrosis, repetitive transcutaneous monophasic electrotherapy was applied above the stellate ganglion. A ganglion blockage could not be clinically confirmed in the absence of Horner syndrome, but neuropathic pain and hyperhidrosis could be positively influenced. This case report summarizes the electrode positions used, current parameters, pitfalls and therapy limitations and discusses them in relation to the literature.

Osseoperception in transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation: a prospective study.

BACKGROUND: Endo-exo prosthetics (EEP), which belongs to the transcutaneous osseointegrated prosthetic systems (TOPS), provides an alternative bone-anchored rehabilitation method for transfemoral amputees. It led to the question of whether transmitted forces from prosthetic feet are perceptible by osseoperception resulting in proprioceptive feedback of ground conditions. OBJECTIVES: The following hypotheses emerged for our trial with the null hypothesis: EEP fitting after transfemoral amputation does not influence osseoperception. Alternative hypothesis 1: EEP patients achieve better osseoperception results than transfemoral amputees fitted with socket prosthesis. Alternative hypothesis 2: EEP carriers achieve comparable results with regards to their osseoperception as non-amputees. METHODS: N = 25 patients with EEP (mean age = 50,6 ± 9,4, male/female = 15/10) N = 25 patients with socket prostheses (mean age = 52,6 ± 13,1, male/female = 19/6) and N = 25 healthy volunteers were included in the experimental case-control study. In three blinded test modules (V1, V2, V3), the participants had to identify different degrees of shore hardness (c) of different materials (rubber balls (shore = 5-25c), foam cushions (shore = 5-30c), foam mats (shore = 5-30c) with their prosthetic foot (or a personally defined foot in healthy volunteers) without footwear and had to rank them into the correct order according to their tactile sensation and the degree of hardness. A maximum of 10 points could be scored per run. RESULTS: This experimental observational study included N = 75 participants. The mean age for the entire cohort was 42.8 ± 16.6 years and the BMI was 26.0 ± 4.8. Our results show a significant level of differences in tactile osseoperception between all groups (p < 0.001). A correlation between the mean values of V1-3 and the PMQ2.0 as well as the mean values of K-Level and the prosthesis wearing time per day showed for PMQ (r = 0.387, p = 0.006) and K-level (r = 0.448, p = 0.001) which is a moderate effect according to Cohen. CONCLUSION: Our study results suggest that the EEP treatment can lead to an improvement in tactile sensory perception via the bone-anchored implant, which can lead to an increase in quality of life and improved gait safety.

Twenty-four months of bacterial colonialization and infection rates in patients with transcutaneous osseointegrated prosthetic systems after lower limb amputation-A prospective analysis.

Background: Transcutaneous osseointegrated prosthesis systems (TOPS) are alternative rehabilitation methods to socket prosthetics, after limb amputation. TOPS compromise a two-step surgery: starting with the implantation of the stem which is then followed by the creation of the transcutaneous stoma through which the exoprosthesis can be connected. Immediately after surgery, this opening is permanently exposed to pathogens. This study aimed to investigate the dynamics of bacterial colonization of the stoma to analyze whether obligate bacterial colonization leads to a risk of periprosthetic infections after TOPS treatment. Methods: This prospective study analyzed data from 66 patients (aged 26-75 years) after TOPS treatment between 2017 and 2019. Microbiological swabs from the stoma were analyzed on the first postoperative day and 3, 6, 12, and 24 months after stoma creation. Infection rates, laboratory values (CRP, leukocyte count, hemoglobin), and body temperature were recorded at these points in time. Statistical analysis was performed using SPSS 28. Results: The results show the formation of a stable environment dominated by Gram-positive bacteria in the stoma of TOPS patients over 24 months. Staphylococcus aureus, Staphylococcus spp., and Streptococcus spp. were the most common species found. With regard to the cohort up to the 3 months follow-up, 7.9% (five patients) developed infections surrounding the TOPS procedure. In relation to the whole cohort with loss to follow-up of 80.3% at the 24 months follow-up the infection rates increased up to 38.3%. Conclusion: The soft tissue inside and around the transcutaneous stoma is colonialized by multiple taxa and changes over time. A stable Gram-positive dominated bacterial taxa could be a protective factor for ascending periprosthetic infections and could possibly explain the relatively low infection rate in this study as well as in literature.

Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation.

PURPOSE: The aim of this retrospective analysis was to investigate and evaluate differences in functional outcome and satisfaction of patients treated with a TOPS and patients using socket prosthesis after transfemoral amputation. METHODS: This retrospective comprehensive analysis included patients from a single hospital, and was conducted between February 2017 and December 2018. Overall n = 139 patients with prosthesis were included and divided into two comparable groups (socket- and TOPS group). Incomplete data sets were excluded. This led to n = 36 participants for the socket- and n = 33 for the TOPS group. Functional outcome and satisfaction were evaluated by Patient Reported Outcome Measures (PROMs). The used PROMs were: Questionnaire for Persons with a Transfemoral Amputation (Q-TFA), EQ5D-5L, Satisfaction with Prosthesis Questionnaire (SAT-PRO), Prosthesis Mobility Questionnaire (PMQ 2.0) and Functional Independence Measure (FIM). RESULTS: Significant results in favor of TOPS patients were identified for the EQ-5D 5L (p = 0.004), Q-TFA (p = 0.000), SAT-PRO (p = 0.000) and PMQ 2.0 (p = 0.000). For FIM, no statistical significance was found (p = 0.318). CONCLUSION: In this study, transfemoral amputees treated with an osseointegrated prosthetic attachment (TOPS) showed significantly higher scores for mobility and satisfaction. This demonstrates the high potential of TOPS in the prosthetic treatment of patients with transfemoral amputation with regard to their functional abilities in daily life.

Management, outcome, and novel classification system of periprosthetic fractures in patients with transcutaneous osseointegrated prosthetic systems (TOPS)-a retrospective cohort analysis.

INTRODUCTION: Transcutaneous osseointegrated prosthetic systems (TOPS) are anchored prosthetic systems for major limb loss. Sometimes TOPS patients suffer from periprosthetic fractures. The aim of this study was to analyze the management and outcomes of periprosthetic fractures in patients with TOPS and to introduce a novel classification system for this entity. MATERIAL/METHODS: Since 2010, 140 patients were treated with TOPS after transfemoral amputation in two centers in Germany. Fifteen patients sustained periprosthetic fractures, with five intra- and ten postoperative fractures. The outcome was analyzed by Prosthesis Mobility Questionnaire (PMQ), K-level and prosthesis wear time per day. A subgroup analysis for the body mass index (BMI) was performed. RESULTS: All postoperative fractures were treated with implant-retaining osteosynthesis. Fourteen fractures healed without complications after a mean of 3 months. One postoperative fracture developed a clinically asymptomatic firm non-union. No Endo-Fixstem had to be removed. For the fracture and control group, a significant increase of the PMQ (p < 0.001) and K-level (p < 0.001) was observed after TOPS treatment compared to the preoperative baseline. Furthermore, the subgroup analysis showed a significant increase of the PMQ and K-level for both normal weight (p = 0.002) and overweight patients (p < 0.001). Of interest, overweight patients even showed a significantly higher increase in scores compared to normal weight patients, regardless of periprosthetic fracture. CONCLUSION: Periprosthetic fractures do not necessarily worsen outcomes of TOPS treatment. Proper classification and standardized appropriate treatment strategies according to fracture morphology are paramount for reliably good outcomes. We recommend to not remove or exchange the implant (Endo-Fixstem) even if it is assembly. Higher BMI did not have an impact onto rehabilitation success after TOPS to major limb loss of the lower extremity.

[Physical therapy in the treatment of complex regional pain syndrome]. / Physikalische Therapie in der Behandlung des komplexen regionalen Schmerzsyndroms.

The treatment of patients with complex regional pain syndrome (CRPS) takes place in an interdisciplinary and multimodal setting. Physical therapies represent a major treatment focus along with physiotherapy, occupational therapy, and analgetic treatments. This review explains their importance in current clinical practice and gives an impression of the evidence on different treatments including electrotherapy, neuromodulating procedures, manual lymphatic drainage, CO2 applications and paraffin wax baths. As far as ascertainable from clinical experience and the scientific literature, treatment recommendations are presented in accordance with current guidelines.

[Translation, Adaptation, Reliability and Validity of the German Version of the Prosthesis Mobility Questionnaire 2.0 (PMQ) on Patients with Major Lower Limb Amputation]. / Übersetzung und transkulturelle Adaptation des Prosthesis Mobility Questionnaire 2.0 (PMQ) ins Deutsche und dessen Reliabilität und Validität bei Patienten mit Majoramputation der unteren Extremität.

PURPOSE: The aim of this prospective validation study was to translate the Prosthesis Mobility Questionnaire 2.0 (PMQ) into German based on a guideline, following by psychometric testing for its validity and reliability using classical test theory. METHODS: The PMQ was translated into German according to ISPOR guidelines using double forward and double backward translations, finalized by pilot testing (N=10). Subsequently, assessment of the validity and reliability was performed from March 2020 to August 2020 on N=61 patients with unilateral lower limb amputation. Construct validity was determined by using the German version of the Locomotor Capabilities Index-5 (LCI-5-D), the Rivermead Mobility Index (RMI), the Timed up and go Test (TUG), and K-levels. Cronbach's alpha was calculated to check internal consistency and discriminatory power was determined by item correlations. Test-retest reliability was calculated using ICC (2,1). Based on the ICC, the minimum detectable difference (MDC) was calculated. RESULTS: The translation process required small changes after the pilot test. The validation study was performed on N=61 patients (56.59±13.16 years, m/f=38/23). A mean PMQ of 26.23±8.89 points was achieved. Ceilings or floor effects for total score did not appear. Construct validity showed strong positive correlations to LCI-5-D (r=0.74, p<0.001), RMI (r=0.63 p<0.001) as well as k-levels (r=0.61 p<0.001) and moderate negative correlation to TUG (r=- 0.49, p<0.001). Internal consistency was excellent with Cronbach's alpha=0.95). All items showed a value greater than r=0.40 for item-to-total score correlation. Test-retest reliability was excellent with an ICC (2,1)=0.98 with a timespan between T0 and T1 of 3.2±2.83 days. Based on this results, the MDC was 3.40 points. CONCLUSION: The German version of the Prosthesis Mobility Questionnaire 2.0 is a valid, reliable patient reported outcome measure (PROM) for measuring mobility and functional ability of patients with exoprosthesis due to unilateral lower limb amputation. It can be used for a German-speaking population.

The Flexor Pollicis Longus Reflex: Interrater and Intrarater Reliability in Comparison With Established Muscle Stretch Reflexes.

OBJECTIVE: The aim of this study was to investigate the interrater reliability and intrarater reliability of the flexor pollicis longus muscle stretch reflex (FPLR) and compare it with clinically established reflexes. DESIGN: A total of 71 healthy volunteers participated. The FPLR, biceps reflex, brachioradialis reflex, and patellar tendon reflex of each participant were tested bilaterally and rated by eight examiners (four experienced, four inexperienced). For intrarater reliability evaluation, five examiners rated the reflexes of four volunteers at four different points in time. RESULTS: Analysis of the interrater reliability with Gwet's AC1 demonstrated almost perfect agreement for FPLR (Gwet's AC1 = 0.90), biceps reflex (Gwet's AC1 = 0.90), and patellar tendon reflex (Gwet's AC1 = 0.95) when using binary data (reflex present vs. absent). Only fair agreement was found for the brachioradialis reflex (Gwet's AC1 = 0.56). Experienced raters had a higher agreement than inexperienced raters did when rating the biceps reflex and the patellar tendon reflex. The intrarater reliability was almost perfect for the patellar tendon reflex (Gwet's AC1 = 0.94), followed by the FPLR (Gwet's AC1 = 0.83) with substantial agreement and the biceps reflex (Gwet's AC1 = 0.57) with moderate agreement. CONCLUSION: The FPLR is a reliable diagnostic neuromuscular test and may therefore be useful in the clinical examination for C8/T1 nerve root lesions or pathologies of the interosseous anterior nerve. TO CLAIM CME CREDITS: Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME. CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) Elicit the flexor pollicis longus muscle stretch reflex; (2) Discuss the disadvantage of kappa statistics in assessing the interrater reliability when the prevalence of the studied trait is very high or very low; and (3) Name the spinal nerves involved in the innervation of the flexor pollicis longus muscle. LEVEL: Advanced. ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Rasch validation and comparison of the German versions of the Locomotor Capabilities Index-5 and Prosthetic Mobility Questionnaire 2.0 in lower-limb prosthesis users.

This study aimed to compare, through Rasch analysis, the psychometric properties of the Locomotor Capabilities Index (LCI-5) and Prosthetic Mobility Questionnaire (PMQ 2.0) in German lower-limb prosthesis users. The questionnaires were concurrently administered to a convenience sample of 98 consecutively recruited individuals with lower limb amputation (LLA) (male/female = 61/37; mean age 57 ± 14 years). LCI-5 showed disordered rating scale thresholds (one response option in three items required collapsing); local dependence between two items (resolved by creating a testlet); underfit of one item ('Get up from the floor'); and presence of a second weak dimension. PMQ 2.0 showed a correctly functioning rating scale; good fit of the data to the model (apart from some overfit); local dependence between two items (absorbed by creating a testlet); and essential unidimensionality. At scale co-calibration onto a common interval-scaled metric, PMQ 2.0 was better targeted than LCI-5 (i.e. the extent of item difficulty was more appropriate for the sample) and its operational range allowed a more precise measurement of higher locomotor abilities. The correlation between LCI-5 and PMQ 2.0 scores was rho = 0.78. In conclusion, LCI-5 revealed some drawbacks, confirming a previous Rasch study; refinement of its rating scale and item selection seems therefore warranted. The PMQ 2.0 demonstrated good overall measurement quality, in line with previous Italian and Slovene studies. The operational range of the PMQ 2.0 makes it more suitable than LCI-5 for assessing people with high locomotor abilities.

A Retrospective Analysis of the Initial Effect of COVID-19 on German Prehospital Care During Lockdown in Germany.

INTRODUCTION: This retrospective cohort analysis examines the impact of the COVID-19 pandemic in the prehospital setting in Germany. The data of two emergency physician response units of a northern German region with 1.2 million citizens was analyzed retrospectively. MATERIALS AND METHODS: We analyzed the period March 16 to April 16 for the year 2020 when the lockdown took place in Germany and compare the results for the same period for the year 2019 and 2018. 1004 patients were included. Demographic data, the type of rescue missions, the number of missions per day, the National Advisory Committee for Aeronautics Score (NACA-score), the frequency of respiratory emergencies (COVID-19 and non-COVID-19 associated), as well as the number of deaths were documented. RESULTS: Mean age was 62.3±24.8 years and 576 (56.5%) were male. Number of missions were 397, 403 and 333 in 2018, 2019 and 2020 respectively. The control room registered a 22% reduction of rescue missions for the year 2020. Even the amount of emergency calls via the emergency number 112 was reduced by 17.4% between 2018 and 2020. 150 (14.9%) missions were due to respiratory emergencies. In 2020 10 missions (28.6% of respiratory emergencies) were COVID-19 related. In 2020 the NACA score increased significantly. CONCLUSION: We found a decreasing effect of the COVID-19 pandemic in Germany on the number of emergency calls as well as missions, and an increase of the severity of cases in preclinical care for a northern German region with 1.2 million citizens. The effect of these findings caused by COVID-19 on the health care system remains to be seen.

Preoperative femoral abduction angle correlates with initial postoperative lateral hip pain after transcutaneous osseointegrated prosthetic system (TOPS) in transfemoral amputees.

PURPOSE: To analyse whether a preoperative femoral abduction angle (FAA) correlates with postoperative initial lateral hip pain (LHP) in above-knee amputees (AKA) treated with transcutaneous osseointegrated prosthetic system (TOPS). METHODS: Pre- and postoperative long-leg radiographs of eighteen unilateral AKA (mean age 51.55y ± 12.16) were retrospectively measured. FAA was measured on both sides. Pain intensity of LHP was measured by numeric rating scale (NRS) preoperatively and every week for four weeks from the first day of weight loading. Pearson's r was calculated for correlation. Furthermore, odds ratio for LHP ≥ 5/10 NRS and relative FAA > 13° was calculated. RESULTS: FAA significantly decreased in the postoperative period (pre/post. 15.33° ± 4.22; p < 0.001). Median LHP was 0/10 NRS (min.0, max.3) preoperatively and 4/10 NRS (min.2, max. 7, p < 0.001) postoperatively after first loading. Interestingly, it decreased within four weeks to a median of 0.5/10 NRS (min.0, max. 3) without intervention. A strong correlation was seen on the amputated side between preoperative FAA and LHP after loading (r = 0.835, p < 0.001), as well as the relative FAA to LHP after loading (r = 0.732, p < 0.001) and between the gap of pre- to postoperative FAA and LHP. Odds ratio for LHP ≥ 5/10 and relative FAA > 13° was 6.4 (95%CI = 0.55; 74.89). CONCLUSION: The preoperative FAA strongly correlates with postoperative LHP. Surgeons should be aware of high risk of LHP that can limit prosthetic training. High preoperative FAAs should be realised in the decision meeting of TOPS implantation and pre-rehabilitative reduction of the FAA should be taken into consideration.

[Transcutaneous osseointegrated prosthetic systems after major amputation of the lower extremity : A retrospective 3-year analysis]. / Transkutane osseointegrierte Prothesensysteme (TOPS) nach Majoramputation der unteren Extremität : Eine retrospektive 3-Jahres-Analyse.

INTRODUCTION: Transcutaneous osseointegrated prosthetic systems (TOPS) are an established optional procedure for the prosthetic treatment of amputations. Under the term endo-exo-prosthesis (EEP), the endosteal adapted exo-prosthesis (Dr. Grundei®) is currently used as the only standard prosthesis for clinical application in Germany. The prosthetic treatment with EEP involves a two-stage surgical procedure. In a first surgical step, the endo-fixed stem is implanted into the bone; in a second operation, approx. 2-6 weeks later, the skin/soft tissue stoma is created, through which the exoprosthetic components can be coupled transcutaneously. AIM: The aim of this manuscript was to retrospectively collect descriptive 3­year statistics (2017-2019) from clinical follow-ups and to analyze them with regard to possible effects of TOPS on the mobility level measured by k­levels. In addition, a brief description of the current standard of care in Germany regarding TOPS will be given. METHODS: All patients who underwent EEP after major amputation from February 2017 to December 2019 (n = 72, with 76 implants) were included in this study. The data of the EEP patients were collected in standardized follow-ups. K­levels were compared preoperatively to 6 months postoperatively. RESULTS: A total of N = 72 patients (N = 76 implantations) was analyzed in the described period. The main cause of amputations was trauma (68.9%). Main complications were myofascial complaints. Implant loosening and deep infections were observed in two cases (2.7%) during this period. Stoma problems occurred with a 3-year average of 25.7%. In terms of K­levels, there was a high significant increase from preoperative 1.8 ± 0.8 to 3.0 ± 0.4 after a 6-month period. CONCLUSION: TOPS is an established optional procedure for the treatment of limb loss. In Germany, only one implant is currently regularly implanted (endo-exo prosthesis), and the restoration is currently focused on the lower limb. The restoration of patients with major amputation of the lower extremity by means of TOPS can lead to an increase in mobility and, thus, to an increase in daily activities and participation in daily living.

[Transcutaneous Osseointegrated Prosthetic Systems (TOPS) for Transfemoral Amputees - A Six-Year Retrospective Analysis of the Latest Prosthetic Design in Germany]. / Transkutane osseointegrierte Prothesensysteme (TOPS) zur Versorgung Oberschenkelamputierter.

PURPOSE: A retrospective analysis of clinical outcomes and complication rates of patients treated with the latest implant design of the so-called Endo-Exo-Femoral Prosthesis (EEFP) was performed. The aim is to gain specific information on long-term complications of this treatment-method. METHODS: In January 2019, data of all transfemoral amputees who were treated with TOPS at an acute clinic in Schleswig-Holstein from 2010 to 2016 were retrospectively analysed. This was done with special consideration of postoperative complications. For this purpose, all examination findings from routine clinical follow-up examinations were used. The complications were divided into stoma problems, orthopaedic-technical (OT) problems, fractures and explantations. All EEFPs had the same implant design (3rd generation). This implant is currently the only TOPS in Germany that is clinically used. Descriptive statistics as well as ratio information about occurred complications were calculated. RESULTS: A total of 68 implantations were performed during this period. Average observation time was 6.32 years (±2.16 years). The mean age of the patients was 51.84 years±12.12 years. Cause of amputation was mainly trauma (82,35%). Stoma-associated problems had the highest incidence (7%) among all observed patient-related complications and posed the greatest challenges during the rehabilitation process. Looking only at surgical complications, 81% had no complications at all. In total, 15% had technical problems, 6% had peri-prosthetic fractures, 7% had stoma problems and 3% had to be explanted due to infection. CONCLUSION: The analysis of collected data shows that TOPS (here the 3rd generation EEFP) can be a successful alternative treatment method to shaft prostheses after transfemoral amputation. The indication should only be given after the failure of a shaft-prosthesis and contraindications must be comprehensively excluded. The greatest challenges in the rehabilitation process are the avoidance of stoma complications, infections and OT-problems. The rehabilitation of amputees treated with TOPS therefore requires an interdisciplinary, specialized rehabilitation team and lifelong rehabilitative care.