The Kenevo microprocessor-controlled prosthetic knee compared with non-microprocessor-controlled knees in individuals older than 65 years in Sweden: A cost-effectiveness and budget-impact analysis.

BACKGROUND: Growing evidence suggests that individuals with transfemoral amputation or knee disarticulation using a prosthesis equipped with a microprocessor-controlled knee (MPK) benefit from enhanced mobility and safety, including less falls. In elderly individuals, high mortality rates are assumed to reduce the expected useful life of MPKs, and this raises concerns regarding their economic effectiveness. OBJECTIVE: To investigate the cost-effectiveness and budget impact of the Kenevo/MPK (Ottobock, Germany) compared with non-microprocessor-controlled knees (NMPKs) in people older than 65 years at the time of transfemoral amputation/knee disarticulation, from a Swedish payer's perspective. METHODS: A decision-analytic model was developed to conduct the economic analysis of the Kenevo/MPK. Model parameters were derived from Swedish databases and published literature. Univariate and probabilistic sensitivity analyses were performed to explore parameter uncertainty. RESULTS: Compared with NMPKs, the Kenevo/MPK reduced the frequency of hospitalizations by 137 per 1,000 person years while the frequency of fatal falls was reduced by 19 per 1,000 person-years in the simulation. Over a 25-year time horizon, the incremental cost-effectiveness ratio was EUR11,369 per quality-adjusted life year. The probability of the MPK being cost-effective at a threshold of EUR40,000 per quality-adjusted life year was 99%. The 5-year budget impact model predicted an increase in payer expenditure of EUR1.76 million if all new patients received a Kenevo/MPK, and 50% of current NMPK users switched to the MPK. CONCLUSIONS: Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls.

SwedeAmp-the Swedish Amputation and Prosthetics Registry: 8-year data on 5762 patients with lower limb amputation show sex differences in amputation level and in patient-reported outcome.

Background and purpose - For want of national guidelines for lower limb amputation (LLA) the quality registry SwedeAmp was started in 2011 to increase knowledge around LLA and prosthetic rehabilitation. We now present data from the first 8 years of registration.Patients and methods - We present descriptive data from the first 8 years (2011-2018) of registration. Patient-reported outcome was collected at baseline and at follow-up 12 and 24 months after surgery for patients with prosthetic supply and included generic (EQ-5D-5L) and amputee-specific (e.g., LCI-5L and Prosthetic Use Score) measures. Sex differences were investigated.Results - As at December 31, 2018, 5,762 patients, 7,776 amputations, 2,658 prosthetic supplies, 1,848 baselines, and 2,006 follow-ups were registered. 61% of the patients were male, and mean age by the time of the first registered amputation was 74 years (SD 14). Women were older, more frequently had vascular disease without diabetes and more often underwent amputation at a higher level compared with men (p < 0.001). Time from amputation to fitting of first individual prosthesis was median 69 days (6-500) after transtibial amputation (TTA) and 97 days (19-484) after transfemoral amputation (TFA). The outcomes were lower after TFA than after TTA.Interpretation - SwedeAmp shows sex differences concerning amputation level, diagnosis, and age, leading to the conclusion that women have worse preconditions for successful prosthetic mobility after LLA. With increasing coverage, SwedeAmp can provide deeper knowledge with regard to patients undergoing LLA in Sweden.

Better implant survival with modern ankle prosthetic designs: 1,226 total ankle prostheses followed for up to 20 years in the Swedish Ankle Registry.

Background and purpose - We have previously reported on the prosthetic survival of total ankle replacements (TAR) in Sweden performed between 1993 and 2010. Few other reports have been published on 5- and 10-year survival rates. Furthermore, there is a lack of long-term outcome data on modern prosthetic designs. Therefore, we compared early and current prosthetic designs after a mean 7-year follow-up.Patients and methods - On December 31, 2016, 1,230 primary TARs had been reported to the Swedish Ankle Registry. We analyzed prosthetic survival, using exchange or permanent extraction of components as endpoint for 1,226 protheses with mean follow-up of 7 years (0-24). Differences between current (Hintegra, Mobility, CCI, Rebalance, and TM Ankle) and early prosthetic designs (STAR, BP, and AES) were examined by log rank test.Results - 267/1,226 prostheses (22%) had been revised by December 31, 2016. We found an overall prosthetic survival rate at 5 years of 0.85 (95% CI 0.83-0.87), at 10 years 0.74 (CI 0.70-0.77), at 15 years 0.63 (CI 0.58-0.67), and at 20 years 0.58 (CI 0.52-0.65). For early prosthetic designs the 5- and 10-year survival rates were 0.81 (CI 0.78-0.84) and 0.69 (CI 0.64-0.73) respectively, while the corresponding rates for current designs were 0.88 (CI 0.85-0.91) and 0.84 (CI 0.79-0.88). Current prosthetic designs had better survival (log rank test p < 0.001).Interpretation - Our results point to a positive time trend of prosthetic survival in Sweden; use of current prosthetic designs was associated with better prosthetic survival. Improved designs and instrumentation, more experienced surgeons, and improved patient selection may all have contributed to the better outcome.

Good outcome scores and high satisfaction rate after primary total ankle replacement.

Background and purpose - Total ankle replacement (TAR) is gaining popularity for treatment of end-stage ankle arthritis. Large patient-centered outcome studies are, however, few. Here, we report data from the Swedish Ankle Registry. Patients and methods - We examined outcomes after primary TAR in patients from the Swedish Ankle Registry using PROMs (Patient Reported Outcome Measures; generic: EQ-5D and SF-36, region specific: SEFAS (Self-Reported Foot and Ankle Score), and a question on satisfaction). We included 241 patients registered with primary TAR between 2008 and 2016 and who completed PROMs preoperatively and postoperatively up to 24 months. We evaluated changes in PROMs following surgery and estimated effects of age, diagnosis, prosthetic design, and preoperative functional score on the outcomes. Results - All absolute scores improved from preoperative to 24 months after surgery (p ≤ 0.001). 71% of the patients were satisfied or very satisfied at the latest follow-up and 12% dissatisfied or very dissatisfied. Postoperative SEFAS correlated with age (r = 0.2, p = 0.01) and preoperative SEFAS (r = 0.3, p < 0.001), as did patient satisfaction (r = -0.2; p ≤ 0.03). Postoperative SEFAS and EQ-5D were similar between different diagnoses or prosthetic designs. Preoperative SF-36 was associated with diagnosis (p ≤ 0.03), postoperative SF-36 with age (r = 0.2, p = 0.01) and diagnosis (p < 0.03). Interpretation - We found statistically and clinically significant improvements in patient-reported outcomes following TAR surgery. The postoperative region-specific SEFAS was positively associated with older age. Prosthetic design seemed not to influence patient-reported outcome, whereas diagnosis partly did. Studies with longer follow-up are necessary to establish the long-term outcome of TAR and to elucidate whether short- and mid-term outcomes may predict implant failure.

Bilateral Arthrodesis of the Ankle Joint: Self-Reported Outcomes in 35 Patients From the Swedish Ankle Registry.

Bilateral ankle arthrodesis is seldom performed, and results concerning the outcome and satisfaction can only sparsely be found in published studies. We analyzed the data from 35 patients who had undergone bilateral ankle arthrodesis in the Swedish Ankle Registry using patient-reported generic and region-specific outcome measures. Of 36 talocrural arthrodeses and 34 tibio-talar-calcaneal arthrodeses, 6 ankles (9%) had undergone repeat arthrodesis because of nonunion. After a mean follow-up period of 47 ± 5 (range 12 to 194) months, the mean scores were as follows: self-reported foot and ankle score, 33 ± 10 (range 4 to 48); the EuroQol Group's EQ-5D™ score, 0.67 ± 0.28 (range -0.11 to 1), the EuroQol Group's visual analog scale score, 70 ± 19 (range 20 to 95), 36-item Short Form Health Survey (SF-36) physical domain, 39 ± 11 (range 16 to 58); and SF-36 mental domain, 54 ± 14 (range 17 to 71). Patients with rheumatoid arthritis seemed to have similar self-reported foot and ankle scores but possibly lower EQ-5D™ and SF-36 scores. Those with talocrural arthrodeses scored higher than did those with tibio-talar-calcaneal arthrodeses on the EQ5D™ and SF-36 questionnaires (p = .03 and p = .04). In 64 of 70 ankles (91%), the patients were satisfied or very satisfied with the outcome. In conclusion, we consider bilateral ankle arthrodesis to be a reasonable treatment for symptomatic hindfoot arthritis, with high postoperative mid-term satisfaction and satisfactory scores on the patient-reported generic and region-specific outcome measures, when no other treatment option is available.

Outcome After Salvage Arthrodesis for Failed Total Ankle Replacement.

BACKGROUND: In cases with total ankle replacement (TAR) failure, a decision between revision TAR and salvage arthrodesis (SA) must be made. In a previous study, we analyzed revision TAR and found low functional outcome and satisfaction. The aims of the current study were to analyze SA concerning failure rate and patient-related outcome measures (PROMs). METHODS: Until September 2014, a total of 1110 primary TARs were recorded in the Swedish Ankle Registry. Of the 188 failures, 118 were revised with SA (and 70 with revision TAR). Patient- and implant-specific data for SA cases were analyzed as well as arthrodesis techniques. Failure of SA was defined as repeat arthrodesis or amputation. Generic and region-specific PROMs of 68 patients alive with a solid unilateral SA performed more than 1 year before were analyzed. RESULTS: The first-attempt solid arthrodesis rate of SA was 90%. Overall, 25 of 53 (47%) patients were very satisfied or satisfied. Mean Self-reported Foot and Ankle Score (SEFAS) was 22 (95% confidence interval 20-24), Euro Qol-5 Dimensions 0.57 (0.49-0.65), Euro Qol-Visual Analogue Scale 59 (53-64), Short Form-36 physical 34 (31-37) and mental 50 (46-54). The scores and satisfaction were similar to those after revision TAR but the reoperation rate was significantly lower in SA (P < .05). CONCLUSION: Salvage arthrodesis after failed TAR had a solid arthrodesis rate of 90% at first attempt, but similar to revision TAR, less than 50% of the patients were satisfied and the functional scores were low. Until studies show true benefit of revision TAR over SA, we favor SA for failed TAR. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Poor prosthesis survival and function after component exchange of total ankle prostheses.

BACKGROUND AND PURPOSE: In failed total ankle replacements (TARs), fusion is often the procedure of preference; the outcome after exchanging prosthetic components is debated. We analyzed prosthetic survival, self-reported function, and patient satisfaction after component exchange. Patients and methods We identified patients in the Swedish Ankle Registry who underwent exchange of a tibial and/or talar component between January 1, 1993 and July 1, 2013 and estimated prosthetic survival by Kaplan-Meier analysis. We evaluated the patient-reported outcome measures (PROMs) SEFAS, EQ-5D, EQ-VAS, SF-36, and patient satisfaction by direct questions. RESULTS: 69 patients underwent revision TAR median 22 (0-110) months after the primary procedure. 24 of these failed again after median 26 (1-110) months. Survival analysis of revision TAR showed a 5-year survival rate of 76% and a 10-year survival of 55%. 29 patients with first revision TAR in situ answered the PROMs at mean 8 (1-17) years after revision and had the following mean scores: SEFAS 22, SF-36 physical 37 and mental 49, EQ-5D index 0.6, and EQ-VAS 64. 15 of the patients were satisfied, 5 were neither satisfied nor dissatisfied, and 9 were dissatisfied. INTERPRETATION: Revision TAR had a 10-year survival of 55%, which is lower than the 10-year survival of 74% for primary TAR reported from the same registry. Only half of the patients were satisfied. Future studies should show which, if any, patients benefit from revision TAR and which patients should rather be fused directly.