Dataset Information

Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial.

ABSTRACT:

Background

Individuals with transfemoral amputations who are considered to be limited community ambulators are classified as Medicare functional classification (MFCL) level K2. These individuals are usually prescribed a non-microprocessor controlled knee (NMPK) with an appropriate foot for simple walking functions. However, existing research suggests that these individuals can benefit from using a microprocessor controlled knee (MPK) and appropriate foot for their ambulation, but cannot obtain one due to insurance policy restrictions. With a steady increase in older adults with amputations due to vascular conditions, it is critical to evaluate whether advanced prostheses can provide better safety and performance capabilities to maintain and improve quality of life in individuals who are predominantly designated MFCL level K2. To decipher this we conducted a 13 month longitudinal clinical trial to determine the benefits of using a C-Leg and 1M10 foot in individuals at K2 level with transfemoral amputation due to vascular disease. This longitudinal clinical trial incorporated recommendations prescribed by the lower limb prosthesis workgroup to design a study that can add evidence to improve reimbursement policy through clinical outcomes using an MPK in K2 level individuals with transfemoral amputation who were using an NMPK for everyday use.

Methods

Ten individuals (mean age: 63 ± 9 years) with unilateral transfemoral amputation due to vascular conditions designated as MFCL K2 participated in this longitudinal crossover randomized clinical trial. Baseline outcomes were collected with their current prosthesis. Participants were then randomized to one of two groups, either an intervention with the MPK with a standardized 1M10 foot or their predicate NMPK with a standardized 1M10 foot. On completion of the first intervention, participants crossed over to the next group to complete the study. Each intervention lasted for 6 months (3 months of acclimation and 3 months of take-home trial to monitor home use). At the end of each intervention, clinical outcomes and self-reported outcomes were collected to compare with their baseline performance. A generalized linear model ANOVA was used to compare the performance of each intervention with respect to their own baseline.

Results

Statistically significant and clinically meaningful improvements were observed in gait performance, safety, and participant-reported measures when using the MPK C-Leg + 1M10 foot. Most participants were able to achieve higher clinical scores in gait speed, balance, self-reported mobility, and fall safety, while using the MPK + 1M10 combination. The improvement in scores were within range of scores achieved by individuals with K3 functional level as reported in previous studies.

Conclusions

Individuals with transfemoral amputation from dysvascular conditions designated MFCL level K2 benefited from using an MPK + appropriate foot. The inference and evidence from this longitudinal clinical trial will add to the knowledgebase related to reimbursement policy-making. Trial registration This study is registered on clinical trials.gov with the study title "Functional outcomes in dysvascular transfemoral amputees" and the associated ClinicalTrials.gov Identifier: NCT01537211. The trial was retroactively registered on February 7, 2012 after the first participant was enrolled.

SUBMITTER: Jayaraman C

PROVIDER: S-EPMC8146219 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:The safe use of a prosthesis in activities of daily living is key for transfemoral amputees. However, the number of falls varies significantly between different prosthetic device types. This study aims to compare medical and economic consequences of falls in transfemoral amputees who use the microprocessor-controlled knee joint C-Leg with patients who use non-microprocessor-controlled (mechanical) knee joints (NMPK). The main objectives of the analysis are to investigate the cost-effectiveness and budget impact of C-Legs in transfemoral amputees with diabetes mellitus (DM) and without DM in Germany. METHODS:A decision-analytic model was developed that took into account the effects of prosthesis type on the risk of falling and fall-related medical events. Cost-effectiveness and budget impact analyses were performed separately for transfemoral amputees with and without DM. The study took the perspective of the statutory health insurance (SHI). Input parameters were derived from the published literature. Univariate and probabilistic sensitivity analyses (PSA) were performed to investigate the impact of changes in individual input parameter values on model outcomes and to explore parameter uncertainty. RESULTS:C-Legs reduced the rate of fall-related hospitalizations from 134 to 20 per 1000 person years (PY) in amputees without DM and from 146 to 23 per 1000 PY in amputees with DM. In addition, the C-Leg prevented 15 or 14 fall-related death per 1000 PY. Over a time horizon of 25 years, the incremental cost-effectiveness ratio (ICER) was 16,123 Euro per quality-adjusted life years gained (QALY) for amputees without DM and 20,332 Euro per QALY gained for amputees with DM. For the period of 2020-2024, the model predicted an increase in SHI expenditures of 98 Mio Euro (53 Mio Euro in prosthesis users without DM and 45 Mio Euro in prosthesis users with DM) when all new prosthesis users received C-Legs instead of NMPKs and 50% of NMPK user whose prosthesis wore out switched to C-Legs. Results of the PSA showed moderate uncertainty and a probability of 97-99% that C-Legs are cost-effective at an ICER threshold of 40,000 Euro (??German GDP per capita in 2018) per QALY gained. CONCLUSION:Results of the study suggest that the C-Leg provides substantial additional health benefits compared with NMPKs and is likely to be cost-effective in transfemoral amputees with DM as well as in amputees without DM at an ICER threshold of 40,000 Euro per QALY gained.

Project description:BackgroundAbove-knee amputation (AKA) is a rare but devastating complication of TKA. Although racial disparities have been previously reported in the utilization of TKA, it is unclear whether disparities exist in the rates of AKA after TKA.Questions/purposes(1) Which gender-racial group has the highest rate of AKA from septic and aseptic complications of TKA? (2) Which age groups have higher rates of AKA from septic and aseptic complications of TKA?MethodsUsing National Inpatient Sample data from 2000 to 2011, AKAs resulting from complications of TKA were identified using a combination of International Classification of Diseases, 9th Revision procedure and diagnosis codes. Of the 341,954 AKAs identified, 9733 AKAs were the result of complications of TKA (septic complications = 8104, aseptic complications = 1629). Standardized AKA rates were calculated for different age and gender- racial groups by dividing the number of AKAs in each group with the corresponding number of TKAs. Standardized rate ratios were calculated after adjusting for demographics and comorbidities.ResultsAfter adjusting for age and comorbidities, black men had the highest rate of AKA after TKA (adjusted rate in black men = 578 AKAs per 100,000 TKAs, standardized rate ratio [SRR] = 4.32 [confidence interval {CI}, 3.87-4.82], p < 0.001). Black men also had the highest rate of AKA after septic complications of TKA (p < 0.001). The adjusted rates of AKA were higher in patients younger than 50 years (adjusted rate = 473, SRR = 3.14 [CI, 2.94-3.36], p < 0.001) and older than 80 years (adjusted rate = 297, SRR = 1.85 [CI, 1.76-1.95], p < 0.001).ConclusionsThe rising demand for TKA has led to an increase in the number of AKAs performed for complications of TKA in the United States. Although we did not find an increase in the rate of AKA during the study period, certain populations, including black men and patients older than 80 years and younger than 50 years, had higher rates of AKA. Further studies are required to understand the reasons for these disparities and measures should be undertaken to eliminate these disparities.Level of evidenceLevel III, therapeutic study.