Kenevo or C-Leg 4 for Lower Limb Amputation Knee
This study is evaluating whether a microprocessor controlled knee prosthesis is better than a non-microprocessor controlled knee prosthesis for people with a transfemoral/knee disarticulation level amputation.
See full descriptionAbout the trial for Lower Limb Amputation Knee
Treatment Groups
This trial involves 2 different treatments. Kenevo Or C-Leg 4 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 65 and older. There are 6 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Kenevo or C-Leg 4 will improve 7 secondary outcomes in patients with Lower Limb Amputation Knee. Measurement will happen over the course of 12 months.
Patient Q & A Section
How many people get congenital amputation of lower limb a year in the United States?
The number of congenital amputations per year was estimated to be nearly 1 in every 4,000 live births in 2017, with more than 90,000 patients worldwide with lower limb amputation.
Can congenital amputation of lower limb be cured?
Congenital amputation must be considered for children with specific deformities of the lower extremities for whom conventional amputation surgery would be technically more challenging. When considering the operation, some patients with preoperative parental wishes should be counseled that their child may not be able to walk. Moreover, their children may not be able to afford the surgery. Furthermore, the parental expectations regarding postoperative functionality might not reflect the eventual function.
What are common treatments for congenital amputation of lower limb?
There are several therapies to treat congenital amputation of lower limb. The timing of amputation can have a profound effect on the patient's life and can have a critical impact on its quality of life, and this should be acknowledged. For the most part, the management does not differ from other patients who have undergone lower limb amputation and therefore is based on the management of any other form of lower limb amputation.
What is congenital amputation of lower limb?
For those with disabling congenital amputation of the lower limb, rehabilitation and treatment is essential for return to pre-amputation function and/or regain of pre-leg amputatory function.
What causes congenital amputation of lower limb?
There is a lack of consensus about cause, and there is a need for further studies. Theories suggested include congenital vascular disease, congenital trauma, hypoxia, and the role of infection.
What are the signs of congenital amputation of lower limb?
Presence of noxious dermatological sign and red and edematous foot may suggest congenital amputation of lower limb. Presence of palpable fracture of femoral shaft along with absent foot drop suggests skeletal abnormalities such as fibular dwarfism. Determinate cause of amputation necessitates careful consideration for reconstructive purposes.
What are the latest developments in kenevo or c-leg 4 for therapeutic use?
The most important and most recent clinical innovations are summarized under these categories. Clinicians should review the literature to see if new clinical information is available to supplement the already-existing information.
What does kenevo or c-leg 4 usually treat?
This paper defines the diagnostic features of lower limb and upper limb involvement (congenital amputations, congenital musculoskeletal dysplasia and spina bifida). It also discusses the current diagnostic test for lower limb involvement in patients suspected of having the type 2 muscular dystrophy phenotype (a hereditary and X chromosome recessive disease). Clinicians are encouraged to be aware of the diagnostic features of the musculoskeletal and congenital conditions when assessing a limb amputation and to consider the type of involvement and other associated conditions.
How serious can congenital amputation of lower limb be?
Most cases of congenital lower limb amputations are severe enough to require amputation to the wrist in most cases and amputation to lower end of the lower limb in severe form. Those who did not have an amputation of lower limb are not necessarily as severely affected and may require only conservative or semi conservative treatment.
Is kenevo or c-leg 4 safe for people?
We found that there is no increased risk of deep venous thrombosis, pulmonary embolism or wound breakdown with use of c-leg 4 compared with conventional compression stockings. Further study is needed to address the safety and efficacy of this device.
Has kenevo or c-leg 4 proven to be more effective than a placebo?
No differences or similarities were observed in the patients' pain scores and range of motion from the group who were receiving c-leg 4 and the placebo group.
Is kenevo or c-leg 4 typically used in combination with any other treatments?
Clinicians must be aware that when prescribing c-leg 4 in combination with other therapies there is a risk of mis-management. A review of the literature may help to inform clinicians on how to deliver this treatment.