CLINICAL TRIAL

Kenevo or C-Leg 4 for Lower Limb Amputation Knee

EnrollingByInvitation · 65+ · All Sexes · Stroudsburg, PA

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.

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About the trial for Lower Limb Amputation Knee

Eligible Conditions
Lower Limb Amputation Knee · Lower Limb Amputation Above Knee (Injury) · Congenital Amputation of Lower Limb

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Kenevo or C-Leg 4
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Non microprocessor controlled knee (NMPK)
DEVICE

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Unilateral transfemoral or knee disarticulation amputation
An individual who received a prosthesis between 4 and 24 months prior to the study and currently uses a prosthesis was included in the study. show original
The patient is in stable condition with K2 ambulator status show original
This person is bilingual and can speak English or Spanish. show original
The study participants must be at least 65 years old at the time of the baseline assessment. show original
required You need a Minimum Socket Comfort Score (SCS) of 6/10 to be comfortable. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

12-month fall count from bi-weekly fall journal
12 MONTHS
On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.
12 MONTHS
Average daily step counts
12 MONTHS
Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.
12 MONTHS
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29
3 YEARS
Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.
3 YEARS
10-meter Walk Test (10mWT)
3 YEARS
The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.
3 YEARS
Timed Up and Go (TUG)
3 YEARS
The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.
3 YEARS
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
3 YEARS
This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.
3 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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