Randomized prospective evaluation of the clinical use of the Keep Walking Femoral Implant in European countries

Randomized prospective evaluation of the clinical use of the Keep Walking Femoral Implant in European countries - Randomized evaluation Keep Walking Femoral Implant

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46756

Enrollment

Registered

2018-12-06

Start date

2018-04-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Above-knee amputation Transfemoral amputation

Interventions

For in the intervention group the intervention consists of placing the Keep Walking Femoral Implant. There is no intervention for the control group.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Have been indicated for a transfemoral amputation due to traumatic, vascular, or oncologic aetiology; - In case of vascular aetiology: presence of femoral pulse with no significant stenosis (percentage of stenosis lower than 60%) and PPCI hemodynamic index below 0.25; - Have the ability to bear weight on the contralateral (intact) leg during at least 10 seconds, with or without using technical aids; - Have functional walking ability between 8-12 weeks prior to the amputation, with or without technical aids; - Have a residual femur length of at least 14 centimetre measured from the greater trochanter.

Exclusion criteria

Exclusion criteria: Absolute contraindications - Age

Design outcomes

Primary

Measure	Time frame
- Pain level as rated on a VAS scale - Distance/speed of walking assessed using the 6 Minutes Walking Test - Patient's quality of life assessed using the Prosthesis Evaluation Questionnaire and the SF-36 - Implant failure assessed using the number of Serious Adverse Events	—

Secondary

Measure	Time frame
- Bone mineral density assessed using bone densitometry - Hours of daily prosthetic use assessed using Houghton scale and a diary to keep track of prosthetic usage - Oxygen consumption during walking assessed using aerobic ergometry - Timed up and go test - Use of walking aids - Hip range of motion assessed using a goniometer - Number and type of skin and stump problems - Spatiotemporal, kinematic, and kinetic variables of walking assessed using an opto-electronic gait analysis system - Muscle activation patterns assessed using electromyography	—

Measure

Time frame

- Bone mineral density assessed using bone densitometry - Hours of daily prosthetic use assessed using Houghton scale and a diary to keep track of prosthetic usage - Oxygen consumption during walking assessed using aerobic ergometry - Timed up and go test - Use of walking aids - Hip range of motion assessed using a goniometer - Number and type of skin and stump problems - Spatiotemporal, kinematic, and kinetic variables of walking assessed using an opto-electronic gait analysis system - Muscle activation patterns assessed using electromyography

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)