The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- 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
Background summary
After a conventional transfemoral amputation, the residual leg cannot be
distally loaded as this will create an pressure ulcer due to a high load of the
residual femur on the soft tissue of the stump. This means that the exerted
load on the leg during walking needs to be transferred to other body parts.
Usually this load is transferred to the ischial bones through the stump socket.
This, however, has some disadvantages. Transferring the load to the ischial
bones requires a long stump socket which can be uncomfortable during sitting
down. In addition, it can pinch the skin during walking which can be highly
uncomfortable. The Spanish company Tequir, developed a possible solution for
these problems. They developped the Keep Walking Femoral Implant. Placing this
implant creates a stump that can be partially distally loaded, which decreases
the need to transfer loading forces to other body parts. A clinical study that
was performed as part of the CE-marking process showed that placing the Keep
Walking Femoral Implant increased walking function and decreased pain level.
The next step is to investigate whether these results hold up in a larger
European study.
Study objective
The primary objective is to obtain post-market clinical data according to the
requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market
surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section
3 of Annex IV, Section 3 of Annex V, Section 3.1 of Annex VI or Section 4 20 of
Annex VII of the Medical Devices Directive (94/42/EEC).
Study design
The study is designed as an international multicenter randomized clinical
study.
Intervention
For in the intervention group the intervention consists of placing the Keep
Walking Femoral Implant.
There is no intervention for the control group.
Study burden and risks
The burden and risk associated with participation are mainly limited to the
risk that is associated with the placement of the Keep Walking Femoral Implant.
In the initial study, complications led to the extraction of the Keep Walking
Femoral Implant in 6 of the 29 subjects. By applying stricter inclusion
criteria, it is thought that this risk is descreased in the current study.
The tests that we will apply in this research are comparable to activities of
daily living and we therefore believe that this burden is relatively low. There
is no added risk associated with the measurements.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
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
Absolute contraindications
- Age <18 years
- Active neoplasia pathology
- Currently undergoing chemotherapy treatment
- Currently using immunosuppressant
- Sepsis or active infection
- Residual length of the femur less than 12 cm measured from the greater trochanter
- Pregnancy
- Alcohol or drug addiction
- Alterations of the central nervous system (CNS): dementia, cerebral tumours, degenerative pathology etc.
- Patient that does not consent to participation in the study
- Psychiatric disorders
- Allergy to any of the components of the implant;Relative contraindications
- Severe osteopenia or osteoporosis (cortical bone thickness less than 3 mm)
- Previous infection of the stump
- Deformity in hip flexion greater than 300
- Residual length of the femur between 12 and 14 cm measured from the greater trochanter.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65121.044.18 |
| Other | Nog niet bekend |