Transfemoral Amputation
Conditions
Keywords
Kenevo, MPK, specialized inpatient rehabilitation
Brief summary
Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. This study is conducted to evaluate the need to practice these guidelines in order to gain best benefits for the patients. Focus is set of early inpatient rehabilitation and the role of a microprocessor-controlled prothesis (Kenevo, Ottobock).
Detailed description
Right after major surgeries, e.g. amputations, inpatient rehabilitation follows in Germany. Costs are covered by different insurances, like public or private health care insurances or German pension insurance. Usually, inpatient rehabilitation lasts for 3 weeks. But after some surgeries, like amputation, patients need more time to recover and fitting of a prosthesis takes additional time. Therefore guidelines state, that rehabilitation should take up to 6-8 weeks after major amputation. To provide evidence to these guidelines, we conducted this study. Patients' choice on rehabilitation clinic decides on their assignment to the study group or control group. Inpatient rehabilitation is monitored with outcomes measurements. 3 measurements are carried out in the study group within rehabilitational stay of around 6 weeks (admission - middle - discharge) and 2 measurements are carried out in the control group within rehabilitational stay of around 3 weeks (admission - discharge). After discharge from rehabilitation, assessment of patient reported outcome measurements is continued every 6 weeks for both groups. Follow-up phase ends with 24 weeks after admission to rehabilitation. For subanalysis, different prosthetic devices (non-microprocessor-controlled vs. microprocessor-controlled prosthesis) are compared.
Interventions
OTHERAmputation-specialized rehabilitation
Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
OTHERNon-amputation-specialized rehabilitation
Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines
Sponsors
Otto Bock Healthcare Products GmbH
University Medical Center Mainz
Median
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Non-randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* inpatient rehabilitation stay after transfemoral amputation or knee disarticulation * anticipated K-level 1 or 2 * body weight no more than 125kg (authorized body weight for prosthetic device) * German speaking * able to give informed consent
Exclusion criteria
* non-German speaking * not able to give informed consent * body weight over 125kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Limb User's Survey of Mobility (PLUS-M) | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol questionnaire (EQ-5D-5L) | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Patient reported outcome measurement assessing quality of life, reported as health utility, score, score 0-1 with 0 meaning lowest quality of life and 1 highest quality of life |
| Falls | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Number of falls with prothesis |
| Fear of falling | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | indoor and outdoor fear of falling on a numeric rating scale (0-10) with 0 meaning no fear of falling and 10 meaning maximum fear of falling |
| Locomotor capability index (LCI 5) | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Patient reported outcome measurement assessing patients' locomotor capability, 14 questions, results are categorized in 2 dimension: basic or advanced activities, maximum score is 28 points for each dimension |
| Reintegration to normal living index (RNLI) | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Patient reported outcome measurement with 11 questions asking to patients' reintegration into daily life, reported as percentage |
| Timed Up and Go Test | At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay | Functional outcome measurement, assessing patients' capability to walk, time needed to get up from a chair, walk 3 m, turn and walk 3 m back until sitting down again |
| 6 minute walking test | At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay | Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded |
| AMP-PRO | At admission to rehabilitation facility (if patients are already equipped with a prosthesis), after 3 weeks and after 6 weeks (discharge from rehabilitation) of inpatient rehabilitation stay | Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points |
| Barthel Index | As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation) | Patient reported outcome measurement assessing patients' self care, 10 questions with maximum score of 100 points |
Countries
Germany
Contacts
Primary ContactJohannes Schröter, Dr. med.
Outcome results
None listed