Transfemoral AmputationNCT06045468
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients
A study testing Amputation-specialized rehabilitation and Non-amputation-specialized rehabilitation in people with Transfemoral Amputation, run by Median at 1 site in Germany.
Trial summary
Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- Amputation-specialized rehabilitation and Non-amputation-specialized rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-German speaking
- not able to give informed consent
- body weight over 125kg
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
MEDIAN Clinics
Wiesbaden
Johannes Schroeter, Dr. med., 0049 611 575811, johannes.schroeter@median-kliniken.de
About this study
Official title: Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
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).
Read the 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.
- Conditions
- Transfemoral Amputation
- Being tested
- Amputation-specialized rehabilitation, Non-amputation-specialized rehabilitation
- Keywords
- Kenevo, MPK, specialized inpatient rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amputation-specialized rehabilitationOther
Study center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines
Non-amputation-specialized rehabilitationOther
Control clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients in inpatient rehabilitation in study center. Receives: Other: Amputation-specialized rehabilitation |
| Control group | Experimental | Patients in inpatient rehabilitation facility of collaborating clinics. Receives: Other: Non-amputation-specialized rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Limb User's Survey of Mobility (PLUS-M)
Patient reported outcome measurement with 12 questions assessing mobility; reported as t-score, max. t-score: 65.7
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Secondary outcomes (9)
Reintegration to normal living index (RNLI)
Patient reported outcome measurement with 11 questions asking to patients' reintegration into daily life, reported as percentage
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
EuroQol questionnaire (EQ-5D-5L)
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
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Falls
Number of falls with prothesis
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Fear of falling
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
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Locomotor capability index (LCI 5)
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
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Barthel Index
Patient reported outcome measurement assessing patients' self care, 10 questions with maximum score of 100 points
Measured: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Timed Up and Go Test
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
Measured: 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
6 minute walking test
Patient walks back and forth 12 m for 6 minutes, distance in meter is recorded
Measured: 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
AMP-PRO
Functional outcome measurement, amputated-specific, assesses different activities of daily life, max. score 43 points
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Median
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH, University Medical Center Mainz
- Responsible party
- Principal investigator, Johannes Schroeter, Median
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045468
- Sponsor's protocol ID
- Kenevo2023
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
- ClinicalTrials.gov ID
- NCT06045468
- Acronym / sponsor ID
- Kenevo2023
- Conditions
- Transfemoral Amputation
- Keywords
- Kenevo, MPK, specialized inpatient rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- MedianUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH, University Medical Center Mainz
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Amputation-specialized rehabilitationPatients in inpatient rehabilitation in study center. |
| Control group | Experimental | Other: Non-amputation-specialized rehabilitationPatients in inpatient rehabilitation facility of collaborating clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- non-German speaking
- not able to give informed consent
- body weight over 125kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amputation-specialized rehabilitationStudy center; amputation-specialized unit within rehabilitation facility; fully practicing national guidelines | Other | Study group |
| Non-amputation-specialized rehabilitationControl clinics; treating some amputated patients each year but do not practice national guidelines or partially practicing national guidelines | Other | Control group |
Primary outcome
Prosthetic Limb User's Survey of Mobility (PLUS-M)
Time frame: 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
9 secondary outcomes
Reintegration to normal living index (RNLI)
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
EuroQol questionnaire (EQ-5D-5L)
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Falls
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Fear of falling
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Locomotor capability index (LCI 5)
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Barthel Index
Time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)
Timed Up and Go Test
Time frame: 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
6 minute walking test
Time frame: 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
AMP-PRO
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amputation-specialized rehabilitation and Non-amputation-specialized rehabilitation in people with Transfemoral Amputation, run by Median at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Schröter, Dr. med. (0049611757811, johannes.schroeter@median-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Limb User's Survey of Mobility (PLUS-M) (time frame: As follow-up 24 weeks after admission to rehabilitation (around 18-21 weeks after discharge from rehabilitation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.