Transfemoral AmputeesNCT07898098
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
A study testing knee prothesis - Avior and knee prothesis - Kenevo in people with Transfemoral Amputees, run by Median at 1 site in Germany.
Trial summary
The goal of this clinical trial is to compare microprocessor-controlled knee prostheses in early rehabilitation in amputees with transfemoral amputations and low mobility (K I-II). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfemoral Amputees
- What is being tested?
- knee prothesis - Avior and knee prothesis - Kenevo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jul 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with a primary diagnosis of: transfemoral amputation or knee disarticulation
- Expected level of mobility I or II
- Body weight up to 125 kg (maximum body weight for the Avior prosthetic knee joint)
- Patients who are capable of independently consenting to participate in the study and following the study protocol
Who cannot join
- Participants who are unable to give consent
- Insufficient knowledge of German to understand the questions in the assessed scores and to follow the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
MEDIAN Reha-Zentrum Wiesbaden Sonnenberg
Wiesbaden, Hesse, 65191
About this study
Official title: "Comparison of Microprocessor-controlled Knee Prostheses in Early Rehabilitation Following Transfemoral Amputation and Low Mobility (I-II) - a Non-inferiority Study"
The goal of this clinical trial is to compare microprocessor-controlled knee prostheses in early rehabilitation in amputees with transfemoral amputations and low mobility (K I-II). The main question it aims to answer is:
- Does the Avior knee prosthesis in early rehabilitation improve the mobility and well-being of the patients?
- Is the Avior knee prothesis suitable for use in early rehabilitation?
- Is the Avior knee prothesis suitable for use of amputees with low mobility (K I-II?
Read more
Researchers will compare the Avior knee prothesis to the Kenevo knee prothesis to see if the preious results are achieved or surpassed.
Participants will:
- wear the knee protheses to be tested for 6 months
- complete mobility tests during their 6 weeks stay at the rehabilitation facility (every 3 weeks --> total: 3 times)
- fill out questionairs concerning their mobilty and pain perception
- Conditions
- Transfemoral Amputees
- Being tested
- knee prothesis - Avior, knee prothesis - Kenevo
- Keywords
- microprocessor-controlled knee protheses, early rehabilitation, low mobility (K I-II)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee prothesis - AviorDevice
Usage of the Avior knee prothesis for 6 month during the interim period
knee prothesis - KenevoDevice
Usage of Kenevo knee prothesis for the duration of 6 months during the interim period
| Study group | Role | What they receive |
|---|---|---|
| Avior Knee | Experimental | This group recieves the Avior-joint as a knee prosthesis and not the Kenevo-joint as the other group. Otherwise all interventions are the same as in the other group. Receives: Device: knee prothesis - Avior |
| Kenevo-Knee | Experimental | This group recieves the Kenevo-joint as a knee prosthesis and not the Avior-joint as the other group. Otherwise all interventions are the same as in the other group. The data of this group is already available and published. Receives: Device: knee prothesis - Kenevo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of lower-limb prosthesis users: PLUS-M™ 12-Item Short Form T-score
Mobility of lower-limb prosthesis users is assessed using the Prosthetic Limb Users Survey of Mobility (PLUS-M™) 12-Item Short Form (v1.2). The questionnaire consists of 12 items assessing the participant's ability to perform various mobility-related activities. Each item is rated on a 5-level response scale. The responses are scored according to the PLUS-M™ scoring procedure to obtain a standardized PLUS-M™ T-score. The raw score is used only to determine the corresponding T-score. Higher T-scores indicate greater mobility.
Unit of Measure:
PLUS-M™ T-score
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Secondary outcomes (15)
Health-related quality of life: EQ-5D-5L index score
Health-related quality of life is assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The questionnaire assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems or unable to perform the activity, as applicable). The responses across the five dimensions are converted into a single EQ-5D-5L index score using the German EQ-5D-5L value set (Ludwig et al., 2018).
Unit of Measure:
EQ-5D-5L index score
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Health-related quality of life: EQ Visual Analogue Scale (EQ VAS) score
Self-rated health status is assessed using the EQ Visual Analogue Scale (EQ VAS) of the EQ-5D-5L questionnaire. Participants rate their current health status on a visual analogue scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Unit of Measure:
EQ VAS score (0-100)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Reintegration into normal living: Reintegration to Normal Living Index (RNLI) total score
Reintegration into normal living is assessed using the 11-item Reintegration to Normal Living Index (RNLI). The questionnaire assesses the participant's perceived ability to participate in and manage activities, roles, and relationships in daily life. Each item is rated on a 10-point scale ranging from 0 (does not describe my situation at all) to 10 (describes my situation perfectly). The scores of the 11 items are summed to obtain a total RNLI score ranging from 0 to 110 points. Higher scores indicate greater reintegration into normal living.
Unit of Measure:
RNLI total score (0-110 points)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Locomotor capabilities: Locomotor Capabilities Index-5 (LCI-5) total score
Locomotor capabilities with a lower-limb prosthesis are assessed using the Locomotor Capabilities Index-5 (LCI-5). The questionnaire consists of 14 items assessing the participant's ability to perform basic and advanced locomotor activities while using a prosthesis. Each item is scored from 0 (not able to perform the activity) to 4 (able to perform the activity independently without walking aids). Item scores are summed to obtain the total LCI-5 score. Higher scores indicate greater locomotor capability.
Unit of Measure:
LCI-5 total score (0-56 points)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Independence in activities of daily living: Barthel Index total score
Independence in activities of daily living is assessed using the Barthel Index. The assessment covers 10 activities of daily living. Individual activities are scored according to the Barthel Index scoring procedure and combined to obtain a total Barthel Index score. Higher scores indicate greater independence in activities of daily living.
Unit of Measure:
Barthel Index total score (0-100 points)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Functional mobility: Timed Up and Go (TUG) test completion time
Functional mobility is assessed using the Timed Up and Go (TUG) test. The participant starts in a seated position, stands up, walks 3 meters, turns around, walks back, and sits down. The time required to complete the test is measured from initiation of the movement until the participant returns to the seated position.
Unit of Measure:
Seconds
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Falls: number of falls
The occurrence of falls is assessed using a study-specific fall survey. The number of falls experienced by the participant during the specified assessment period is recorded.
Unit of Measure:
Number of falls
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Fear of falling: Numerical Rating Scale (NRS) score
Fear of falling is assessed using a numerical rating scale (NRS) included in the study-specific fall survey. The participant rates their fear of falling on the NRS.
Unit of Measure:
NRS score
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Residual limb wound healing: Pressure Ulcer Scale for Healing (PUSH) total score
Residual limb wound healing is assessed using the Pressure Ulcer Scale for Healing (PUSH). The PUSH assesses three wound characteristics: wound surface area, wound exudate, and wound tissue type. Wound surface area is determined by measuring the maximum wound length and width and calculating length × width. The resulting wound area is categorized and scored from 0 to 10 points. Wound exudate is categorized as none, scant, moderate, or heavy and scored from 0 to 3 points. Wound tissue type is categorized and scored from 0 to 4 points. The three component scores are summed to obtain a total PUSH score ranging from 0 to 17 points.
Unit of Measure:
PUSH total score (0-17 points)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Functional mobility: Amputee Mobility Predictor with Prosthesis (AMPPRO) total score
Functional mobility of lower-limb prosthesis users is assessed using the Amputee Mobility Predictor with Prosthesis (AMPPRO). The AMPPRO is a 21-item performance-based assessment evaluating sitting and standing balance, transfers, gait initiation, gait pattern, turning, variable cadence, obstacle negotiation, stair negotiation, and use of walking aids. Individual item scores are combined according to the AMPPRO scoring procedure to obtain a total AMPPRO score ranging from 0 to 47 points. Higher scores indicate better functional mobility.
Unit of Measure:
AMPPRO total score (0-47 points)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Walking capacity: 2-Minute Walk Test distance
Walking capacity is assessed using the 2-Minute Walk Test (2MWT). The distance walked by the participant during 2 minutes is measured.
Unit of Measure:
Meters (m)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Walking capacity: 6-Minute Walk Test distance
Walking capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked by the participant during 6 minutes is measured.
Unit of Measure:
Meters (m)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Phantom limb pain intensity
Phantom limb pain intensity is assessed during clinical examination using a numerical rating scale (NRS). The participant rates the intensity of phantom limb pain.
Unit of Measure:
NRS score (0-10)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Residual limb pain intensity
Residual limb pain intensity is assessed during clinical examination using a numerical rating scale (NRS). The participant rates the intensity of pain experienced in the residual limb.
Unit of Measure:
NRS score (0-10)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Other pain intensity
Pain other than phantom limb pain or residual limb pain is assessed during clinical examination using a numerical rating scale (NRS). The location and description of the pain are documented, and the participant rates its intensity.
Unit of Measure:
NRS score (0-10)
Measured: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start7 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Transfemoral AmputeesStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It's a non-inferior study and the current recruitment is for the same intervention, which will be compared to already existing and published data from a previous group with different intervention.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Median
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schroeter, Median
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898098
- Sponsor's protocol ID
- Avior2026
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raisig N, Schröter J, Hahn A, Traub F. Presented at: AOPA National Assembly; 2025 Sep 5; Orlando, USA. "Clinical experience with using MPKs as the first prosthetic knee in patients after transfemoral amputation in Germany"
Schröter J, Raisig N, Hahn A, Traub F. Presented at: ISPO World Congress; 2025 Jun 16; Stockholm, Sweden. "Specialized rehabilitation including early MPK mobilization: Impact of quality of life of limited community ambulators after transfemoral amputation"
Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228.
PubMed 28273329Deutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie e.V. (DGOOC) (Hrsg.). Sk2-Leitlinie "Rehabilitation nach Majoramputation an der unteren Extremität (proximal des Fußes)" (AMWFLeitlinienregister Nr. 033-044). Stand 24.06.2019 2019. Accessed 30/10/2025. https://www.awmf.org/uploads/tx_szleitlinien/033-044l_S2k_Rehabilitation_Majoramputation-untere_Extremitaet_2019-09.pdf
Chow, S.-C., Shao, J., Wang, H., & Lokhnygina, Y. (2017). Sample Size Calculations in Clinical Research (3rd ed.). Chapman and Hall/CRC. https://doi.org/10.1201/9781315183084
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Microprocessor-controlled Knee Prostheses in Early Rehabilitation Following Transfemoral Amputation and Low Mobility (I-II) - a Non-inferiority Study"
- ClinicalTrials.gov ID
- NCT07898098
- Acronym / sponsor ID
- Avior2026
- Conditions
- Transfemoral Amputees
- Keywords
- microprocessor-controlled knee protheses, early rehabilitation, low mobility (K I-II)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- MedianUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
The goal of this clinical trial is to compare microprocessor-controlled knee prostheses in early rehabilitation in amputees with transfemoral amputations and low mobility (K I-II). The main question it aims to answer is:
- Does the Avior knee prosthesis in early rehabilitation improve the mobility and well-being of the patients?
- Is the Avior knee prothesis suitable for use in early rehabilitation?
- Is the Avior knee prothesis suitable for use of amputees with low mobility (K I-II?
Researchers will compare the Avior knee prothesis to the Kenevo knee prothesis to see if the preious results are achieved or surpassed.
Participants will:
- wear the knee protheses to be tested for 6 months
- complete mobility tests during their 6 weeks stay at the rehabilitation facility (every 3 weeks --> total: 3 times)
- fill out questionairs concerning their mobilty and pain perception
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It's a non-inferior study and the current recruitment is for the same intervention, which will be compared to already existing and published data from a previous group with different intervention.
| Arm | Type | Receives |
|---|---|---|
| Avior Knee | Experimental | Device: knee prothesis - AviorThis group recieves the Avior-joint as a knee prosthesis and not the Kenevo-joint as the other group. Otherwise all interventions are the same as in the other group. |
| Kenevo-Knee | Experimental | Device: knee prothesis - KenevoThis group recieves the Kenevo-joint as a knee prosthesis and not the Avior-joint as the other group. Otherwise all interventions are the same as in the other group. The data of this group is already available and published. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient rehabilitation with a primary diagnosis of: transfemoral amputation or knee disarticulation
- Expected level of mobility I or II
- Body weight up to 125 kg (maximum body weight for the Avior prosthetic knee joint)
- Patients who are capable of independently consenting to participate in the study and following the study protocol
Key exclusion criteria (2 listed)
- Participants who are unable to give consent
- Insufficient knowledge of German to understand the questions in the assessed scores and to follow the study protocol
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 |
|---|---|---|
| knee prothesis - AviorUsage of the Avior knee prothesis for 6 month during the interim period | Device | Avior Knee |
| knee prothesis - KenevoUsage of Kenevo knee prothesis for the duration of 6 months during the interim period | Device | Kenevo-Knee |
Primary outcome
Mobility of lower-limb prosthesis users: PLUS-M™ 12-Item Short Form T-score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Mobility of lower-limb prosthesis users is assessed using the Prosthetic Limb Users Survey of Mobility (PLUS-M™) 12-Item Short Form (v1.2). The questionnaire consists of 12 items assessing the participant's ability to perform various mobility-related activities. Each item is rated on a 5-level response scale. The responses are scored according to the PLUS-M™ scoring procedure to obtain a standardized PLUS-M™ T-score. The raw score is used only to determine the corresponding T-score. Higher T-scores indicate greater mobility. Unit of Measure: PLUS-M™ T-score
15 secondary outcomes
Health-related quality of life: EQ-5D-5L index score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Health-related quality of life: EQ Visual Analogue Scale (EQ VAS) score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Reintegration into normal living: Reintegration to Normal Living Index (RNLI) total score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Locomotor capabilities: Locomotor Capabilities Index-5 (LCI-5) total score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Independence in activities of daily living: Barthel Index total score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Functional mobility: Timed Up and Go (TUG) test completion time
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Falls: number of falls
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Fear of falling: Numerical Rating Scale (NRS) score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).
Residual limb wound healing: Pressure Ulcer Scale for Healing (PUSH) total score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Functional mobility: Amputee Mobility Predictor with Prosthesis (AMPPRO) total score
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Walking capacity: 2-Minute Walk Test distance
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Walking capacity: 6-Minute Walk Test distance
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Phantom limb pain intensity
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Residual limb pain intensity
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Other pain intensity
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BackgroundRaisig N, Schröter J, Hahn A, Traub F. Presented at: AOPA National Assembly; 2025 Sep 5; Orlando, USA. "Clinical experience with using MPKs as the first prosthetic knee in patients after transfemoral amputation in Germany"
- BackgroundSchröter J, Raisig N, Hahn A, Traub F. Presented at: ISPO World Congress; 2025 Jun 16; Stockholm, Sweden. "Specialized rehabilitation including early MPK mobilization: Impact of quality of life of limited community ambulators after transfemoral amputation"
- Background: PubMed 28273329Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228.
- BackgroundDeutsche Gesellschaft für Orthopädie und Orthopädische Chirurgie e.V. (DGOOC) (Hrsg.). Sk2-Leitlinie "Rehabilitation nach Majoramputation an der unteren Extremität (proximal des Fußes)" (AMWFLeitlinienregister Nr. 033-044). Stand 24.06.2019 2019. Accessed 30/10/2025. https://www.awmf.org/uploads/tx_szleitlinien/033-044l_S2k_Rehabilitation_Majoramputation-untere_Extremitaet_2019-09.pdf
- BackgroundChow, S.-C., Shao, J., Wang, H., & Lokhnygina, Y. (2017). Sample Size Calculations in Clinical Research (3rd ed.). Chapman and Hall/CRC. https://doi.org/10.1201/9781315183084
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee prothesis - Avior and knee prothesis - Kenevo in people with Transfemoral Amputees, 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility of lower-limb prosthesis users: PLUS-M™ 12-Item Short Form T-score (time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; 6 weeks after baseline (end of rehabilitation); 12 weeks after baseline (first follow-up); 18 weeks after baseline (second follow-up); and 24 weeks after baseline (last follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898098, which also lists 5 linked publications.
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 27 Oct 2026.