An interventional study of knee prothesis - Avior and knee prothesis - Kenevo in Transfemoral Amputees, sponsored by Median. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Median · Not applicable, Interventional, and Supportive care
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:
Researchers will compare the Avior knee prothesis to the Kenevo knee prothesis to see if the preious results are achieved or surpassed.
Participants will:
Median is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: knee prothesis - Avior
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.
Device: knee prothesis - Kenevo
Usage of the Avior knee prothesis for 6 month during the interim period
Usage of Kenevo knee prothesis for the duration of 6 months during the interim period
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
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-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
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
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)
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
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)
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
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)
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
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)
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
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
Time frame: 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
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
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
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
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)
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
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)
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
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)
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Residual limb shape
The shape of the lower-limb residual limb is assessed and documented during clinical examination according to predefined clinical categories. Unit of Measure: Categorical assessment
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Prosthesis characteristics: study-specific prosthesis questionnaire
Characteristics of the participant's lower-limb prosthesis are documented using a study-specific prosthesis questionnaire. The questionnaire records predefined prosthesis characteristics and prosthetic components. Unit of Measure: type of prosthetic foot
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).
Changes in prosthesis: study-specific prosthesis questionnaire
Changes to the participant's lower-limb prosthesis and prosthetic components during the study are documented using a study-specific prosthesis questionnaire. Unit of Measure: number of prosthetic component changes
Time frame: 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 length
The length of the lower-limb residual limb is measured during clinical examination. Unit of Measure: Centimeters (cm)
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Residual limb circumference
The circumference of the lower-limb residual limb is measured during clinical examination. Unit of Measure: Centimeters (cm)
Time frame: Baseline (beginning of rehabilitation); 3 weeks after baseline; and 6 weeks after baseline (end of rehabilitation).
Plan to share: No
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