Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-06 @ 7:04 AM
Study NCT ID:
NCT02765035
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Milana.Mileusnic@Ottobock.com', 'phone': '+4315233786733', 'title': 'Director of Clinical Research and Services Vienna', 'organization': 'Otto Bock Healthcare GmbH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'From 11 subjects that participated in the study, only 7 followed protocol. From post-hoc power analysis, 22 subjects would be required for 80% power to detect a difference of 35.9m (standard deviation = 30.3m) in the 6MWT.\n\nPatients were aware that a walking speed of greater than 0.8 m/s was a prerequisite for study participation, which could have lead to bias (elevated baseline measurement) and explain the small change in observed walking speed with C-Leg 3 and C-Leg 4 compared to baseline.'}}, 'adverseEventsModule': {'timeFrame': '36-40 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Residual limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in 6 Minute Gait Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '380.4', 'spread': '69.66', 'groupId': 'OG000'}, {'value': '380.4', 'spread': '69.66', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline after accommodation', 'categories': [{'measurements': [{'value': '35.9', 'spread': '20.26', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '33.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'groupDescription': 'C-Leg 3 vs. NMPK (Baseline)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.04', 'groupIds': ['OG001'], 'groupDescription': 'C-Leg 4 vs. NMPK (Baseline)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'A measure of walking endurance, the distance walked in meters after 6 minutes.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 10 Meter Gait Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'SSWS at Baseline', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.168', 'groupId': 'OG001'}]}]}, {'title': 'SSWS after acclimation', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'FWS at Baseline', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.262', 'groupId': 'OG001'}]}]}, {'title': 'FWS after acclimation', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Stairs Assessment Index (SAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline SAI (Ascent)', 'categories': [{'measurements': [{'value': '5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Change in SAI (Ascent) after fitting and acclimation', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline SAI (Descent)', 'categories': [{'measurements': [{'value': '4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '4', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Change in SAI (Descent) after fitting and acclimation', 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline time to descent stairs', 'categories': [{'measurements': [{'value': '12.7', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 'Change in time to descent stairs after fitting and acclimation', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hill Assessment Index (HAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline HAI (Ascent)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Change in HAI (Ascent) after fitting and acclimation', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline HAI (Descent)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Change in HAI (Descent) after fitting and acclimation', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Descent Time', 'categories': [{'measurements': [{'value': '6.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Change in Descent Time after fitting and acclimation', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Four Step Square Test (FSST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline FSST', 'categories': [{'measurements': [{'value': '13.5', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': 'FSST after fitting and acclimation', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Activities-specific Balance Confidence (ABC) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline ABC', 'categories': [{'measurements': [{'value': '72.4', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '72.4', 'spread': '9.73', 'groupId': 'OG001'}]}]}, {'title': 'Change in ABC after fitting and acclimation', 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.83', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '8.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline PLUS-M T-Score', 'categories': [{'measurements': [{'value': '50.0', 'spread': '6.64', 'groupId': 'OG000'}, {'value': '50', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'Change in PLUS T-Score after fitting and acclimation', 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': "The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample (i.e., people with unilateral amputation).", 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Amputee Body Image Scale (ABIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline ABIS', 'categories': [{'measurements': [{'value': '55.1', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '13.01', 'groupId': 'OG001'}]}]}, {'title': 'Change in ABIS after fitting and acclimation', 'categories': [{'measurements': [{'value': '1.9', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '6.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Stumbles and Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C-Leg 3', 'description': 'The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}, {'id': 'OG001', 'title': 'C-Leg 4', 'description': 'The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)'}], 'classes': [{'title': 'Baseline number of stumbles', 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'Change in number of stumbles after fitting and acclimation', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Baseline number of falls', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Change in number of falls after fitting and acclimation', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days.', 'unitOfMeasure': 'number of stumbles or falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'All subjects were ask which knee they preferred after having been fitted and acclimatized to each (C-Leg 3, C-Leg 4 and the NMPK)'}], 'classes': [{'title': 'Number preferring the C-Leg 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Number preferring the C-Leg 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number preferring the NMPK', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 3rd study visit after having been fitted and acclimatized to each of the study devices', 'description': 'The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with preference data that completed the study were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C-Leg 3, Then C-Leg 4', 'description': 'The participants were first fitted with C-Leg 3 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 4 and allowed to accommodate for 30 days after which they were assessed.'}, {'id': 'FG001', 'title': 'C-Leg 4, Then C-Leg 3', 'description': 'The participants were first fitted with C-Leg 4 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 3 and allowed to accommodate for 30 days after which they were assessed.'}], 'periods': [{'title': 'First Intervention (90 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '5 subjects were excluded from the study prior to randomization: 3 subjects had adverse events, 1 subject could not be fitted with the intervention device due to anthropomorphic characteristics, and 1 subject withdrew due to a change in work situation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'C-Leg 3, Then C-Leg 4', 'description': 'C-Leg 4: Microprocessor Controlled Knee\n\nC-Leg 3: Microprocessor Controlled Knee'}, {'id': 'BG001', 'title': 'C-Leg 4, Then C-Leg 3', 'description': 'C-Leg 4: Microprocessor Controlled Knee\n\nC-Leg 3: Microprocessor Controlled Knee'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '4.95', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '177.4', 'spread': '7.54', 'groupId': 'BG000'}, {'value': '172.13', 'spread': '9.40', 'groupId': 'BG001'}, {'value': '174.15', 'spread': '8.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.4', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '73.9', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '74.1', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since amputation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '23.6', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '22.54', 'spread': '17.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Amputation side', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'left', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'right', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Amputation type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Transfemoral', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Knee disarticulation', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medicare Functional Classification Level (MFCL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Medicare Functional Classification Level (MFCL) was adopted in 1995 by the US Centers for Medicare and Medicaid Services using 5 levels for classifying functional mobility and rehabilitation potential of individuals with lower limb loss. Level 0 does not have the ability or potential to ambulate or transfer safely. Level 1 is a household ambulator. Level 2 is a limited community ambulator. Level 3 is a community ambulator, and Level 4 has higher prosthetic demands typical of the child, active adult or athlete.', 'unitOfMeasure': 'Participants'}, {'title': 'Current knee prosthesis (NMPK)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': '3R106', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '3R15', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '3R60', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '3R80', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Polycentric', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Multiaxial', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Amputation cause', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'cancer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'infection', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'trauma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'vascular disease', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hours of wearing prosthesis per day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '12.4', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Distance covered per day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '3.25', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '3.38', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'km', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-15', 'size': 6671678, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-02T18:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-17', 'studyFirstSubmitDate': '2016-05-02', 'resultsFirstSubmitDate': '2021-07-16', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-17', 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6 Minute Gait Test', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'A measure of walking endurance, the distance walked in meters after 6 minutes.'}], 'secondaryOutcomes': [{'measure': 'Change in 10 Meter Gait Test', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds'}, {'measure': 'Change in Stairs Assessment Index (SAI)', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded.'}, {'measure': 'Change in Hill Assessment Index (HAI)', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded.'}, {'measure': 'Change in Four Step Square Test (FSST)', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction.'}, {'measure': 'Change in Activities-specific Balance Confidence (ABC) Scale', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.'}, {'measure': 'Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': "The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample (i.e., people with unilateral amputation)."}, {'measure': 'Change in Amputee Body Image Scale (ABIS)', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern.'}, {'measure': 'Change in Number of Stumbles and Falls', 'timeFrame': 'Baseline and after acclimation period (30-90 days after fitting)', 'description': 'Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days.'}, {'measure': 'Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)', 'timeFrame': 'At 3rd study visit after having been fitted and acclimatized to each of the study devices', 'description': 'The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lower Limb Amputation Above Knee (Injury)']}, 'descriptionModule': {'briefSummary': 'The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.', 'detailedDescription': 'During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person is \\>18 years old.\n* Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb.\n* Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL).\n* Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months.\n* Person was never fitted with microprocessor controlled prosthetic knee joint.\n* Person is willing and able to independently provide informed consent.\n* Person is willing to comply with study procedures.\n* Person wears prosthesis daily and ≥ 8 hours/day.\n* Person is walking on average 1km/day.\n* Person is walking not slower than 3km/h (\\~0.8m/s) (based on 10m walk test conducted during recruiting).\n* Person is walking on level ground in a step over step manner.\n\nExclusion Criteria:\n\n* Person is under 18 years of age.\n* Person who weighs more than 136kg.\n* Person who weighs less than 50kg.\n* Person who is pregnant.\n* Person has a history of chronic skin breakdown on the residual limb.\n* Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking).\n* Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system).\n* Person is using under arm axillary crutches or walker.\n* Person in an emergency, life threatening situation.\n* Person is unwilling/unable to follow instructions.\n* Person who is not available to follow the entire study protocol.\n* Person who is participating in another study or intends to participate in another study during this study duration.\n* Person who cannot personally provide their consent.\n* Person who is not wearing prosthesis 8hours/day on average.\n* Person who has a score on 10m walk test less than 3km/h (\\~0.8m/s) (based on 10m walk test conducted during recruiting).\n* Person who walks on average less than 1km per day.\n* Person who is not able to walk on level ground in a step over step manner.'}, 'identificationModule': {'nctId': 'NCT02765035', 'briefTitle': 'C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otto Bock Healthcare Products GmbH'}, 'officialTitle': 'A Randomized, Blinded, Cross-over Trial to Evaluate the Safety, Functional Mobility and Satisfaction of the Microprocessor Controlled Prosthetic Knee Component C-Leg 4 in Transfemoral Amputees', 'orgStudyIdInfo': {'id': 'PD-PS00120010A-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-Leg 3, then C-Leg 4', 'description': 'Participants are first fitted with a C-Leg 3, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 4, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.', 'interventionNames': ['Device: C-Leg 4', 'Device: C-Leg 3']}, {'type': 'EXPERIMENTAL', 'label': 'C-Leg 4, then C-Leg 3', 'description': 'Participants are first fitted with a C-Leg 4, receive physical therapy, acclimate for 90 days and are then assessed in the clinic. They then receive a C-Leg 3, receive additional physical therapy and acclimate for 30 days after which they are again assessed in the clinic.', 'interventionNames': ['Device: C-Leg 4', 'Device: C-Leg 3']}], 'interventions': [{'name': 'C-Leg 4', 'type': 'DEVICE', 'description': 'Microprocessor Controlled Knee', 'armGroupLabels': ['C-Leg 3, then C-Leg 4', 'C-Leg 4, then C-Leg 3']}, {'name': 'C-Leg 3', 'type': 'DEVICE', 'description': 'Microprocessor Controlled Knee', 'armGroupLabels': ['C-Leg 3, then C-Leg 4', 'C-Leg 4, then C-Leg 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7161', 'city': 'Sankt Andrä am Zicksee', 'state': 'Burgenland', 'country': 'Austria', 'facility': 'Orthopedic Rehabilitation Center SKA Zicksee', 'geoPoint': {'lat': 47.7841, 'lon': 16.94195}}, {'zip': '3212', 'city': 'Pellenberg', 'country': 'Belgium', 'facility': 'University Leuven', 'geoPoint': {'lat': 50.87245, 'lon': 4.79394}}], 'overallOfficials': [{'name': 'Stephan Domayer, Prim.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Rehabilitation Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data for primary and secondary outcome measures will be made available within one year of study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otto Bock Healthcare Products GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}