Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-04-15 @ 3:01 PM
Study NCT ID:
NCT02720159
Status:
UNKNOWN
Last Update Posted:
2016-03-25
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant', 'timeFrame': '1 year'}, {'measure': 'Changes in Bone Mineral Density as collected using DEXA scan', 'timeFrame': '1 year'}, {'measure': 'Changes in implant exit site using Modified Holgers Skin Metric', 'timeFrame': '1 yr'}, {'measure': 'Analyze measurable changes in the stoma punch', 'timeFrame': '1 year'}, {'measure': 'Analyze changes of walking and standing', 'timeFrame': '1 year', 'description': 'Three dimensional motion capture of walking and standing through a calibration volume that contains force plates'}, {'measure': 'Analyze changes in metabolic efficiency', 'timeFrame': '1 year', 'description': 'Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.'}, {'measure': 'Analyze changes in 6 minute walk test', 'timeFrame': '1 year'}, {'measure': 'Assess changes in Donning and Doffing prosthetic time', 'timeFrame': '1 year'}, {'measure': 'Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test', 'timeFrame': '1 year'}, {'measure': 'Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions', 'timeFrame': '1 yr'}, {'measure': 'Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)', 'timeFrame': '1 yr'}, {'measure': "Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions", 'timeFrame': '1 yr'}, {'measure': 'Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function', 'timeFrame': '1 yr'}, {'measure': 'Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting', 'timeFrame': '1 yr'}, {'measure': 'Changes in at-home prosthetic usage using StepWatch activity monitor', 'timeFrame': '1 yr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Traumatic Amputee']}, 'referencesModule': {'references': [{'pmid': '35908658', 'type': 'DERIVED', 'citation': 'Sinclair S, Beck JP, Webster J, Agarwal J, Gillespie B, Stevens P, Gililland J, Kubiak E. The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2092-2104. doi: 10.1016/j.apmr.2022.06.008. Epub 2022 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* US Military veteran with transfemoral amputation that is not a result of dysvascular disease\n* Has used or is using a "socket suspension technology" prosthesis\n* Use of non-propulsive, passive microprocessor-regulated devices\n* Agrees not to participate in high levels of physical activity while in the study\n* Subject meets anatomical and eligibility criteria for the investigational device\n\nExclusion Criteria:\n\n* Currently on active military duty\n* More than 1 limb amputated\n* Has insulin dependent or adult onset diabetes\n* Recent tobacco use'}, 'identificationModule': {'nctId': 'NCT02720159', 'acronym': 'POP', 'briefTitle': 'Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis', 'orgStudyIdInfo': {'id': 'POP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TREATMENT', 'interventionNames': ['Device: Percutaneous Osseintegrated Prosthesis']}], 'interventions': [{'name': 'Percutaneous Osseintegrated Prosthesis', 'type': 'DEVICE', 'armGroupLabels': ['TREATMENT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarina Sinclair, PhD', 'role': 'CONTACT', 'email': 'sarina.sinclair@va.gov', 'phone': '801-582-1565'}, {'name': 'Erik Kubiak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'George E. Wahlen Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encore Medical, L.P.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'VA Salt Lake City Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}