Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-05 @ 5:29 PM
Study NCT ID:
NCT02906735
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Plantar Pressure After Knee Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot pressure curve preoperatively', 'timeFrame': '-1 day', 'description': 'scale'}], 'secondaryOutcomes': [{'measure': 'Foot pressure curve postoperatively', 'timeFrame': '1 year', 'description': 'scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Pain Treated With Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planned for knee surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for knee surgery willing to participate at this study\n\nExclusion Criteria:\n\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT02906735', 'acronym': 'PEDKnee', 'briefTitle': 'Changes of Plantar Pressure After Knee Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Evaluation of Static and Dynamic Foot Pressure Measurement After Implantation of Knee Joint Prostheses or Alignment Surgeries of the Knee', 'orgStudyIdInfo': {'id': 'TUM1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with knee surgery undergo plantar foot pressure measurement pre- and postoperatively', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Implantation of knee joint prosthesis or deviation osteotomies of the knee', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Norbert Harrasser, DR.', 'role': 'CONTACT', 'email': 'norbert.harrasser@gmx.net', 'phone': '00498941405229'}, {'name': 'Ingo Banke, Dr.', 'role': 'CONTACT', 'email': 'ingo@banke.eu', 'phone': '00498941405284'}], 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Norbert Harrasser', 'role': 'CONTACT', 'email': 'norbert.harrasser@gmx.net', 'phone': '15232716657'}], 'overallOfficials': [{'name': 'Norbert Harrasser', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Harrasser', 'investigatorAffiliation': 'Technical University of Munich'}}}}