Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT01135160
Status:
TERMINATED
Last Update Posted:
2024-10-18
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Weight Bearing After Total Hip and Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'The planned number of patients was achieved.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'full weight bearing allowed and accomplished end of 6th week', 'timeFrame': '6 weeks', 'description': 'full weight bearing allowed and accomplished, documented by special soles with an electronic device, which will record weight bearing continuously on an USB stick'}], 'secondaryOutcomes': [{'measure': 'pain under partial weight bearing (recommended)', 'timeFrame': '6 weeks', 'description': 'Patients will have a official standardised pain diary and should document their pain and need of analgetics according to instructions given (VAS, "Schweizer Krebsliga") at least on a daily basis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weight bearing', 'pain', 'total hip arthroplasty', 'total knee arthroplasty', 'weight bearing after TKA or THA'], 'conditions': ['Arthropathy of Hip', 'Arthropathy of Knee']}, 'descriptionModule': {'briefSummary': "The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot between orthopedic surgeons concerning weight bearing. The type of implant and the way of implants' anchoring are considered.\n\nIn the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA.\n\nOver a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six.\n\nThe investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients receiving TKA or THA at our institution between August 2010 and August 2011', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* received a THA or TKA in the mentioned period of time\n* is able to walk on crutches\n* is able to understand our recommendations\n* signed informed consent\n\nExclusion Criteria:\n\n* not able to walk on crutches\n* not able to understand our recommendations\n* other deformities of lower limbs'}, 'identificationModule': {'nctId': 'NCT01135160', 'briefTitle': 'Evaluation of Weight Bearing After Total Hip and Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Münsterlingen'}, 'officialTitle': 'Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement', 'orgStudyIdInfo': {'id': 'KSM 2010-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TKA/THA', 'description': 'All patients receiving TKA/THA meeting inclusion but not exclusion criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8596', 'city': 'Münsterlingen', 'state': 'Thurgau', 'country': 'Switzerland', 'facility': 'Kantonsspital Münsterlingen', 'geoPoint': {'lat': 47.63197, 'lon': 9.23271}}], 'overallOfficials': [{'name': 'Michael Schueler, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief of the department for orthopedic surgery Kantonsspital Münsterlingen, Schweiz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Münsterlingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}