Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 12:45 PM
Study NCT ID:
NCT03035435
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Knee Society Score', 'timeFrame': 'Change from Baseline fast-track rehabilitation at 8th and 15th day'}, {'measure': "Merle D'Aubigne' scale", 'timeFrame': 'Change from Baseline fast-track rehabilitation at 8th and 15th day'}], 'secondaryOutcomes': [{'measure': 'Barthel Index', 'timeFrame': 'Change from Baseline fast-track rehabilitation at 8th and 15th day'}]}, 'conditionsModule': {'keywords': ['fast-track rehabilitation', 'fast-track surgery'], 'conditions': ['Knee Arthroplasty', 'Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': "In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment will take place to Rehabilitation Unit of Don Gnocchi Foundation of Rovato (Brescia, Italy), from January 2016 to August 2016. An informed consent will be signed by each participant in agreement with Helsinki Declaration. The study is approved by the local Ethical Committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult people (\\>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb\\>9 g/l).\n\nExclusion Criteria:\n\n* the presence of pain measured with NRS (NRS\\>4)\n* rheumatoid arthritis, past surgery\n* cancer\n* neurological and psychiatric disorders\n* dementia with Minimental Test\\<24\n* pregnancy\n* participation in the other clinical studies.'}, 'identificationModule': {'nctId': 'NCT03035435', 'briefTitle': 'Fast-track Rehabilitation After Total Knee or Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study', 'orgStudyIdInfo': {'id': 'Fast Track Rehab'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'fast-track rehabilitation', 'interventionNames': ['Other: fast-track rehabilitation']}, {'label': 'control group', 'description': 'standard care rehabilitation', 'interventionNames': ['Other: standard care rehabilitation']}], 'interventions': [{'name': 'fast-track rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['study group']}, {'name': 'standard care rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chiara Arienti, PhD(s)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Don Gnocchi Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Chiara Arienti', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}