Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00690651
Status:
COMPLETED
Last Update Posted:
2010-06-09
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004434', 'term': 'Early Ambulation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-08', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of acute hospital stay', 'timeFrame': 'various', 'description': 'The time frame is variable as the length of stay is variable depending on many factors (usually less than a week in acute hospital if no complications)'}], 'secondaryOutcomes': [{'measure': 'wound integrity', 'timeFrame': '10-14 days'}, {'measure': 'readmission rate', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ankle', 'fracture', 'mobilisation', 'bed rest', 'internal fixation'], 'conditions': ['Ankle Injuries', 'Fracture']}, 'descriptionModule': {'briefSummary': 'After a patient has fractured an ankle that then requires surgery, the recommendation is to remain in bed, with the operated leg elevated on pillows for 48 hours. This is a precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can lead to other complications such as blood clots in the lungs or leg veins, or chest infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss of fitness such that recovery may be slower. In this research the investigators will be randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed for 48 hours with their leg well elevated. The investigators will measure length of stay and wound healing and integrity at 14 days. This study aims to investigate whether getting patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute hospital length of stay without affecting wound healing. If bed rest for 2 days is not necessary, there will be benefits for the patient in terms of general health and ability, and for the hospital in terms of cost savings through shorter lengths of stay and patient through put. The investigators already know that early mobilization is beneficial following other types of orthopedic surgery such as hip fractures. This study aims to investigate if early mobilization following surgical management of ankle fractures is safe with specific regard to wound integrity and wound outcomes. This study will also investigate the effect of earlier mobilization on the length of time spent in the acute hospital and for those discharged directly home, the amount and type of support required. If early mobilization is found to be safe for wound healing and results in shorter in-hospital stays, this research will provide the confidence to endorse a change to current clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy\n\nExclusion Criteria:\n\n* living in nursing home,\n* previously non-ambulant,\n* concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy'}, 'identificationModule': {'nctId': 'NCT00690651', 'briefTitle': 'Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Randomized Controlled Study Into Early Mobilization Following Internal Fixation of Isolated Ankle Fractures.', 'orgStudyIdInfo': {'id': '166/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'this group will rest in bed with operated leg well elevated for 48 hour and then mobilize with physiotherapist with aim for discharge home when safe.', 'interventionNames': ['Procedure: Standard mobilization']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'mobilize with physiotherapist within 24 hours of surgical fixation of fractured ankle', 'interventionNames': ['Procedure: Early mobilization']}], 'interventions': [{'name': 'Early mobilization', 'type': 'PROCEDURE', 'description': 'pt to get out of bed and mobilize with physiotherapist within 24 hours of surgery. they will be allowed toilet privileges and will go home when safe (as per medical staff and allied health)', 'armGroupLabels': ['1']}, {'name': 'Standard mobilization', 'type': 'PROCEDURE', 'description': 'this group will rest in bed with their leg elevated above their heart for 48 hours post surgery to ankle fracture and will then mobilize with physiotherapist with aim to discharge home.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3204', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Lara a Kmmel, BA. Physio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bayside Health'}, {'name': 'Anne Holland, Dr Physio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayside Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Trauma Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ms Lara kimmel', 'oldOrganization': 'The Alfred'}}}}