Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-29 @ 7:59 PM
Study NCT ID:
NCT03704532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonoperative Treatment of Acute Achilles Tendor Rupture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '1 year', 'description': 'Isometric plantar flexion strength'}, {'measure': 'Gastrocnemius muscle cross-sectional area', 'timeFrame': '1 year', 'description': 'Lateral and medial gastrocnemius and soleus muscle area using ultrasound'}, {'measure': 'Tendon length', 'timeFrame': '1 year', 'description': 'Achilles tendon length using ultrasound'}, {'measure': 'Research ANd Development (RAND-36) quality of life', 'timeFrame': '1 year', 'description': 'Measurement of quality of life using RAND-36 questionnaire'}], 'primaryOutcomes': [{'measure': 'Rerupture rate', 'timeFrame': '1 year', 'description': 'Rate rerupture of a healed tendon after the end of the intervention'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': '1 year', 'description': 'Patient activity 1 year after the rupture using the Tegner activity level scale which varies from 0 to 10. This scale that aims to provide a standardized method of grading work and sporting activities.'}, {'measure': 'University of California, Los Angeles (UCLA) score', 'timeFrame': '1 year', 'description': 'Patient activity 1 year after the rupture'}, {'measure': 'Achilles tendon rupture score (ATRS)', 'timeFrame': '1 year', 'description': 'Achilles tendon rupture score 1 year after the rupture'}, {'measure': 'Functional Score', 'timeFrame': '1 year', 'description': 'Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100.'}, {'measure': 'Foot inversion', 'timeFrame': '1 year', 'description': 'Foot inversion angle in rest'}, {'measure': 'Foot flexion-extension', 'timeFrame': '1 year', 'description': 'Foot flexion-extension angle in rest'}, {'measure': 'Heel-raise test', 'timeFrame': '1 year', 'description': 'One leg heel-raise test while standing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['achilles tendon rupture', 'nonoperative treatment', 'functional rehabilitation', 'operative treatment', 'biomechanical measurements'], 'conditions': ['Achilles Tendon Rupture']}, 'referencesModule': {'references': [{'pmid': '39010659', 'type': 'DERIVED', 'citation': 'Sukanen M, Khair RM, Reito A, Ponkilainen V, Paloneva J, Cronin N, Hautala AJ, Finni T. Early Predictors of Recovery From Nonoperatively Treated Achilles Tendon Rupture: 1 Year Follow-Up Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14700. doi: 10.1111/sms.14700.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients having sustained an acute achilles tendon rupture and referred for either operative or nonoperative treatment with functional rehabilitation at our institution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute achilles tendon rupture with clear onset of symptoms\n* closed rupture\n* resides in the catchment area of our hospital district\n\nExclusion Criteria:\n\n* avulsion fractures in the calcaneus\n* unwillingness to participate\n* inability to communicate using Finnish language'}, 'identificationModule': {'nctId': 'NCT03704532', 'acronym': 'NoArc', 'briefTitle': 'Nonoperative Treatment of Acute Achilles Tendor Rupture', 'organization': {'class': 'OTHER', 'fullName': 'Central Finland Hospital District'}, 'officialTitle': 'Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2U/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operative treatment', 'description': 'Patients having undergone an operative treatment of achilles tendon rupture', 'interventionNames': ['Procedure: Operative treatment']}, {'label': 'Nonoperative treatment', 'description': 'Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture', 'interventionNames': ['Procedure: Nonoperative treatment']}], 'interventions': [{'name': 'Operative treatment', 'type': 'PROCEDURE', 'description': 'Open surgical repair of tendon rupture', 'armGroupLabels': ['Operative treatment']}, {'name': 'Nonoperative treatment', 'type': 'PROCEDURE', 'description': 'Nonoperative treatment with lower leg orthosis and functional rehabilitation', 'armGroupLabels': ['Nonoperative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40620', 'city': 'Jyväskylä', 'state': 'Central Finland', 'country': 'Finland', 'facility': 'Central Finland Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}], 'overallOfficials': [{'name': 'Juha Paloneva, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Central Finland Health Care District'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Finland Hospital District', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Jyvaskyla', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}