Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-29 @ 4:07 AM
Study NCT ID:
NCT04420832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D000208', 'term': 'Acute Disease'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in functional outcome between patients treated surgically and non-surgically', 'timeFrame': '3 months', 'description': 'The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated test which combines both the height of each heel-rise and the number of repetitions.'}, {'measure': 'Difference in functional outcome between patients treated surgically and non-surgically', 'timeFrame': '6 months', 'description': 'The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance'}, {'measure': 'Difference in functional outcome between patients treated surgically and non-surgically', 'timeFrame': '12 months', 'description': 'The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance'}, {'measure': 'Difference in functional outcome between patients treated surgically and non-surgically', 'timeFrame': '24 months', 'description': 'The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance'}], 'secondaryOutcomes': [{'measure': 'Ultrasonography (US)', 'timeFrame': '6 months', 'description': 'Achilles tendon length - measured using US extended field of view'}, {'measure': 'Ultrasonography (US)', 'timeFrame': '12 months', 'description': 'Achilles tendon length - measured using US extended field of view'}, {'measure': 'Ultrasonography (US)', 'timeFrame': '24 months', 'description': 'Achilles tendon length - measured using US extended field of view'}, {'measure': 'Achilles Tendon Rupture Score (ATRS)', 'timeFrame': '3 months', 'description': 'Patient reported outcome measure (PROM) specific for achilles tendon rupture'}, {'measure': 'Achilles Tendon Rupture Score (ATRS)', 'timeFrame': '6 months', 'description': 'Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.'}, {'measure': 'Achilles Tendon Rupture Score (ATRS)', 'timeFrame': '12 months', 'description': 'Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.'}, {'measure': 'Achilles Tendon Rupture Score (ATRS)', 'timeFrame': '24 months', 'description': 'Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.'}, {'measure': 'Physical Activity Scale (PAS)', 'timeFrame': '3 months', 'description': 'PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.'}, {'measure': 'Physical Activity Scale (PAS)', 'timeFrame': '6 months', 'description': 'PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.'}, {'measure': 'Physical Activity Scale (PAS)', 'timeFrame': '12 months', 'description': 'PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.'}, {'measure': 'Physical Activity Scale (PAS)', 'timeFrame': '24 months', 'description': 'PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achilles Tendon Rupture', 'Athletic Injuries', 'Ultrasonography', 'Rupture', 'Acute Disease']}, 'descriptionModule': {'briefSummary': 'Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute achilles tendon rupture diagnosed less than 48 hours from injury\n* mid-substance rupture\n\nExclusion Criteria:\n\n* previous achilles tendon rupture\n* lower leg disability\n* diabetes mellitus\n* neurovascular disease\n* immunosuppression\n* non-Swedish speaker'}, 'identificationModule': {'nctId': 'NCT04420832', 'acronym': 'DUSTAR', 'briefTitle': 'Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture', 'orgStudyIdInfo': {'id': 'ATR ultrasound study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy', 'interventionNames': ['Procedure: Surgical treatment']}, {'type': 'OTHER', 'label': 'Non-surgical treatment', 'description': 'Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy', 'interventionNames': ['Other: Non-surgical treatment']}], 'interventions': [{'name': 'Surgical treatment', 'type': 'PROCEDURE', 'description': 'Se above', 'armGroupLabels': ['Surgical treatment']}, {'name': 'Non-surgical treatment', 'type': 'OTHER', 'description': 'See above', 'armGroupLabels': ['Non-surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'state': 'Västra Götalandsregionen', 'country': 'Sweden', 'facility': 'Department of Orthopedics', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Katarina Nilsson Helander, MD Ass Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Katarina Nilsson Helander', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}