Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT04263493
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2020-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delayed Loading Following Repair of a Ruptured Achilles Tendon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-01', 'size': 213536, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-23T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heel-rise test', 'timeFrame': 'One-year follow-up', 'description': 'Heel-rise height deficit on the injured side relative to the uninjured side'}], 'secondaryOutcomes': [{'measure': 'Tendon length and cross-sectional area', 'timeFrame': '1 week, 3 months, 6 months and 1 year', 'description': 'MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion.'}, {'measure': 'The Achilles tendon rupture score (ATRS)', 'timeFrame': 'Recall before injury and 1 year', 'description': 'The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.'}, {'measure': 'Muscle fascicle length and doppler activity in the tendon', 'timeFrame': '2 weeks, 3 months, 6 months and 1 year', 'description': 'Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography'}, {'measure': 'Isokinetic plantar flexion muscle strength', 'timeFrame': '1 year', 'description': 'The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions.'}, {'measure': 'Physical activity level', 'timeFrame': 'Recall before injury and 1 year', 'description': 'A questionnaire is used to measure the physical activity level (including type of activity) of the participants.'}, {'measure': 'Heel-rise work', 'timeFrame': '6 months and 1 year', 'description': 'An instrumented heel-rise test will be conducted to measure work capacity'}, {'measure': 'The Achilles tendon resting angle (ATRA)', 'timeFrame': '2 weeks, 3 months, 6 months and 1 year', 'description': 'Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Achilles Tendon Surgery'], 'conditions': ['Achilles Tendon Rupture']}, 'referencesModule': {'references': [{'pmid': '41059465', 'type': 'DERIVED', 'citation': 'Hoeffner R, Svensson RB, Gillani SZ, Linden FH, Magnusson SP. Morphological Changes One Year After Achilles Tendon Rupture Repair: A Comparison of Loading Strategies. Transl Sports Med. 2025 Sep 28;2025:1778630. doi: 10.1155/tsm2/1778630. eCollection 2025.'}, {'pmid': '38353060', 'type': 'DERIVED', 'citation': 'Hoeffner R, Agergaard AS, Svensson RB, Cullum C, Mikkelsen RK, Konradsen L, Krogsgaard M, Boesen M, Kjaer M, Magnusson SP. Tendon Elongation and Function After Delayed or Standard Loading of Surgically Repaired Achilles Tendon Ruptures: A Randomized Controlled Trial. Am J Sports Med. 2024 Mar;52(4):1022-1031. doi: 10.1177/03635465241227178. Epub 2024 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.\n\nThe investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with a traumatic, complete mid-substance Achilles tendon\n* No contraindications for MRI\n* Presented within 14 days from injury\n* Adult (18 to 60 years)\n* Understand Danish\n* Manage transport to/from the hospital on their own\n\nExclusion Criteria:\n\n* Other injuries affecting their lower limb functions\n* Prior Achilles tendon Rupture\n* Smoking\n* Systemic diseases influencing tendon healing\n* Anticoagulation treatment\n* Inability to follow rehabilitation or complete follow-ups\n* Immunosuppressive treatment including systematic corticosteroid treatment'}, 'identificationModule': {'nctId': 'NCT04263493', 'acronym': 'DELOAT', 'briefTitle': 'Delayed Loading Following Repair of a Ruptured Achilles Tendon', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '01012020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early mobilization (loading)', 'description': 'This constitutes the currently accepted regime and is therefore considered the control group.\n\nCast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3', 'interventionNames': ['Other: Rehabilitation (physiotheraphy)']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed mobilization (loading)', 'description': 'Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3', 'interventionNames': ['Other: Rehabilitation (physiotheraphy)']}], 'interventions': [{'name': 'Rehabilitation (physiotheraphy)', 'type': 'OTHER', 'description': 'Time of loading, range of motion exercises, strength training', 'armGroupLabels': ['Delayed mobilization (loading)', 'Early mobilization (loading)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Peter Magnusson, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Sportsmedicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, MSc, PT', 'investigatorFullName': 'Rikke Høffner', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}