Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-13 @ 9:17 AM
Study NCT ID:
NCT02805751
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2016-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D017695', 'term': 'Soft Tissue Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modulus of Elasticity', 'timeFrame': '19 weeks', 'description': 'Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.'}], 'secondaryOutcomes': [{'measure': 'Tendon elongation', 'timeFrame': '2, 7, 19 and 52 weeks after rupture', 'description': 'Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads'}, {'measure': 'Modulus of Elasticity', 'timeFrame': '7 and 52 weeks after rupture', 'description': 'Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.'}, {'measure': 'Achilles tendon total rupture score (ATRS)', 'timeFrame': '19 and 52 weeks after rupture', 'description': 'Patient reported outcome regarding function in their Achilles tendon'}, {'measure': 'Maximal range of motion', 'timeFrame': '19 and 52 weeks after rupture', 'description': 'The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.'}, {'measure': 'Heel-rise', 'timeFrame': '19 and 52 weeks after rupture', 'description': 'The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.'}, {'measure': 'Plastic deformation of the tendon', 'timeFrame': '7 weeks after rupture', 'description': 'Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.'}, {'measure': 'Calf muscle circumference', 'timeFrame': '19 and 52 weeks', 'description': 'Measurement of the circumference at the thickest part of the calf'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Achilles', 'Tendon', 'Loading', 'Rehabilitation'], 'conditions': ['Tendon Injuries', 'Soft Tissue Injuries', 'Achilles Tendon Rupture']}, 'referencesModule': {'references': [{'pmid': '36005394', 'type': 'DERIVED', 'citation': 'Rendek Z, Bon Beckman L, Schepull T, Danmark I, Aspenberg P, Schilcher J, Eliasson P. Early Tensile Loading in Nonsurgically Treated Achilles Tendon Ruptures Leads to a Larger Tendon Callus and a Lower Elastic Modulus: A Randomized Controlled Trial. Am J Sports Med. 2022 Oct;50(12):3286-3298. doi: 10.1177/03635465221117780. Epub 2022 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).\n\nThe hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.', 'detailedDescription': 'Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures.\n\nThe patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson).\n\nAfter 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA.\n\nThe patients are thereafter randomized to early controlled loading or control.\n\nAll patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture.\n\nThe patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture.\n\nAfter the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures.\n\nMechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52.\n\nThe elastic modulus of the tendon at 19 weeks it the primary variable of this study.\n\nAt week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52.\n\nThe overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks.\n\nComplications and re-ruptures will be registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon\n* Presented within 14 days from injury\n* 18-60 years old\n\nExclusion Criteria:\n\n* Inability to understand swedish\n* previous injured tendon\n* Diabetes mellitus\n* History of Rheumatoid disease\n* Treatment with steroids'}, 'identificationModule': {'nctId': 'NCT02805751', 'briefTitle': 'Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading', 'orgStudyIdInfo': {'id': 'Early loading'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.', 'interventionNames': ['Other: Tendon strain exercises', 'Other: Early weight bearing']}, {'type': 'EXPERIMENTAL', 'label': 'Early loading', 'description': 'The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).', 'interventionNames': ['Device: Early loading on a training pedal', 'Other: Tendon strain exercises', 'Other: Early weight bearing']}], 'interventions': [{'name': 'Early loading on a training pedal', 'type': 'DEVICE', 'description': 'The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.', 'armGroupLabels': ['Early loading']}, {'name': 'Tendon strain exercises', 'type': 'OTHER', 'description': 'The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.', 'armGroupLabels': ['Control', 'Early loading']}, {'name': 'Early weight bearing', 'type': 'OTHER', 'description': 'The patients are allowed to bear weight as much as tolerated in the walker from day 1.', 'armGroupLabels': ['Control', 'Early loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58729', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'University Hospital Linkoeping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Per Aspenberg, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Pernilla Eliasson', 'investigatorAffiliation': 'Linkoeping University'}}}}