Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT01229293
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-21', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal muscle strength (Peak torque, Nm)', 'timeFrame': '52 wks post-surgery (primary endpoint)', 'description': 'Maximal muscle strength (peak torque, Nm) during maximal voluntary unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Both the affected (AF) and non-affected (NA) leg'}], 'secondaryOutcomes': [{'measure': 'Rapid force capacity (Rate of torque development, Nm/sec)', 'timeFrame': '52 wks post-surgery (primary endpoint)', 'description': 'Determined as the mean tangential slope of the torque-time curve in time intervals 0-100ms (RTD100ms), 0-200ms (RTD200ms) and 0-peak (RTD peak) relative to onset of contraction (t = 0ms)'}, {'measure': 'Gait parameters', 'timeFrame': '26 wks post-surgery (primary endpoint)', 'description': 'Selfselected, matched and maximal speed, limb index, Gait deviation index, Movement profile analysis togeter with tempo- spatial parameters'}, {'measure': 'Postural Control', 'timeFrame': '52 wks post-surgery (primary endpoint)', 'description': 'Sway analysis (postural control) during two-leg standing, tandem, one-leg standing and during transistion from sit-to-stand.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mechanical muscle function', 'Muscle strength', 'Hip replacement', 'Osteoarthritis', 'Hip arthroplasty'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '25957650', 'type': 'DERIVED', 'citation': 'Jensen C, Rosenlund S, Nielsen DB, Overgaard S, Holsgaard-Larsen A. The use of the Gait Deviation Index for the evaluation of participants following total hip arthroplasty: An explorative randomized trial. Gait Posture. 2015 Jun;42(1):36-41. doi: 10.1016/j.gaitpost.2015.02.009. Epub 2015 Apr 28.'}, {'pmid': '21749928', 'type': 'DERIVED', 'citation': 'Jensen C, Aagaard P, Overgaard S. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial. Osteoarthritis Cartilage. 2011 Sep;19(9):1108-16. doi: 10.1016/j.joca.2011.06.011. Epub 2011 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted at Odense University Hospital(OUH) in collaboration with Institute of Clinical Biomechanics and Sport Science, University of Southern Denmark and Clinical Institute, University of Southern Denmark\n\nAim: To evaluate the effect of implant design on postoperative total leg muscle function recovery and gait in hip replacement patients.\n\nDesign: A prospective randomized controlled clinical trial where patients are randomized into (A) total hip arthroplasty surgery (THA) or (B) resurfacing total hip replacement surgery (RTHA). Pre-surgery assessment and follow-up will be conducted at 8, 26 and 52 wks post-surgery.', 'detailedDescription': 'The project consist of three substudies:\n\n* Determination of test-retest reliability and agreement of specific mechanical muscle function variables for the patients of interest.\n* Evaluate the effect of implant design on postoperative mechanical muscle recovery\n* Evaluate the effect of implant design on postoperative gait'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary arthrosis\n\nExclusion Criteria:\n\n* Osteoporosis, (T-score \\< 2.5 SD) of proximal femur\n* BMI \\> 35\n* Severe acetabulum dysplasia (AP centre edge \\< 15-20°)\n* Femur anteversion \\> 25°\n* Severe caput deformity\n* Leg length discrepancy \\> 1 cm\n* Off-set problems\n* Earlier fracture of the ipsilateral proximal femur\n* Rheumatoid arthritis\n* Neuromuscular or vascular disease'}, 'identificationModule': {'nctId': 'NCT01229293', 'acronym': 'RTHA and THA', 'briefTitle': 'Gait Analysis and Neuromuscular Function After Primary Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'The Effect of Implant Design on Postoperative Mechanical Muscle Function Recovery and Gait in Hip Replacement Patients: A Randomized Clinical Trail', 'orgStudyIdInfo': {'id': 'VF20050133-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resurfacing Total Hip Arthroplasty', 'description': 'A hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint. Articular surface replacement ASR, DePuy posterolateral approach used (RTHA)', 'interventionNames': ['Procedure: Articular Surface Replacement (ASR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Total Hip Arthroplasty (THA)', 'description': 'A standard 28 mm head uncemented THA', 'interventionNames': ['Procedure: Standard Total Hip Arthroplasty (THA)']}], 'interventions': [{'name': 'Articular Surface Replacement (ASR)', 'type': 'PROCEDURE', 'description': 'Articular surface replacement, DePuy, posterolateral approach used', 'armGroupLabels': ['Resurfacing Total Hip Arthroplasty']}, {'name': 'Standard Total Hip Arthroplasty (THA)', 'type': 'PROCEDURE', 'description': 'Device: Biomet 28mm', 'armGroupLabels': ['Standard Total Hip Arthroplasty (THA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Orthopaedic Research Unit, Dept. of Orthopaedic Surgery and Traumatology, Odense University Hospital, Inst. of Clinical Research - University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Søren Overgaard, Prof., MD., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of the Interior and Health, Denmark', 'class': 'OTHER_GOV'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD-fellow', 'investigatorFullName': 'Carsten Jensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}