Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 8:34 PM
Study NCT ID:
NCT01106560
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2010-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach', 'timeFrame': 'on average up to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment of patient using the Harris Hip Score', 'timeFrame': 'pre-op and 6 weeks, 6 months, 1 year after surgery'}, {'measure': 'Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score', 'timeFrame': 'pre-op, 1 year post-op'}, {'measure': "Assessment of patient's level of activity using the UCLA score", 'timeFrame': 'pre-op and 6 weeks, 6 months, 1 year after surgery'}, {'measure': 'Radiological evaluation to assess the fixation and stability of femoral and acetabular components', 'timeFrame': 'pre-op and 6 weeks, 6 months, 1 year after surgery'}, {'measure': 'Strength Testing', 'timeFrame': '6 weeks, 6 months and 1y after surgery', 'description': 'Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100)'}, {'measure': 'MRI evaluation', 'timeFrame': 'preop-1y after surgery', 'description': 'A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100)'}, {'measure': 'Assessment of gait kinematics', 'timeFrame': '6 weeks, 12 weeks and 6 months', 'description': 'Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100)'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18-75 years at time of surgery.\n* Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.\n* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.\n* Patients who signed the study consent form prior to surgery.\n\nExclusion Criteria:\n\n* Pregnant women or women who plan to conceive in the future.\n* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.\n* Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).\n* Those with co-existent ipsilateral knee disease or back problems\n* Muscle contracture around the hip joint\n* Individuals who have undergone organ transplant.\n* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.\n* Individuals who have had a THR on the contra-lateral side within the 6 months.\n* Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \\< 16 points.\n* Individuals requiring bilateral hip replacement.\n* Individuals whose body mass index (BMI; kg/m2) \\>35.\n* Individuals with active or suspected infection or sepsis.\n* Individuals with renal failure and/or renal insufficiency.\n* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.'}, 'identificationModule': {'nctId': 'NCT01106560', 'briefTitle': 'A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach', 'orgStudyIdInfo': {'id': 'P01.004.12 rev.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior Approach Group', 'description': '(AMIS)', 'interventionNames': ['Procedure: Minimally Invasive Anterior Approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Posterior Approach Group', 'description': '(Posterior)', 'interventionNames': ['Procedure: Standard postero-lateral approach']}], 'interventions': [{'name': 'Minimally Invasive Anterior Approach', 'type': 'PROCEDURE', 'description': 'Anterior minimally invasive surgery (AMIS)', 'armGroupLabels': ['Anterior Approach Group']}, {'name': 'Standard postero-lateral approach', 'type': 'PROCEDURE', 'armGroupLabels': ['Posterior Approach Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT18 7EG', 'city': 'Epsom', 'country': 'United Kingdom', 'facility': 'The Elective Orthopaedic Centre (EOC)', 'geoPoint': {'lat': 51.3305, 'lon': -0.27011}}], 'overallOfficials': [{'name': 'Richard E Field, PhD FRCS(Orth)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Orthopaedic Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}