Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-03-20 @ 4:41 PM
Study NCT ID:
NCT01807104
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2011-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wpbarrett@comcast.net', 'phone': '425-656-5060', 'title': 'Dr. William P. Barrett, MD', 'phoneExt': '3063', 'organization': 'VOA Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 years', 'eventGroups': [{'id': 'EG000', 'title': 'Direct Anterior Approach', 'description': 'Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 5, 'seriousNumAtRisk': 43, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Postero-Lateral Approach', 'description': 'Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 6, 'seriousNumAtRisk': 44, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Anterior Approach', 'description': 'Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.'}, {'id': 'OG001', 'title': 'Postero-Lateral Approach', 'description': 'Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '10.89', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '15.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Direct Anterior Approach', 'description': 'Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.'}, {'id': 'FG001', 'title': 'Postero-Lateral Approach', 'description': 'Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Direct Anterior Approach', 'description': 'Direct Anterior Approach (DAA) utilizing a modern fracture table with the patient placed supine, both feet in boots for proper positioning. Anterior skin incision, 10-14 cm long, is used. An inter-muscular plane is utilized to access the anterior hip capsule. The hip capsule is opened anteriorly, a femoral neck osteotomy is performed based on pre-operative templating, and the femoral head removed. Acetabular retractors are placed and reaming of the acetabulum commenced. This is done under direct visualization with C-arm confirmation for positioning. The femoral side is then visualized with the aid of the fracture table. A hydraulic trochanteric hook elevates the proximal femur. Broaching of the femoral canal is started and proceeds up to the appropriate size. A trial reduction is performed, and the length and offset are checked manually and with C-arm confirmation. The trial components are removed and the prostheses are placed with press-fit fixation. Routine closure is performed.'}, {'id': 'BG001', 'title': 'Postero-Lateral Approach', 'description': 'Postero-Lateral Approach (PA) uses a standard OR table with the patient placed in the lateral decubitus position. A 10-14 cm skin incision is utilized over the posterior-lateral corner of the hip. The gluteus maximus muscle is split in line with its fibers and the short external rotators and posterior capsule are opened. The hip is dislocated posteriorly and a femoral neck osteotomy is performed. The acetabular and femoral components are inserted in the same manner as is done with the DAA with press fit fixation utilized. The PA is well described in all major texts on orthopedic surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '63.0', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-01-28', 'size': 405529, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-29T17:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2011-06-16', 'resultsFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-25', 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach', 'timeFrame': '5 years', 'description': 'Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Approach', 'Posterior Approach'], 'conditions': ['Osteoarthritis of the Hip']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.arth.2019.01.060', 'label': 'Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up Evaluation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).', 'detailedDescription': 'The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.\n\nThe posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is able to or capable of providing consent to participate in the clinical investigation.\n2. Subject is between the ages of 20-75 years, inclusive.\n3. Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)\n4. Subject has sufficient bone stock for the hip replacement device.\n5. Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.\n\nExclusion Criteria:\n\n1. Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.\n2. Subject has had previous surgery on the affected hip.\n3. Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.'}, 'identificationModule': {'nctId': 'NCT01807104', 'briefTitle': 'Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach', 'organization': {'class': 'INDIV', 'fullName': 'Barrett, William, M.D.'}, 'officialTitle': 'Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach', 'orgStudyIdInfo': {'id': '20091819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior Approach Total Hip', 'description': 'Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach', 'interventionNames': ['Procedure: Anterior Approach / Posterior Approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Posterior Approach Total Hip', 'description': 'The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach.', 'interventionNames': ['Procedure: Anterior versus Posterior Approach for total hip replacement']}], 'interventions': [{'name': 'Anterior Approach / Posterior Approach', 'type': 'PROCEDURE', 'description': 'compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach', 'armGroupLabels': ['Anterior Approach Total Hip']}, {'name': 'Anterior versus Posterior Approach for total hip replacement', 'type': 'PROCEDURE', 'description': 'Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach', 'armGroupLabels': ['Posterior Approach Total Hip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Valley Orthopedic Associates', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'William P Barrett, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barrett, William, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'William Barrett,M.D,', 'investigatorFullName': 'William Barrett, M.D.', 'investigatorAffiliation': 'Barrett, William, M.D.'}}}}