Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02102334
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2014-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D007870', 'term': 'Leg Length Inequality'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-29', 'studyFirstSubmitDate': '2014-03-29', 'studyFirstSubmitQcDate': '2014-03-29', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg Length Discrepancy', 'timeFrame': '1 week', 'description': 'LLD on radiographs was defined as the difference in perpendicular distance in millimetres between a line passing through the lower edge of the teardrop points to the corresponding tip of the lesser trochanter. The interobserver reliability was assessed from the measurements made by three independent observers.'}, {'measure': 'Femoral offset (Sundsvall method)', 'timeFrame': '1 week', 'description': 'Measurement of FO using the Sundsvall method was carried out on the AP view of the pelvis as the horizontal distance (parallel to Hilgenreiners line) between the femoral axis (a line drawn through the center of the femoral shaft) and the mid line of the pelvis, at the height of the lateral tip of the greater trochanter. The measurement was performed bilaterally to compare the femoral offset on the operated side to the non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.'}, {'measure': 'Femoral offset (standard method)', 'timeFrame': '1 week', 'description': 'Measurement of FO with the standard method was carried out on AP view as the addition of the distance between the longitudinal axis of the femur to center of femoral head and the distance from the center of the femoral head to a perpendicular line passing through the medial edge of the ipsilateral teardrop point of the pelvis. The measurement was repeated bilaterally to compare the FO of the operated side to non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.'}, {'measure': 'Cup inclination', 'timeFrame': '1 week', 'description': 'Cup inclination was measured on AP view as angle in degrees, between a line drawn along the angle of rim of the cup and trans-ischial line (a line drawn between the most inferior point of the ischial tuberosities). The interobserver reliability was assessed from the measurements made by three independent observers.'}, {'measure': 'Acetabular cup anteversion', 'timeFrame': '1 week', 'description': 'Acetabular cup anteversion was measured on lateral radiograph as the angle formed by the intersection of a line drawn across the face of acetabulum and a line perpendicular to the horizontal plane, according to the Woo and Morry method. The interobserver reliability was assessed from the measurements made by three independent observers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis, hip,', 'radiograpghic measurements', 'femoral offset', 'leg length discrepancy', 'cup anteversion', 'cup inclination'], 'conditions': ['Osteoarthritis of the Hip']}, 'referencesModule': {'references': [{'pmid': '20041386', 'type': 'BACKGROUND', 'citation': 'Kjellberg M, Englund E, Sayed-Noor AS. A new radiographic method of measuring femoral offset. The Sundsvall method. Hip Int. 2009 Oct-Dec;19(4):377-81. doi: 10.1177/112070000901900413.'}, {'pmid': '19423418', 'type': 'BACKGROUND', 'citation': 'Lecerf G, Fessy MH, Philippot R, Massin P, Giraud F, Flecher X, Girard J, Mertl P, Marchetti E, Stindel E. Femoral offset: anatomical concept, definition, assessment, implications for preoperative templating and hip arthroplasty. Orthop Traumatol Surg Res. 2009 May;95(3):210-9. doi: 10.1016/j.otsr.2009.03.010. Epub 2009 May 6.'}, {'pmid': '22560563', 'type': 'BACKGROUND', 'citation': 'Gililland JM, Anderson LA, Boffeli SL, Pelt CE, Peters CL, Kubiak EN. A fluoroscopic grid in supine total hip arthroplasty: improving cup position, limb length, and hip offset. J Arthroplasty. 2012 Sep;27(8 Suppl):111-6. doi: 10.1016/j.arth.2012.03.027. Epub 2012 May 3.'}, {'pmid': '15736733', 'type': 'BACKGROUND', 'citation': 'Konyves A, Bannister GC. The importance of leg length discrepancy after total hip arthroplasty. J Bone Joint Surg Br. 2005 Feb;87(2):155-7. doi: 10.1302/0301-620x.87b2.14878.'}, {'pmid': '12111881', 'type': 'BACKGROUND', 'citation': 'Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med. 2002 May 15;21(9):1331-5. doi: 10.1002/sim.1108.'}, {'pmid': '10065720', 'type': 'BACKGROUND', 'citation': 'Woolson ST, Hartford JM, Sawyer A. Results of a method of leg-length equalization for patients undergoing primary total hip replacement. J Arthroplasty. 1999 Feb;14(2):159-64. doi: 10.1016/s0883-5403(99)90119-5.'}, {'pmid': '22547373', 'type': 'BACKGROUND', 'citation': 'Wylde V, Maclean A, Blom AW. Post-operative radiographic factors and patient-reported outcome after total hip replacement. Hip Int. 2012 Mar-Apr;22(2):153-9. doi: 10.5301/HIP.2012.9225.'}, {'pmid': '18437379', 'type': 'BACKGROUND', 'citation': 'Wylde V, Whitehouse SL, Taylor AH, Pattison GT, Bannister GC, Blom AW. Prevalence and functional impact of patient-perceived leg length discrepancy after hip replacement. Int Orthop. 2009 Aug;33(4):905-9. doi: 10.1007/s00264-008-0563-6. Epub 2008 Apr 25.'}, {'pmid': '19412648', 'type': 'BACKGROUND', 'citation': 'Little NJ, Busch CA, Gallagher JA, Rorabeck CH, Bourne RB. Acetabular polyethylene wear and acetabular inclination and femoral offset. Clin Orthop Relat Res. 2009 Nov;467(11):2895-900. doi: 10.1007/s11999-009-0845-3. Epub 2009 May 2.'}, {'pmid': '21938375', 'type': 'BACKGROUND', 'citation': 'Patel SR, Toms AP, Rehman JM, Wimhurst J. A reliability study of measurement tools available on standard picture archiving and communication system workstations for the evaluation of hip radiographs following arthroplasty. J Bone Joint Surg Am. 2011 Sep 21;93(18):1712-9. doi: 10.2106/JBJS.J.00709.'}, {'pmid': '21491155', 'type': 'BACKGROUND', 'citation': 'Kjellberg M, Al-Amiry B, Englund E, Sjoden GO, Sayed-Noor AS. Measurement of leg length discrepancy after total hip arthroplasty. The reliability of a plain radiographic method compared to CT-scanogram. Skeletal Radiol. 2012 Feb;41(2):187-91. doi: 10.1007/s00256-011-1166-7. Epub 2011 Apr 14.'}, {'pmid': '21296551', 'type': 'BACKGROUND', 'citation': 'Moskal JT, Capps SG. Acetabular component positioning in total hip arthroplasty: an evidence-based analysis. J Arthroplasty. 2011 Dec;26(8):1432-7. doi: 10.1016/j.arth.2010.11.011. Epub 2011 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'In total hip arthroplasty (THA), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD) require good validity, interobserver reliability and intraobserver reproducibility.\n\nQuestions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and anteversion.\n\n90 patients with primary unilateral osteoarthritis (OA) were included in this prospective study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability and intraobserver reproducibility were made by three independent observers. The validity and degree of prediction of Sundsvall method are measured by comparing its results with the standard method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '90 consecutive patients with primary unilateral osteoarthritis (OA) who underwent THA between September 2010 and June 2012 were recruited into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral total hip replacement with either a cemented Lubinus SP II system (Link, Germany) or an uncemented CLS stem and Triology cup (Zimmer, U.S.A).\n\nExclusion Criteria:\n\n* Patient with secondary (OA), previous spinal, pelvic, or lower limb injuries or fractures were excluded.'}, 'identificationModule': {'nctId': 'NCT02102334', 'briefTitle': 'Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sundsvall Hospital'}, 'officialTitle': 'Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'RMVL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unilateral osteoarthritis', 'description': 'Patients operated with a total hip replacement due to unilateral osteoarthritis of the hip. Radiographic measurements of the postoperative radiographs.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '856 43', 'city': 'Sundsvall', 'state': 'Västernorrland County', 'country': 'Sweden', 'facility': 'Sundsvall hostpital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}], 'overallOfficials': [{'name': 'Arkan S Sayed-Noor, MD,PhD,FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sundsvall Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Lennart Bråbäck', 'investigatorAffiliation': 'Sundsvall Hospital'}}}}