Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-26 @ 8:11 PM
Study NCT ID:
NCT02316704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-02-09
First Post:
2014-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2014-12-06', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.', 'timeFrame': '2 year', 'description': 'Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.\n\n * Participants must be 18-75 years of age.\n * Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).\n * Participants must be able to give informed consent and be cognitively intact.\n * Participants must be expected to be able to complete all postoperative controls.\n * Participants must not have severe comorbidities, ASA-score ≤ 3.\n\nExclusion Criteria:\n\n* Terminal illness.\n* Rheumatoid arthritis.\n* Previous fracture of the hip.\n* Osteonecrosis of the hip.\n* Previous infection of the hip.\n* Severe bony deformity warranting the use of non-standard implants.\n* Metastasis in the periarticular bone or proximal femur.\n* Female patients that are pregnant or planning pregnancy during follow-up period\n* If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.\n* Documented osteoporosis with patient in active medical treatment.\n* Comorbidity with altered pain perception (e.g. DM with neuropathy).\n* Participants that develop deep infection in the follow-up period are excluded from the project.'}, 'identificationModule': {'nctId': 'NCT02316704', 'briefTitle': 'Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome', 'orgStudyIdInfo': {'id': 'G7_RSA_v1.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OsseoTi™ G7 large', 'description': 'OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)', 'interventionNames': ['Device: THA with G7 PPS coted acetabular component', 'Device: THA with G7 OsseoTi coted acetabular component']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OsseoTi™ G7 32', 'description': 'OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head', 'interventionNames': ['Device: THA with G7 PPS coted acetabular component', 'Device: THA with G7 OsseoTi coted acetabular component']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional PPS coated G7 large', 'description': 'conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)', 'interventionNames': ['Device: THA with G7 PPS coted acetabular component', 'Device: THA with G7 OsseoTi coted acetabular component']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional PPS coated G7 32', 'description': 'conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head', 'interventionNames': ['Device: THA with G7 PPS coted acetabular component', 'Device: THA with G7 OsseoTi coted acetabular component']}], 'interventions': [{'name': 'THA with G7 PPS coted acetabular component', 'type': 'DEVICE', 'armGroupLabels': ['OsseoTi™ G7 32', 'OsseoTi™ G7 large', 'conventional PPS coated G7 32', 'conventional PPS coated G7 large']}, {'name': 'THA with G7 OsseoTi coted acetabular component', 'type': 'DEVICE', 'armGroupLabels': ['OsseoTi™ G7 32', 'OsseoTi™ G7 large', 'conventional PPS coated G7 32', 'conventional PPS coated G7 large']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': 'SW-431 80', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital, Department of Orthopedics,', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Kirill Gromov', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}