Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 6:06 AM
Study NCT ID:
NCT03077958
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with degenerative knee disease randomely receive one of two types of total knee prostheses'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford Knee Score (OKS)', 'timeFrame': 'Preoperatively to 2 years', 'description': 'The Oxford Knee Score (OKS) is a 12-item patient-reported outcome measure (PROM) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction is reported on a visual analogue scale (VAS) 1-10', 'timeFrame': 'Preoperatively to 2 years', 'description': 'Patient satisfaction is reported on a visual analogue scale (VAS) 1-10'}, {'measure': 'Knee Kinematics, (anterior-posterior translations and axial rotations)', 'timeFrame': '2 years', 'description': 'Dynamic radiostereometric analysis with detailed recordings of the threedimensional motions of the knee during a step-up'}, {'measure': 'Pain (VAS)', 'timeFrame': 'Preoperatively to 2 years', 'description': 'Patient pain reported on Visual Analogue Scales(VAS) 1-10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthrosis, Knee']}, 'descriptionModule': {'briefSummary': '100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomisation will be done using envelopes. Patients can only participate with one knee.', 'detailedDescription': 'The Attune total knee replacement is a recently developed implant with the intention to improve the outcome after this procedure. One of the primary aims is to improve the kinematics of the knee in order to more closely mimic the normal knee. Thereby the patients are expected to experience improved function, better stability and less pain during activity. So far there are no randomized studies which have demonstrated this potential superior performance when compared to its predecessor, the PFC Sigma TKR. This study aims to evaluate the clinical outcome and the knee kinematics of the Attune knee using recognized clinical outcome parameters and dynamic radiostereometry. The PFC sigma knee will be used as control.\n\n100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the Attune or PFC total knee arthroplasty. Randomization will be done using envelopes. Patients can only participate with one knee.\n\nSurgical procedure: The operations will be done according to our routines without use of bloodless field. Local analgesia will be infiltrated periarticulary during the operation. Cemented fixation will be used in all cases. So-called "fast-track"principles will be applied in both Groups.\n\nPatients will be followed for five years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with degenerative joint disease of the knee on our waiting list for a total knee replacement will be asked to participate in this study\n\nInclusion Criteria:\n\n* Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4\n* Varus or valgus deformity ≤15 degrees, extension defect ≤15 degrees\n* BMI \\<35\n* ASA 1-3.\n* Coming from independent living in own home\n* Written informed consent\n\nExclusion Criteria:\n\n* Cortisone treatment during the last 6 months before operation\n* Neurological diseases with symptoms, stroke with sequel\n* Endocrine diseases with symptoms\n* OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities\n* BMI \\>=35\n* OA of the hip with symptoms. (Patients operated with total hip arthroplasty are accepted)\n* Ongoing infection\n* Unable or unwilling to participate in the follow-up.'}, 'identificationModule': {'nctId': 'NCT03077958', 'acronym': 'Att16SM', 'briefTitle': 'Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma. Randomised Study of 50 Attune and 50 PFC Sigma Total Knee Replacements (TKRs)', 'orgStudyIdInfo': {'id': 'Attune2016SM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total Knee Replacement (2 different design)', 'type': 'PROCEDURE', 'otherNames': ['Attune or PFC Sigma TKR'], 'description': 'Patients will randomely receive either Attune or PFC Sigma TKR'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-43180', 'city': 'Mölndal', 'state': 'Västra Götaland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan N Kärrholm, MD', 'role': 'CONTACT', 'email': 'nils.karrholm@vgregion.se', 'phone': '+46313422847'}, {'name': 'Thom Magnusson, MD', 'role': 'CONTACT', 'email': 'thom.magnusson@vgregion.se', 'phone': '+46313430861'}], 'facility': 'Department of Orthopaedics', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}], 'centralContacts': [{'name': 'Johan N Kärrholm, MD, PhD', 'role': 'CONTACT', 'email': 'nils.karrholm@vgregion.se', 'phone': '+46313428247'}, {'name': 'Thom Magnusson, MD', 'role': 'CONTACT', 'email': 'thom.magnusson@vgregion.se', 'phone': '+46705403085'}], 'overallOfficials': [{'name': 'Johan Kärrholm, MD PhD Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared with the sponsor (DePuy).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Professor in Orthopaedics', 'investigatorFullName': 'Johan Karrholm', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}