Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-04 @ 11:53 AM
Study NCT ID:
NCT04525950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2020-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotized Navigation Compared to Conventional Technique in Total Knee Replacement
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': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are blinded as the Navio system will be switched on at all operations, the outcomes assessors, statisticians and co-researchers will not get access to the randomization information.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, blinded (patient and outcomes assessor), clinical and radiostereometric trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Position of the implant on radiographs, coronal and sagittal plane', 'timeFrame': '3 months', 'description': 'Femoral/tibial components: varus/valgus and flexion/extension, off-set of the femoral component'}], 'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders', 'timeFrame': '3 months', 'description': 'Difference in rate (0.00-1.00) of high responders (calculated from KOOS)'}, {'measure': 'WOMAC high responders', 'timeFrame': '1 year', 'description': 'Difference in rate (0.00-1.00) of high responders (calculated from KOOS)'}, {'measure': 'WOMAC high responders', 'timeFrame': '2 years', 'description': 'Difference in rate (0.00-1.00) of high responders (calculated from KOOS)'}, {'measure': 'WOMAC high responders', 'timeFrame': '5 years', 'description': 'Difference in rate (0.00-1.00) of high responders (calculated from KOOS)'}, {'measure': 'Radiostereometric migration', 'timeFrame': '1 year', 'description': 'Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)'}, {'measure': 'Radiostereometric migration', 'timeFrame': '2 years', 'description': 'Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)'}, {'measure': 'Radiostereometric migration', 'timeFrame': '5 years', 'description': 'Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)'}], 'secondaryOutcomes': [{'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': '3 months', 'description': 'Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0(worse)-100(better))'}, {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': '1 year', 'description': 'Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)'}, {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': '2 years', 'description': 'Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)'}, {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': '5 years', 'description': 'Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)'}, {'measure': 'Knee society score (KSS)', 'timeFrame': '3 months', 'description': 'Knee society score, knee score (0(worse)-100(better)) and function score (0(worse)-100(better))'}, {'measure': 'Knee society score (KSS)', 'timeFrame': '1 year', 'description': 'Knee society score, knee score (0-100) and function score (0-100)'}, {'measure': 'Knee society score (KSS)', 'timeFrame': '2 years', 'description': 'Knee society score, knee score (0-100) and function score (0-100)'}, {'measure': 'Knee society score (KSS)', 'timeFrame': '5 years', 'description': 'Knee society score, knee score (0-100) and function score (0-100)'}, {'measure': 'EQ-5D', 'timeFrame': '3 months', 'description': 'Euroqol, quality of life (0(worse)-100(better))'}, {'measure': 'EQ-5D', 'timeFrame': '1 year', 'description': 'Euroqol, quality of life (0-100)'}, {'measure': 'EQ-5D', 'timeFrame': '2 years', 'description': 'Euroqol, quality of life (0-100)'}, {'measure': 'EQ-5D', 'timeFrame': '5 years', 'description': 'Euroqol, quality of life (0-100)'}, {'measure': 'Visual analogue scale (VAS)', 'timeFrame': 'pre-op, 3 months, 1 year, 2 years, 5 years', 'description': 'Visual Analogue Scale pain (0(worse)-100(better))'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': '3 months', 'description': 'Forgotten Joint Score (0(worse)-100(better))'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': '1 year', 'description': 'Forgotten Joint Score (0-100)'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': '2 years', 'description': 'Forgotten Joint Score (0-100)'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': '5 years', 'description': 'Forgotten Joint Score (0-100)'}, {'measure': 'Maximum climb-up test', 'timeFrame': '3 months', 'description': 'Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)'}, {'measure': 'Maximum climb-up test', 'timeFrame': '1 year', 'description': 'Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)'}, {'measure': 'Anchor questions', 'timeFrame': '2 years', 'description': 'Are you satisfied with the outcome? Would you do it again?'}, {'measure': 'Anchor questions', 'timeFrame': '5 years', 'description': 'Are you satisfied with the outcome? Would you do it again?'}, {'measure': 'Timed 40 meters walking test', 'timeFrame': '3 months', 'description': 'Time spent walking 40 meters'}, {'measure': 'Timed 40 meters walking test', 'timeFrame': '1 year', 'description': 'Time spent (in seconds) walking 40 meters'}, {'measure': 'Chair test 30 seconds', 'timeFrame': '3 months', 'description': 'number of repetitions from sitting to standing position during 30 seconds'}, {'measure': 'Chair test 30 seconds', 'timeFrame': '1 year', 'description': 'number of repetitions from sitting to standing position during 30 seconds'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis, Degenerative', 'Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '30066017', 'type': 'BACKGROUND', 'citation': 'Batailler C, White N, Ranaldi FM, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1232-1240. doi: 10.1007/s00167-018-5081-5. Epub 2018 Jul 31.'}, {'pmid': '30063588', 'type': 'BACKGROUND', 'citation': 'Petursson G, Fenstad AM, Gothesen O, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Furnes O. Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 1;100(15):1265-1274. doi: 10.2106/JBJS.17.01338.'}, {'pmid': '31256672', 'type': 'BACKGROUND', 'citation': 'Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1.'}, {'pmid': '31950265', 'type': 'BACKGROUND', 'citation': 'Bollars P, Boeckxstaens A, Mievis J, Kalaai S, Schotanus MGM, Janssen D. Preliminary experience with an image-free handheld robot for total knee arthroplasty: 77 cases compared with a matched control group. Eur J Orthop Surg Traumatol. 2020 May;30(4):723-729. doi: 10.1007/s00590-020-02624-3. Epub 2020 Jan 16.'}, {'pmid': '9699158', 'type': 'BACKGROUND', 'citation': 'Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.'}, {'pmid': '9863983', 'type': 'BACKGROUND', 'citation': 'Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. doi: 10.1111/j.1600-0838.1998.tb00465.x.'}, {'pmid': '31711349', 'type': 'BACKGROUND', 'citation': 'Heijbel S, Naili JE, Hedin A, W-Dahl A, Nilsson KG, Hedstrom M. The Forgotten Joint Score-12 in Swedish patients undergoing knee arthroplasty: a validation study with the Knee Injury and Osteoarthritis Outcome Score (KOOS) as comparator. Acta Orthop. 2020 Feb;91(1):88-93. doi: 10.1080/17453674.2019.1689327. Epub 2019 Nov 12.'}, {'pmid': '23617377', 'type': 'BACKGROUND', 'citation': 'Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.'}, {'pmid': '26327798', 'type': 'BACKGROUND', 'citation': 'Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.'}, {'pmid': '23966416', 'type': 'BACKGROUND', 'citation': 'Nyberg LA, Hellenius ML, Wandell P, Kowalski J, Sundberg CJ. Maximal step-up height as a simple and relevant health indicator: a study of leg muscle strength and the associations to age, anthropometric variables, aerobic fitness and physical function. Br J Sports Med. 2013 Oct;47(15):992-7. doi: 10.1136/bjsports-2013-092577. Epub 2013 Aug 21.'}, {'pmid': '24788494', 'type': 'BACKGROUND', 'citation': 'Gothesen O, Espehaug B, Havelin LI, Petursson G, Hallan G, Strom E, Dyrhovden G, Furnes O. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J. 2014 May;96-B(5):609-18. doi: 10.1302/0301-620X.96B5.32516.'}, {'pmid': '29514366', 'type': 'BACKGROUND', 'citation': 'Inui H, Taketomi S, Yamagami R, Shirakawa N, Kawaguchi K, Tanaka S. The Relationship between Soft-Tissue Balance and Intraoperative Kinematics of Guided Motion Total Knee Arthroplasty. J Knee Surg. 2019 Jan;32(1):91-96. doi: 10.1055/s-0038-1636545. Epub 2018 Mar 7.'}, {'pmid': '31488934', 'type': 'BACKGROUND', 'citation': 'Iriuchishima T, Ryu K. Bicruciate Substituting Total Knee Arthroplasty Improves Stair Climbing Ability When Compared with Cruciate-Retain or Posterior Stabilizing Total Knee Arthroplasty. Indian J Orthop. 2019 Sep-Oct;53(5):641-645. doi: 10.4103/ortho.IJOrtho_392_18.'}, {'pmid': '31031156', 'type': 'BACKGROUND', 'citation': "Harris AI, Christen B, Malcorps JJ, O'Grady CP, Kopjar B, Sensiba PR, Vandenneucker H, Huang BK, Cates HE, Hur J, Marra DA. Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties. J Arthroplasty. 2019 Jul;34(7S):S201-S208. doi: 10.1016/j.arth.2019.02.011. Epub 2019 Feb 14."}, {'pmid': '30972466', 'type': 'BACKGROUND', 'citation': 'Kono K, Inui H, Tomita T, Yamazaki T, Taketomi S, Sugamoto K, Tanaka S. Bicruciate-stabilised total knee arthroplasty provides good functional stability during high-flexion weight-bearing activities. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2096-2103. doi: 10.1007/s00167-019-05375-9. Epub 2019 Apr 10.'}, {'pmid': '31821293', 'type': 'BACKGROUND', 'citation': 'Di Benedetto P, Buttironi MM, Magnanelli S, Cainero V, Causero A. Comparison between standard technique and image-free robotic technique in medial unicompartmental knee arthroplasty. Preliminary data. Acta Biomed. 2019 Dec 5;90(12-S):104-108. doi: 10.23750/abm.v90i12-S.8994.'}, {'pmid': '23934905', 'type': 'BACKGROUND', 'citation': 'Unver B, Kahraman T, Kalkan S, Yuksel E, Karatosun V. Reliability of the six-minute walk test after total hip arthroplasty. Hip Int. 2013 Nov-Dec;23(6):541-5. doi: 10.5301/hipint.5000073. Epub 2013 Aug 6.'}, {'pmid': '27996349', 'type': 'BACKGROUND', 'citation': 'Petursson G, Fenstad AM, Gothesen O, Haugan K, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Nilsson KG, Furnes O. Similar migration in computer-assisted and conventional total knee arthroplasty. Acta Orthop. 2017 Apr;88(2):166-172. doi: 10.1080/17453674.2016.1267835. Epub 2016 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal.\n\nThis study investigates whether this advanced technology leads to better clinical or radiostereometric results, by comparing one group operated with Navio to another group operated with conventional technique.', 'detailedDescription': 'Background:\n\nThe scientific foundation of total knee replacement (TKR) surgery is incomplete. As a national governor of joint replacements, the Norwegian Arthroplasty Register is obligated to strict regulations, demanding high levels of evidence for implants and instruments utilized by Norwegian surgeons. It is well known that 15-20% of patients with a TKR, are dissatisfied. Nevertheless, only a small proportion of these patients have revision surgery.\n\nIn this randomized, clinical trial we will use the Journey II BCS total knee system, with a more native anatomical design, intended to improve the kinematics and functional outcomes by mimicking a native knee, with respect to geometry and its interplay with the ligaments and soft tissue envelope of the knee (i.e. the biomechanics; stability, joint line, off-set, sizing etc.). To achieve an optimal placement of the implant, the surgeon needs to assess a lot of information (experience) during the surgical procedure. To secure this process, and to make sure all aspects are taken into account, with respect to an optimal positioning and ligament balancing, the computer navigation technique may offer valuable input, with further enhancement of the accuracy and precision using precision tools like the Navio from Smith \\& Nephew. The Navio system combines robotics and computer navigation, and represents the newest technology within surgical robotics and haptics. This trial is important in the mandatory evaluation process needed, before introducing new technology into orthopaedic surgery, on a larger scale.\n\nMethods:\n\nThe surgeons involved have been trained at a wet lab, and on saw bones, before utilizing this tool in a live setting. After the introduction period, the training will continue in a clinical setting until the surgeons have operated at least 20 Navio assisted cases each, followed by a pilot study of 10 patients. All patients will be randomized to either Navio or Conventional technique.\n\nSurgical method: A tourniquet is used. All implant components are cemented (Palacos R+G bone cement is utilized 10 minutes after retrieval from a 4 degrees Celsius refrigerator). Standard para-patellar approach. ACL and PCL are removed. Closing of the wound and capsule in mid-flexion position, Quill for the capsule, Vicryl for the subcutaneous tissue, continuous overlapping mattress with Ethilon suture for the skin. No drainage. Wrapping of the entire limb with elastic dressings for the first 48 hours. Prophylactic antibiotics and anticoagulants are given. Tranexamic acid to reduce bleeding. Postop pain medication: gabapentin, acetaminophen, naproxen, femoral triangle nerve block (repeated next day if needed).\n\nFor the conventional group: The rotational alignment is set according to Whiteside\'s line, and intramedullary rods with 5, 6 or 7 degrees valgus, are selected for the distal femoral cut (dependent on pre-operatively measured angles on long radiographs (hip-knee-ankle). The entry hole of the rod is plugged with bone from the femur to reduce bleeding from the intramedullary canal. The tibial component (metal) is positioned with a 3 degrees posterior slope.\n\nFor the Navio group: The cuts are navigated to optimize ligament balance in flexion and extension, and adjusted for mid-flexion instability when needed. A difference of less than 4 mm between lateral and medial gaps is accepted when the laxity is on the lateral side, preferably in flexion. However, if the gap balancing technique suggests a deviation from mechanical alignment of more than 2 degrees of valgus or 4 degrees of varus, the suggestion is overruled by the mechanical alignment (maximum 2 degrees valgus, less than 4 degrees varus).\n\nSample size calculations: To detect a clinically important difference of 0.17 in the rate of "high responders" and "non-responders" (OMERACT-OARSI criteria) to the Navio, with a standard deviation of 20, power 80% and a 0.05 significance level, a total of 194 patients must be included in the trial (97 patients in each group). The calculations are based on data from a previous study, by Petursson et al, JBJS Am 2018. When 10% eventual drop-outs are taken into account, the total number of patients to be included is 214 (107 patients in each group).\n\nA large number of patients is important, as the expected difference between the groups is small. A small difference may be less clinically relevant, however, may contribute to an overall better outcome for the patients in total. A small improvement of the tools combined with other small improvements may add up to be clinically important in the end. Small trials with no significant differences may disqualify important small improvements, thus stopping any further development in the field. Consequently, large clinical trials will be valuable.\n\nA radiostereometric analysis constitutes a separate study of the trial. A clinically relevant difference of 0.1 mm between the groups will be detected with a standard deviation of 0.1, power 80% and significance level 0.05, if 17 patients are included in each group. Including eventual drop-outs and an expectation of some failures due to the technically challenging investigation method (the RSA), a total of 30 patients will be included in each group. RSA radiographs will be collected within the first week after the operation, at 3 months, 1 year, 2 years and 5 years follow-ups.\n\nThe trial is approved by the regional ethics committee and the data inspectorate of Norway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Degenerative knee in need of a total knee arthroplasty\n* Recruited from the hospital's waiting list\n* Informed consent\n\nExclusion Criteria:\n\n* Severe systemic illness\n* Infections\n* Severe neurological dysfunction\n* Severe cancer disease\n* Severe incompensated heart failure\n* Severe incompensated lung disease\n* Dementia\n* Previous fracture or deformity of the limb, making the use of an intramedullary rod impossible (same side hip or ankle implant is not to be excluded if the rod unaffectedly reaches more than the first half of the femoral canal)"}, 'identificationModule': {'nctId': 'NCT04525950', 'acronym': 'NavioRCT', 'briefTitle': 'Robotized Navigation Compared to Conventional Technique in Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Robotized Computer Navigation Versus Conventional Technique in Total Knee Replacement. A Randomized, Clinical and Radiostereometric Trial.', 'orgStudyIdInfo': {'id': '2020/68448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navio', 'description': 'Using the new technology during surgery', 'interventionNames': ['Procedure: Navio']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Using the conventional surgical instruments', 'interventionNames': ['Procedure: Conventional']}], 'interventions': [{'name': 'Navio', 'type': 'PROCEDURE', 'description': 'New generation computer navigation with haptics and robotics', 'armGroupLabels': ['Navio']}, {'name': 'Conventional', 'type': 'PROCEDURE', 'description': 'Total knee arthroplasty using conventional instruments', 'armGroupLabels': ['Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5504', 'city': 'Haugesund', 'state': 'Haugesund', 'country': 'Norway', 'facility': 'Haugesund sanitetsforenings revmatismesykehus', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland university hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Ove Furnes, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bergen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Haugesund Rheumatism Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}