Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:34 PM
Study NCT ID:
NCT07348835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-31', 'size': 224904, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-15T18:02', 'hasProtocol': True}, {'date': '2025-10-31', 'size': 172867, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-15T17:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, parallel-group study. Eligible patients undergoing primary total knee arthroplasty are randomized in a 1:1 ratio to either the medial parapatellar or subvastus surgical approach and followed concurrently. Outcomes are assessed longitudinally.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-09', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-09', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step Count (steps/day)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Step Count (steps/day)', 'timeFrame': 'Baseline', 'description': 'Recorded from patients iPhone Health App for 2 weeks preoperatively'}], 'secondaryOutcomes': [{'measure': 'Stride Length (m)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Distance Travelled (km)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Functional Range of Motion (degrees)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Tibial Range of Motion (degrees)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Cadence (steps/minute)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Walking Speed (m/s)', 'timeFrame': 'Through study completion, minimum 6 months', 'description': 'Continuously recorded from PIQ device after it is implanted during surgery'}, {'measure': 'Goniometric Functional Range of Motion', 'timeFrame': 'Preoperatively and at 6 weeks', 'description': 'Measured in degrees using a goniometer'}, {'measure': 'Surgical Side', 'timeFrame': 'Preoperatively', 'description': 'Left or Right'}, {'measure': 'Age', 'timeFrame': 'Preoperatively', 'description': 'In years, from EMR'}, {'measure': 'Sex', 'timeFrame': 'Preoperatively', 'description': 'Male or Female, from EMR'}, {'measure': 'Weight', 'timeFrame': 'Preoperatively', 'description': 'In kg, from EMR'}, {'measure': 'Height', 'timeFrame': 'Preoperatively', 'description': 'In cm, from EMR'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Preoperatively', 'description': 'in kg/m2, from EMR'}, {'measure': 'Comorbidities', 'timeFrame': 'Preoperatively', 'description': 'Collected and listed from EMR'}, {'measure': 'Charlson Comorbidity Index (CCI)', 'timeFrame': 'Preoperatively', 'description': 'Calculated from formula using comorbidities collected from EMR'}, {'measure': 'Time to Achieving Key Milestones in Daily Activities', 'timeFrame': '6 weeks postoperatively', 'description': 'Survey score collected (less time = better), Survey via Force Therapeutics'}, {'measure': 'Veterans Rand 12-Item (VR-12) Health Survey', 'timeFrame': 'Preoperatively, 6 weeks postoperatively, 6 months postoperatively', 'description': 'Mental and Physical component survey scores collected (0-100); Survey via Force Therapeutics'}, {'measure': 'Procedure Satisfaction', 'timeFrame': '6 weeks postoperatively', 'description': 'Survey score collected (0-5; 5 best), Survey via Force Therapeutics'}, {'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Preoperatively, 6 weeks postoperatively', 'description': 'Survey score collected (0-10; 0 best), Survey via Force Therapeutics'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)', 'timeFrame': 'Preoperatively, 6 weeks postoperatively, 6 months postoperatively', 'description': 'Survey score collected (0-100; 100 best), Survey via Force Therapeutics'}, {'measure': 'Forgotten Joint Score (FJS)', 'timeFrame': 'Preoperatively, 6 weeks postoperatively, 6 months postoperatively', 'description': 'Survey score collected (0-100; 100 best), Survey via Force Therapeutics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Medial Parapatellar Approach', 'Subvastus Approach'], 'conditions': ['Total Knee Anthroplasty']}, 'referencesModule': {'references': [{'pmid': '10693563', 'type': 'BACKGROUND', 'citation': 'Matsueda M, Gustilo RB. Subvastus and medial parapatellar approaches in total knee arthroplasty. Clin Orthop Relat Res. 2000 Feb;(371):161-8. doi: 10.1097/00003086-200002000-00020.'}, {'pmid': '28947369', 'type': 'BACKGROUND', 'citation': 'Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016/j.arth.2017.08.025. Epub 2017 Aug 30.'}, {'pmid': '11880904', 'type': 'BACKGROUND', 'citation': 'Cila E, Guzel V, Ozalay M, Tan J, Simsek SA, Kanatli U, Ozturk A. Subvastus versus medial parapatellar approach in total knee arthroplasty. Arch Orthop Trauma Surg. 2002 Mar;122(2):65-8. doi: 10.1007/s004020100319.'}, {'pmid': '24897738', 'type': 'BACKGROUND', 'citation': 'Tomek IM, Kantor SR, Cori LA, Scoville JM, Grove MR, Morgan TS, Swarup I, Moschetti WE, Spratt KF. Early Patient Outcomes After Primary Total Knee Arthroplasty with Quadriceps-Sparing Subvastus and Medial Parapatellar Techniques: A Randomized, Double-Blind Clinical Trial. J Bone Joint Surg Am. 2014 Jun 4;96(11):907-915. doi: 10.2106/JBJS.L.01578. Epub 2014 Jun 4.'}, {'type': 'BACKGROUND', 'citation': 'Sukeik M, Sohail MZ, Hossain FS, AlShryda S, Powell J. Comparing the Sub-Vastus and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Short-Term Outcomes. Dr Sulaiman Al Habib Med J. 2021;3(2):66. doi:10.2991/dsahmj.k.210203.001'}, {'pmid': '34408867', 'type': 'BACKGROUND', 'citation': 'Khan MNH, Abbas K, Faraz A, Ilyas MW, Shafique H, Jamshed MH, Hashmi P. Total knee replacement: A comparison of the subvastus and medial parapatellar approaches. Ann Med Surg (Lond). 2021 Aug 8;68:102670. doi: 10.1016/j.amsu.2021.102670. eCollection 2021 Aug.'}, {'pmid': '20953864', 'type': 'BACKGROUND', 'citation': 'van Hemert WL, Senden R, Grimm B, van der Linde MJ, Lataster A, Heyligers IC. Early functional outcome after subvastus or parapatellar approach in knee arthroplasty is comparable. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):943-51. doi: 10.1007/s00167-010-1292-0. Epub 2010 Oct 17.'}, {'pmid': '29657848', 'type': 'BACKGROUND', 'citation': 'Berstock JR, Murray JR, Whitehouse MR, Blom AW, Beswick AD. Medial subvastus versus the medial parapatellar approach for total knee replacement: A systematic review and meta-analysis of randomized controlled trials. EFORT Open Rev. 2018 Mar 26;3(3):78-84. doi: 10.1302/2058-5241.3.170030. eCollection 2018 Mar.'}], 'seeAlsoLinks': [{'url': 'https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-iq.html', 'label': 'Persona IQ Device'}]}, 'descriptionModule': {'briefSummary': 'This is a single-institution, prospective, randomized study comparing the medial parapatellar and subvastus approaches in primary total knee arthroplasty using continuous, implant-based gait monitoring. Patients receiving a Zimmer Persona IQ smart implant will be followed preoperatively and through the first 30 days post-operatively, with extended follow-up to 6 months. Preoperative activity is captured using iPhone Health step-count data, while post-operative recovery is assessed using continuous tibial implant data, including step count, range of motion, cadence, walking speed, stride length, and distance. These objective metrics are correlated with PROMs. The primary outcome is daily step count. Secondary outcomes include early functional milestones, pain, and patient-reported functional scores. This study is designed to characterize early recovery trajectories and determine whether meaningful differences exist between surgical approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients older than 18 years of age who plan to undergo medial congruent polyethylene bearing primary TKA with a PIQ\n* Eligible for both approaches\n* Have an iPhone and willing to "wear" it for two weeks preoperatively to get an estimated average stepcount\n* Provide informed consent\n* Willing to complete follow ups\n\nExclusion Criteria:\n\n* Patients with TKA revisions\n* Patients with insufficient pre-operative range of motion in the operative knee (flexion contracture of \\> 20 degrees or \\< 90° of knee flexion)\n* Patients with Contralateral TKA within study time frame\n* Patients with TKA other than medial congruent polyethylene bearing\n* Patients with bilateral surgery\n* Patients without a valid and active email address\n* Patients not willing or able to participate in study and follow-ups\n* Patients who use assisted devices to ambulate\n* Rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT07348835', 'briefTitle': 'Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches', 'organization': {'class': 'NETWORK', 'fullName': 'Total Joint Specialists'}, 'officialTitle': 'Continuous Monitoring Using a Smart Implantable Device (Persona IQ®) to Compare Medial Parapatellar vs. Subvastus Approaches in Early Post-Operative Total Knee Arthroplasty Recovery', 'orgStudyIdInfo': {'id': 'NSH1432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medial Parapatellar Approach', 'description': 'Primary total knee arthroplasty performed using the medial parapatellar surgical approach', 'interventionNames': ['Procedure: Total Knee Arthroplasty Medial Parapatellar Approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subvastus Approach', 'description': 'Primary total knee arthroplasty performed using the subvastus surgical approach', 'interventionNames': ['Procedure: Total Knee Arthroplasty Subvastus Approach']}], 'interventions': [{'name': 'Total Knee Arthroplasty Medial Parapatellar Approach', 'type': 'PROCEDURE', 'description': 'Incision splitting quad', 'armGroupLabels': ['Medial Parapatellar Approach']}, {'name': 'Total Knee Arthroplasty Subvastus Approach', 'type': 'PROCEDURE', 'description': 'quad-sparing approach', 'armGroupLabels': ['Subvastus Approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Zachary M Ricciardelli, B.S.', 'role': 'CONTACT', 'email': 'zach.ricciardelli@gmail.com', 'phone': '(615)-957-0334'}, {'role': 'CONTACT', 'email': 'zach.ricciardelli@gmail.com'}, {'name': 'Thomas L Bradbury, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zachary M Ricciardelli, B.S.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charlotte C Baker, B.S.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Total Joint Surgery Center Atlanta', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}], 'centralContacts': [{'name': 'Thomas L Bradbury, M.D.', 'role': 'CONTACT', 'email': 'tombradburymd@gmail.com', 'phone': '(404)-759-3912'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will only be used as necessary by the authorized research team and always secured, it will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Total Joint Specialists', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}