Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:20 AM
Study NCT ID:
NCT07342166
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale score for knee pain', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Kujala score', 'timeFrame': '3 months, 1 year'}, {'measure': 'Knee Society score', 'timeFrame': '3 months, 1 year'}, {'measure': 'Timed up and go test', 'timeFrame': '3 months, 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellar denervation', 'Total knee arthroplasty', 'Total knee replacement'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This study is a double-blind randomized controlled trial aiming to investigate the effects of patellar denervation using electrocautery on postoperative knee pain and knee function in patients undergoing primary total knee arthroplasty (TKA) without patellar resurfacing.', 'detailedDescription': 'This study is a prospective, double-blind randomized controlled trial conducted at Queen Savang Vadhana Memorial Hospital between 2023 and 2025. The aim of the study is to assess the effect of patellar denervation using electrocautery on postoperative knee pain and knee function in patients undergoing primary total knee arthroplasty (TKA) without patellar resurfacing.\n\nSixty-four patients were enrolled and randomly assigned to either the patellar denervation group (PD) or the non-denervation group (NPD), with 32 participants in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-85 years old\n* Knee osteoarthritis\n* Plan for total knee arthroplasty after failed conservative treatment for at least 3 months\n\nExclusion Criteria:\n\n* Previous history of trauma, fracture or open surgery on the same knee\n* Inflammatory arthritis or Crystal-induced arthritis\n* Patellar instability or isolated patellofemoral osteoarthritis\n* Unable to answer questionnaire\n* Cannot tolerate surgery due to medical comorbidities'}, 'identificationModule': {'nctId': 'NCT07342166', 'acronym': 'PD', 'briefTitle': 'Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '021/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patellar Denervation', 'interventionNames': ['Procedure: Patellar Denervation']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Patellar Denervation'}], 'interventions': [{'name': 'Patellar Denervation', 'type': 'PROCEDURE', 'description': 'Electrocautery patella circumferentially during total knee arthroplasty', 'armGroupLabels': ['Patellar Denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Chalathorn Kulthonchalanan', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data was save in form of Google sheet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}