Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT05154058
Status:
TERMINATED
Last Update Posted:
2023-10-27
First Post:
2021-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medial Peel Release Technique TKA Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004564', 'term': 'Electrocoagulation'}], 'ancestors': [{'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'The Study was terminated due to principal investigator moving institutions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analogue Pain Scale (VAS)', 'timeFrame': 'Before and after surgery at the 3 month, 6 month, and 12 month follow-ups', 'description': 'The visual analog scale (VAS) is a tool used to measure pain. Patients will be asked to indicate their perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge .'}, {'measure': 'Change in Oxford Knee Score (OKS)', 'timeFrame': 'Before and after surgery at the 3 month, 6 month, and 12 month follow-ups', 'description': 'The Oxford Knee Score (OKS) is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty)'}, {'measure': 'Change in Incidence of Pes bursitis', 'timeFrame': '3 weeks, 3 months, 6 months, and 12 months post-operatively.', 'description': 'All patients will be seen post-operatively to monitor their progress and minimize risks, and the diagnosis of pes bursitis will be determined through clinical exam.'}], 'secondaryOutcomes': [{'measure': 'Changes in Varus valgus knee assessment', 'timeFrame': '3 weeks, 3 months, 6 months, and 12 months post-operatively.', 'description': "This assessment checks the lateral and medial collateral ligaments (ligaments on either side of the knee joint that help in back and forth movement of knee). In this test, the study doctor will hold the patient's knee joint with one hand and the ankle joint with the other, and moves the patient's leg sideways to asses the ligaments."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medial Subperiosteal Release'], 'conditions': ['Total Knee Arthroplasty', 'Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. This is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. The intervention will be randomly assigning subjects undergoing TKA into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.', 'detailedDescription': 'Medial release is a commonly performed technique to improve surgical exposure and aid in joint balancing. It is thought to be linked to the postoperative incidence of pes bursitis. However, the effect of scalpel vs electrocautery techniques for subperiosteal release has not been examined for their potential effect on the rates of pes bursitis. This randomized clinical trial will assign patients undergoing TKA for osteoarthritis (OA) into either scalpel or electrocautery release groups for their operation and will be followed postoperatively at 3 weeks and 3,6, and 12 months in order to determine the effect of release technique on rates of pes bursitis. This study will take place at Emory Orthopaedics. Subjects will not be compensated. Patients presenting to the clinic for evaluation of TKA will be screened for their eligibility in this study and recruited as well as consented in the clinic. This study can advance current clinical knowledge by evaluating two common surgical techniques to determine which may lead to better outcomes for patients undergoing TKA, a common orthopedic procedure, and reduce dissatisfaction as well as pain following operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over age 18\n* Patients undergoing primary TKA for osteoarthritis\n\nExclusion Criteria:\n\n* Patients undergoing revision TKA\n* Any patients not undergoing TKA for non-OA diagnosis\n* Adults unable to consent\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT05154058', 'briefTitle': 'Medial Peel Release Technique TKA Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis', 'orgStudyIdInfo': {'id': 'STUDY00003277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control: electrocautery', 'description': 'Primary patients with Osteoarthritis (OA) undergoing Total Knee arthroplasty (TKA) will be randomly assigned into either the control or investigational group. The control arm of the study will undergo medial sub periosteal release with electrocautery.', 'interventionNames': ['Procedure: Medial Subperiosteal Release with Electrocautery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Investigational: sharp dissection.', 'description': 'Primary patients with OA undergoing TKA will be randomly assigned into either the control or investigational group. The investigational arm will undergo medial sub periosteal release using sharp dissection.', 'interventionNames': ['Procedure: Medial Subperiosteal Release with Sharp Dissection']}], 'interventions': [{'name': 'Medial Subperiosteal Release with Sharp Dissection', 'type': 'PROCEDURE', 'otherNames': ['Medial Peel'], 'description': 'Medial subperiosteal release - a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery', 'armGroupLabels': ['Investigational: sharp dissection.']}, {'name': 'Medial Subperiosteal Release with Electrocautery', 'type': 'PROCEDURE', 'description': 'Medial subperiosteal release - a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This group will receive this procedure using electrocautery.', 'armGroupLabels': ['Control: electrocautery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Orthopaedics and Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At this time it will be an internal study with no sharing of de-identified patient information to third parties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ajay Premkumar', 'investigatorAffiliation': 'Emory University'}}}}