Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT06096792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Recovery After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle inhibition', 'timeFrame': 'postoperative day-1; postoperative day-2; postoperative day-3; postoperative 2th week and postoperative 6th week', 'description': 'Quadriceps maximum isometric muscle contraction will be evaluated by measuring the pneumatic pressure change with a pneumatic dynamometer.'}], 'secondaryOutcomes': [{'measure': 'Functional recovery', 'timeFrame': 'postoperative 2th week and postoperative 6th week', 'description': 'Five times sit to stand test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee arthroplasty', 'Knee osteoarthritis', 'muscle inhibition'], 'conditions': ['Knee Arthritis, Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Total knee arthroplasty (TKA) surgery is a common procedure performed to reduce pain, improve function, and enhance the quality of life in patients with end-stage knee osteoarthritis. As with other knee-related injuries and surgeries, TKA surgery can lead to inhibition of the quadriceps muscle, resulting in a decrease in the muscle's capacity to generate maximum voluntary force. This issue can negatively affect post-injury rehabilitation and function. The long-term persistent neuromuscular muscle inhibition in the quadriceps, one of the most important anti-gravity muscles in our body, leads to muscle atrophy and strength loss, which is more determinant in the development of functional limitations compared to joint range of motion and knee pain.\n\nThere have been no studies found that assess the quadriceps muscle inhibition occurring during the hospitalization of patients undergoing total knee arthroplasty surgery and examine its impact on post-discharge functional status.\n\nThe aim of this study is to evaluate the severity of arthrogenic inhibition in the quadriceps muscle of patients following total knee arthroplasty surgery, which is widely practiced in our country and considered the gold standard for the treatment of end-stage knee osteoarthritis. Additionally, the study aims to investigate its impact on post-discharge functional recovery. The data obtained from this study will provide guidance in monitoring patients' early functional recovery post-surgery and in better planning post-surgical rehabilitation.\n\nThe study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.", 'detailedDescription': 'The study will include patients aged 50-75 who have undergone total knee arthroplasty surgery due to knee osteoarthritis. Demographic information such as age, height, weight, and body mass index will be recorded. Pain will be assessed using a visual analog scale, and edema will be measured during hospitalization, at the 2nd and 6th-week follow-up visits. In addition to all the evaluations, functional status will be assessed at the 2nd and 6th-week follow-up visits using the 5-repetition sit-to-stand test, 10-meter walking test, and 2-minute walking tests, as well as knee function evaluated through the WOMAC and KOS-ADLS questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent total knee arthroplasty at Hacettepe University faculty of medicine', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 50 and 75 years.\n* Have undergone unilateral total knee arthroplasty surgery due to osteoarthritis.\n* Hemodynamically stable post-surgery.\n* Willing to participate in the study.\n\nExclusion Criteria:\n\n* Having any neurological or oncological issues.\n* Having undergone revision surgery.\n* Having a history of cardiovascular surgery.'}, 'identificationModule': {'nctId': 'NCT06096792', 'briefTitle': 'Muscle Recovery After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Invastigation of the Relationship Between Early Quadriceps Arthrogenic Muscle Inhibition and Functional Recovery After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'K-Bubble TKA'}}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Samanpazari', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Sibel Bozgeyik Bağdatlı, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sibel Bozgeyik', 'investigatorAffiliation': 'Hacettepe University'}}}}