Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2025-12-29 @ 12:13 PM
Study NCT ID:
NCT06644092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS', 'timeFrame': '6 months', 'description': "Knee Injury and Osteoarthritis Outcome Score (KOOS): A health measure used to evaluate knee injuries and knee-related conditions such as osteoarthritis. The KOOS comes in a widely used questionnaire format to assess patients' knee function, pain, quality of life, and other symptoms. By measuring problems in subcategories such as pain, symptoms, quality of life, functional limitations, and sports/dialysis activities, it provides healthcare professionals with an important tool to monitor patients' response to treatment, evaluate treatment plans, and understand patients' quality of life."}, {'measure': 'Oxford Knee Scale', 'timeFrame': '6 months', 'description': 'The Oxford Knee Score (ODS) is a valid and reliable questionnaire with a Turkish version that allows individuals with knee OA to assess their own function and pain. It is scored on a Likert scale from 0 (absent) to 4 (severe) (0-48). In this questionnaire consisting of 12 questions, questions 2, 3, 7, 11 and 12 assess functional status; questions 1, 4, 5, 6, 8, 9 and 10 assess pain-related status. Scores from ODS pain questions range from 0 to 28 points, with the lowest score being 0 and the highest score being 28. Scores from ODS function 30 parameters range from 0 to 20 points, with the lowest score being 0 and the highest score being 20. High scores indicate worse functional status and pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Therapy', 'Osteochondral Allograft Transplantation', 'Osteochondral Lesion', 'Cartilage Damage'], 'conditions': ['Cartilage Damage', 'Osteochondral Lesion', 'Allograft', 'Osteoarthritis of Knee']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "1. Nho SJ, Pensak MJ, Seigerman DA, Cole BJ. Rehabilitation after autologous chondrocyte implantation in athletes. Clinics in sports medicine. 2010 Apr 1;29(2):267-82. 2. Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct 1;42(10):1795-801. 3. Moyad TF. Cartilage injuries in the adult knee: evaluation and management. Cartilage. 2011 Jul;2(3):226-36. 4. Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2002 Sep 1;18(7):730-4. 5. Chimutengwende-Gordon M, Donaldson J, Bentley G. Current solutions for the treatment of chronic articular cartilage defects in the knee. EFORT open reviews. 2020 Mar 2;5(3):156-63. 6. Berta Á, Duska Z, Tóth F, Hangody L. Clinical experiences with cartilage repair techniques: outcomes, indications, contraindications and rehabilitation. Joint Diseases and Related Surgery. 2015;26(2):084-96. 7. Cole BJ, Haunschild ED, Carter T, Meyer J, Fortier LA, Gilat R, ... & Pace JL. Clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture augmentation using cartilage allograft extracellular matrix: a multicenter prospective study. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2021 May;37(5):1512-1521. 8. Vogt S, Angele P, Arnold M, Brehme K, Cotic M, Haasper C, Hinterwimmer S, Imhoff AB, Petersen W, Salzmann G, Steinwachs M. Practice in rehabilitation after cartilage therapy: an expert survey. Archives of orthopaedic and trauma surgery. 2013 Mar;133:311-20. 9. Krych AJ, Saris DB, Stuart MJ, Hacken B. Cartilage injury in the knee: assessment and treatment options. JAAOS-Journal of the American Academy of Orthopaedic Surgeons. 2020 Nov;28(22):914-922. 10. Crowley SG, Pedersen A, Fortney TA, Swindell HW, Saltzman BM, Popkin CA, Trofa DP. Rehabilitation variability fo"}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to add to the literature the effect of the effectiveness of the physiotherapy and rehabilitation in the clinic, which will be applied to the patients after the osteochondral allograft transplantation operation, which is a current treatment approach applied after knee cartilage tissue damage, on the range of motion, functionality, pain and muscle strength of the patients during the recovery process. The clinical importance of our aim is that it will have the potential to guide health professionals in determining the appropriate treatment approach in order to reveal the best results that can be obtained due to the lack of many studies in the literature on the treatment of patients after osteochondral allograft surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nPatients who underwent osteochondral allograft transplantation surgery Participant's acceptance/desire to participate in the study\n\nExclusion criteria:\n\nPatient participant's refusal/desire to participate in the study Inability to perform exercises due to infection etc."}, 'identificationModule': {'nctId': 'NCT06644092', 'briefTitle': 'Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation', 'orgStudyIdInfo': {'id': 'YagmurOrta'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft', 'description': "The question of our research is to determine the effectiveness of the physiotherapy and rehabilitation protocol applied in the postoperative period on the knee joint range of motion, functionality, muscle strength around the knee joint (quadriceps/hamstring ratio) and pain parameters in patients who underwent osteochondral allograft transplantation surgery and to include it in the literature. In this direction, the hypotheses of our study are; H0: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery has a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain.\n\nH1: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery does not have a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain.", 'interventionNames': ['Other: Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation']}], 'interventions': [{'name': 'Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation', 'type': 'OTHER', 'description': 'The treatment protocol to be applied to the patients after surgery was determined. The protocol includes; cold application, game ready device application, CPM device application, patellar mobilization, soft tissue mobilization application, TENS, conventional TENS and NMES application, ultrasound application, stretching exercises, strengthening exercises, mobilization exercises, balance and proprioception exercises, walking training and kinesio taping.', 'armGroupLabels': ['Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Atasehir', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yeditepe University', 'investigatorFullName': 'YagmurOrta', 'investigatorAffiliation': 'Yeditepe University'}}}}