Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-20 @ 9:45 PM
Study NCT ID:
NCT05459259
Status:
UNKNOWN
Last Update Posted:
2022-11-18
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy for Arthrofibrosis Following Knee Replacement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative interviews with Patients and Healthcare Professionals', 'timeFrame': '12 months', 'description': 'we will conduct qualitative interviews with patients to explore (i) the experiences, important outcomes and unmet needs of patients; and with health care professionals (HCPs) to understand (ii) their experiences, perceptions and context of managing arthrofibrosis and (iii) their opinions on the intervention components identified in a systematic review of the evidence.'}, {'measure': 'A Delphi survey with HCPs and patients to achieve consensus agreement on the most important components of an optimal intervention.', 'timeFrame': '6 months', 'description': 'We will conduct a modified Delphi exercise with a maximum of 4 rounds to agree consensus on (i) the essential components of the intervention and what are the important outcomes that should be collected for patients with arthrofibrosis .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee stiffness'], 'conditions': ['Arthroplasty Complications', 'Fibrosis', 'Knee Joint Contracture']}, 'referencesModule': {'references': [{'pmid': '41273943', 'type': 'DERIVED', 'citation': 'Moffatt F, Narayanasamy M, Smith B, Stock J, Sheehan K, Sackley C, Hall M. "My bloody leg" - The lived experience of arthrofibrosis after total knee arthroplasty. Physiotherapy. 2025 Oct 28;130:101862. doi: 10.1016/j.physio.2025.101862. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This research aims to develop an optimal physiotherapy intervention for people with arthrofibrosis (stiffness due to scar tissue) after total knee replacement (TKR). We will develop an optimal intervention by conducting:\n\n1. A review of the evidence to identify what components could be included in the intervention, how effective they are and what outcomes have been measured by the research.\n2. Interviews with patients with arthrofibrosis to understand the impact it has on their life and what outcomes are important to them and interviews with healthcare professionals (HCPs) to understand their experiences of treating patients with arthrofibrosis.\n3. A Delphi study with a larger group of HCPs and patients to reach a consensus on what the optimal intervention should include. This involves a series of anonymous voting on a range of items that have been generated by the group and the results of the evidence review.\n4. A workshop with patients, HCPs and health-care commissioners to finalise the intervention. During the workshop we will present our findings and work in small groups to agree the intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had problematic stiffness following knee arthroplasty and healthcare professionals who manage patients with those conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Patients:\n\n* adults (aged 18 and over) of any age who have undergone elective TKR with post- operative arthrofibrosis/stiffness who have undergone manipulation under anaesthetic (MUA) in the previous 24 months or are currently listed for a MUA.\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Patients with neurological or blood disorders\n\nFor HCP participants :\n\n* at least 5 years of experience working with joint arthroplasty including the management of patients with arthrofibrosis or 3 years in the case of orthopaedic surgeons.'}, 'identificationModule': {'nctId': 'NCT05459259', 'acronym': 'ReSTART', 'briefTitle': 'Physiotherapy for Arthrofibrosis Following Knee Replacement.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Development of an Optimal Physiotherapy Intervention for Arthrofibrosis Following Total Knee Replacement. ReSTART Study (Reducing Stiffness After Knee Replacement)', 'orgStudyIdInfo': {'id': '22027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients participants', 'description': 'Adults who have undergone elective knee arthroplasty with post-operative arthrofibrosis/stiffness who have undergone MUA in the previous 24 months or are currently listed for a MUA.', 'interventionNames': ['Other: Interviews and Delphi Survey']}, {'label': 'Healthcare Professionals', 'description': 'Physiotherapists/Occupational Therapist/ Nurses and Orthopedic surgeons with clinical experience in the management of patients with arthrofibrosis following knee joint arthroplasty', 'interventionNames': ['Other: Interviews and Delphi Survey']}], 'interventions': [{'name': 'Interviews and Delphi Survey', 'type': 'OTHER', 'description': 'no intervention delivered', 'armGroupLabels': ['Healthcare Professionals', 'Patients participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 UH', 'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michelle C Hall, PhD', 'role': 'CONTACT', 'email': 'michelle.hall@notitngham.ac.uk'}, {'name': 'Catherine Sackley, PhD', 'role': 'CONTACT', 'email': 'catherine.sackley@nottingham.ac.uk'}, {'name': 'Michelle Hall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Melanie Narayanasamy, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Michelle C Hall, PhD', 'role': 'CONTACT', 'email': 'michelle.hall@nottingham.ac.uk', 'phone': '0115 8231794'}], 'overallOfficials': [{'name': 'Michelle C Hall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}