Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06585267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validate final questionnaire', 'timeFrame': 'From first post-op visit to 12month follow-up', 'description': 'Validation of final questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TKR', 'Questionnaire'], 'conditions': ['Complete Questionnaires Following TKR Surgery']}, 'descriptionModule': {'briefSummary': "Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.", 'detailedDescription': 'Patients will complete the final developed questionnaire for quantitative analysis only (involves no administration of any medicinal products or medical devices) and is considered a low-risk project.\n\nPatients will also be asked to complete the already validated EQ-5D-5L and Oxford Knee Score questionnaires at the same time as the final developed questionnaire following their Total Knee Replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are due to undergo TKR surgery or have undergone TKR surgery in the last 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years of age or older.\n* Patients who have undergone Total Knee Replacement surgery with a metal implant for the treatment of end-stage knee arthritis in the last 3 months.\n* Patients who have only undergone one Total Knee Replacement surgery on the index knee.\n* Patients who, in the opinion of the Investigator, are able to understand this project and co-operate with the requirements of participation.\n* Patients who are able to give voluntary, written informed consent to participate in this project and from whom consent has been obtained.\n\nExclusion Criteria:\n\n* Patients, who in the opinion of the Investigator, exhibit evidence of any condition or co-morbidity that would compromise their participation in the project.\n* Patients who are unable to understand and communicate fluently in English.\n* Patients who have experienced a complication following Total Knee Replacement surgery requiring a further hospital admission or revision surgery to the index knee.'}, 'identificationModule': {'nctId': 'NCT06585267', 'acronym': 'SYNC01- P4', 'briefTitle': "Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis", 'organization': {'class': 'INDUSTRY', 'fullName': 'Invibio Ltd'}, 'officialTitle': "Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis Phase Four - Validation of Final Questionnaire This Phase is to Validate the Final Questionnaire in Terms of Reliability, Validity and Ability to Detect Change", 'orgStudyIdInfo': {'id': 'SYNC01- P4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main patient Group', 'description': 'Patients who have undergone Total Knee Replacement (TKR) Surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS7 4SA', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Chapel Allerton Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Professor Hemant Pandit', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leeds Teaching Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only collated validated findings will be shared no individual data will be'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invibio Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oxford University Innovation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}