Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT04458961
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding of participants and trial personnel will not be possible due to the nature of the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of recruitment of participants', 'timeFrame': '20 months', 'description': 'Number of recruits compared to the number of potential participants.'}], 'secondaryOutcomes': [{'measure': 'Explaining the study', 'timeFrame': '20 months', 'description': 'Assessment of the process of explaining the study (explanation/recruitment/randomisation) between patients and surgeons via qualitative analysis of audio recording of pre-operative discussions about entering the study.'}, {'measure': 'Reasons for non-participation', 'timeFrame': '20 months', 'description': 'Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.'}, {'measure': 'Patient experience', 'timeFrame': '2 weeks after surgery', 'description': 'Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.'}, {'measure': 'Surgeon experience', 'timeFrame': '20 months', 'description': 'Experience of the process of recruitment, randomisation and study participation including thoughts about trial design via qualitative analysis of semi-structured interview after each patient surgery and at the end of the trial.'}, {'measure': 'Protocol adherence', 'timeFrame': '20 months', 'description': 'Assessment of any deviations or violations to protocol that occur during the trial.'}, {'measure': 'Healthcare resource utilisation', 'timeFrame': '20 months', 'description': 'Patient-reported questionnaire assessing heath and social resource use through an adapted questionnaire of the Client Service Receipt Inventory (CSRI) at 3 and 6 months post-operatively'}, {'measure': 'Comparison of two sites', 'timeFrame': '20 months', 'description': 'Recruitment and attrition rates at the two sites'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates', 'timeFrame': '20 months', 'description': 'Patient-reported questionnaire assessing short-term and long-term symptoms and function in patients with knee injury to be administered pre-, 3 months and 6 months post-operatively'}, {'measure': 'Oxford Knee Score (OKS) outcome and completion rates', 'timeFrame': '20 months', 'description': 'Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively'}, {'measure': 'EQ-5D-5L outcome and completion rates', 'timeFrame': '20 months', 'description': 'Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthropathy', 'Arthropathy Related to Infection', 'Arthropathy of Knee Joint', 'One-stage', 'Two-stage', 'Infection', 'Prosthetic joint infection'], 'conditions': ['Arthroplasty, Replacement, Knee']}, 'referencesModule': {'references': [{'pmid': '40241215', 'type': 'DERIVED', 'citation': 'Terry R, Dean S, Hourigan P, Waterson HB, Wylde V, Carpenter N, Whale B, Powell RJ, Tarrant P, Medina-Lara A, Alvand A, Toms AD. MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection. Pilot Feasibility Stud. 2025 Apr 16;11(1):49. doi: 10.1186/s40814-025-01634-4.'}]}, 'descriptionModule': {'briefSummary': "Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery\n* Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery.\n* Case meets the International Consensus Meeting criteria for infection\n* Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable\n\nExclusion Criteria:\n\n* Unable or unwilling to undergo either treatment\n* Lacking capacity to consent to research\n* Refusal to consent to study for any reason\n* Re-revision of prosthetic knee infection if first revision was for infection\n* Presence of tuberculosis infection'}, 'identificationModule': {'nctId': 'NCT04458961', 'acronym': 'MIKROBE', 'briefTitle': 'MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence A Feasibility Study for a Randomised Controlled Trial of One-stage or Two-stage Surgery for Prosthetic Knee Infection', 'orgStudyIdInfo': {'id': '272334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One-stage', 'interventionNames': ['Procedure: One-stage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two-stage', 'interventionNames': ['Procedure: Two-stage']}], 'interventions': [{'name': 'One-stage', 'type': 'PROCEDURE', 'description': 'A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.', 'armGroupLabels': ['One-stage']}, {'name': 'Two-stage', 'type': 'PROCEDURE', 'description': 'A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.', 'armGroupLabels': ['Two-stage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT)', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Nuffiels Orthopaedic Centre (NOC)', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Andrew Toms, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Devon and Exeter NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Exeter', 'class': 'OTHER'}, {'name': 'Nuffield Orthopaedic Centre NHS Trust', 'class': 'OTHER'}, {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Wrightington, Wigan and Leigh NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}