Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05980793
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data analysts will be masked for treatment allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel group, two-arm, randomized, controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on load (change baseline to -12 months)', 'timeFrame': '0-12 months', 'description': 'Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Pain at rest (change baseline to -3, -6, -12 months)', 'timeFrame': '0-12 months', 'description': 'Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)'}, {'measure': 'HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months', 'timeFrame': '0-12 months', 'description': 'A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome.'}, {'measure': 'PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months', 'timeFrame': '0-12 months', 'description': 'A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)'}, {'measure': 'EQ5D-5L change baseline to -3, -6, -12 months', 'timeFrame': '0-12 months', 'description': 'A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).'}, {'measure': 'Objective function change baseline to -3, -6, -12 months', 'timeFrame': '0-12 months', 'description': 'Range of motion (goniometer with 5 degrees interval)'}, {'measure': 'Objective function change baseline to -3, -6, -12 months', 'timeFrame': '0-12 months', 'description': 'grip strength (hydraulic hand dynamometer, kilograms)'}, {'measure': 'Complications', 'timeFrame': '0-12 months', 'description': '2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)'}, {'measure': 'Complications', 'timeFrame': '0-12 months', 'description': 'Mini Sollerman (0-12 points, 12 indicating a better outcome)'}, {'measure': 'Complications', 'timeFrame': '0-12 months', 'description': 'Infection (clinical evaluation, positive cultures, need for antibiotics)'}, {'measure': 'Additional treatment', 'timeFrame': '0-12 months', 'description': 'Need for further surgery/treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis Finger', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '39169395', 'type': 'DERIVED', 'citation': 'Sward EM, Beckman J, Tabaroj F, Wilcke MK. Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial. Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are:\n\n* Are the treatments effective?\n* Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise).\n\nResearchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.', 'detailedDescription': 'This is a parallel group, two-arm, randomized, controlled trial comparing the effects of surgical denevation to patient education plus exercise in patients with symptomatic PIP joint osteoarthritis.\n\nThe research questions are:\n\n1. Does any of the treatments denervation of the PIP-joint and patient education plus exercise decrease pain, improve patient-reported outcomes, grip strength and range of motion (ROM) in PIP-joint osteoarthritis?\n2. Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes grip strength and ROM more effectively than patient education plus exercise for PIP-joint osteoarthritis?\n\nParticipants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint or education plus exercise. A block randomization scheme with a fixed block size of 10 will be used. Patients will be stratified according to gender. Sealed opaque envelopes will be used and data analysts will be masked for treatment allocation.\n\nAssesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary enpoint is 12 months after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Chronic symptomatic osteoarthritis in the PIP-joint.\n* Radiological signs of osteoarthritis on posteroanterior and lateral radiographs assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren \\& Lawrence, 1957).\n* Clinical signs of PIP-joint arthritis.\n\nExclusion Criteria:\n\n* Inflammatory arthritis.\n* Ongoing infection in the hand.\n* Inability to co-operate with the follow-up protocol.\n* Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected joint less than 3 months prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT05980793', 'briefTitle': 'Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DOPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'PIP joint denervation is performed through a volar approach.', 'interventionNames': ['Procedure: PIP joint denervation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-surgical treatment', 'description': 'An education and exercise program.', 'interventionNames': ['Procedure: Patient education plus exercise']}], 'interventions': [{'name': 'PIP joint denervation', 'type': 'PROCEDURE', 'description': 'Surgical denervation of the PIP joint', 'armGroupLabels': ['Surgical treatment']}, {'name': 'Patient education plus exercise', 'type': 'PROCEDURE', 'description': 'An education plus exercise program', 'armGroupLabels': ['Non-surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Elin Swärd, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Hand Surgery, Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Elin Sward, MD, PhD', 'role': 'CONTACT', 'email': 'elin.sward@regionstockholm.se', 'phone': '+46812361000'}], 'overallOfficials': [{'name': 'Elin Sward, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hand Surgery Sodersjukhuset and Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stockholm South General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Elin Swärd', 'investigatorAffiliation': 'Karolinska Institutet'}}}}