Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:52 PM
Study NCT ID:
NCT07491302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pain improvement: VAS score', 'timeFrame': '3, 6, 9 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Functional improvement: Michigan Hand Questionnaire (MHQ-DLV)', 'timeFrame': '3, 6, 9 and 12 months'}, {'measure': 'Functional improvement: Grip and pinch test', 'timeFrame': '3, 6, 9 and 12 months'}, {'measure': 'Functional improvement: Opposition of the thumb (pollexograph)', 'timeFrame': '3, 6, 9 and 12 months'}, {'measure': 'Functional improvement: Kapandji score', 'timeFrame': '3, 6, 9 and 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet-rich plasma', 'CMC-I joint', 'carpometacarpal joint osteoarthritis', 'Thumb base osteoarthritis', 'PRP injection', 'Placebo-controlled trial', 'Orthobiologics', 'Regenerative medicine', 'Ultrasound-guided injection'], 'conditions': ['Thumb Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).\n\nThe main questions it aims to answer are:\n\nDoes a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?\n\nResearchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.\n\nParticipants will:\n\nReceive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.\n\nAttend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.\n\nUndergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Patients with an Eaton-littler score of I, II or III\n* Patients with uni- or bilateral CMC-I osteoarthritis\n* Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months\n\nExclusion Criteria:\n\n* Aged below 18\n* Patients with an Eaton-littler score of IV (STT arthrosis)\n* Surgical interventions of the CMC-I joint\n* A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus\n* Patients with an infectious arthritis of CMC-I joint\n* A known psychiatric condition\n* Neuropathic chronic pain syndrome\n* Intra articular injection 6 months prior to inclusion\n* Smoking\n* Active use of statins'}, 'identificationModule': {'nctId': 'NCT07491302', 'acronym': 'Thumbs-up', 'briefTitle': 'Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection', 'organization': {'class': 'OTHER', 'fullName': 'Goed Medisch Centrum'}, 'officialTitle': 'Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)', 'orgStudyIdInfo': {'id': 'NL-010929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-rich plasma group A', 'interventionNames': ['Biological: Platelet-Rich Plasma (PRP) Injections']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group B', 'description': 'Saline', 'interventionNames': ['Drug: Saline (0.9% NaCl)']}], 'interventions': [{'name': 'Platelet-Rich Plasma (PRP) Injections', 'type': 'BIOLOGICAL', 'description': "Autologous platelet-rich plasma (PRP) is prepared from 90 mL of the participant's venous blood using a standardized two-step centrifugation protocol (ACP® Max system, Arthrex Inc.). The first centrifugation is performed at 3200 rpm for 9 minutes, followed by a second centrifugation at 1500 rpm for 5 minutes, resulting in approximately 2 mL of PRP. A single injection of 2 mL PRP is administered under sterile conditions and ultrasound guidance into the CMC-I joint, consisting of 1 mL intra-articular and 1 mL peri-articular injection. No repeated injections are performed.", 'armGroupLabels': ['Platelet-rich plasma group A']}, {'name': 'Saline (0.9% NaCl)', 'type': 'DRUG', 'otherNames': ['Placebo injection'], 'description': 'Participants receive a placebo injection consisting of 2 mL sterile saline (0.9% NaCl), administered under sterile conditions and ultrasound guidance into the CMC-I joint. The injection protocol is identical to the PRP group, with 1 mL injected intra-articularly and 1 mL peri-articularly. To maintain blinding, participants in the placebo group undergo a venous blood draw mimicking the PRP preparation procedure; however, the collected blood is discarded. The duration and procedural steps are standardized to ensure comparable treatment conditions between groups. No repeated injections are performed.', 'armGroupLabels': ['Placebo group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goed Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthrex, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Evi Loos', 'investigatorAffiliation': 'Goed Medisch Centrum'}}}}