Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-26 @ 8:03 PM
Study NCT ID:
NCT05644132
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-18', 'releaseDate': '2025-06-04'}], 'estimatedResultsFirstSubmitDate': '2025-06-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Survival', 'timeFrame': 'Post-op 1 month', 'description': 'Device surviving in service where survival is a lack of a device failure.'}, {'measure': 'Device Survival', 'timeFrame': 'Post-op 2 month', 'description': 'Device surviving in service where survival is a lack of a device failure.'}, {'measure': 'Device Survival', 'timeFrame': 'Post-op 3 month', 'description': 'Device surviving in service where survival is a lack of a device failure.'}, {'measure': 'Device Survival', 'timeFrame': 'Post-op 6 month', 'description': 'Device surviving in service where survival is a lack of a device failure.'}, {'measure': 'Device Survival', 'timeFrame': 'Post-op 12 month', 'description': 'Device surviving in service where survival is a lack of a device failure.'}, {'measure': 'DASH Scores (Scale: 0-100)', 'timeFrame': 'Post-op 3 months', 'description': 'Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.'}, {'measure': 'DASH Scores (Scale: 0-100)', 'timeFrame': 'Post-op 6 months', 'description': 'Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.'}, {'measure': 'DASH Scores (Scale: 0-100)', 'timeFrame': 'Post-op 12 months', 'description': 'Disability of Arm, Shoulder and Hand (DASH) questionnaire to assess upper extremity disability and symptoms. Lower scores indicate better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) Pain Score', 'timeFrame': 'Post-op 2 months', 'description': 'Subjective measure to assess pain. Lower scores indicate better outcomes.'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score', 'timeFrame': 'Post-op 3 months', 'description': 'Subjective measure to assess pain. Lower scores indicate better outcomes.'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score', 'timeFrame': 'Post-op 6 months', 'description': 'Subjective measure to assess pain. Lower scores indicate better outcomes.'}, {'measure': 'Visual Analogue Scale (VAS) Pain Score', 'timeFrame': 'Post-op 12 months', 'description': 'Subjective measure to assess pain. Lower scores indicate better outcomes.'}, {'measure': 'Grip and pinch strength measurements', 'timeFrame': 'Post-op 2 months', 'description': 'Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.'}, {'measure': 'Grip and pinch strength measurements', 'timeFrame': 'Post-op 3 months', 'description': 'Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.'}, {'measure': 'Grip and pinch strength measurements', 'timeFrame': 'Post-op 6 months', 'description': 'Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.'}, {'measure': 'Grip and pinch strength measurements', 'timeFrame': 'Post-op 12 months', 'description': 'Assessment of Grip, Tip Pinch, and Lateral Pinch strength. Higher scores indicate better outcomes.'}, {'measure': 'Kapandji Score', 'timeFrame': 'Post-op 2 months', 'description': 'Assessment of Range of Motion. Higher scores indicate better outcomes.'}, {'measure': 'Kapandji Score', 'timeFrame': 'Post-op 3 months', 'description': 'Assessment of Range of Motion. Higher scores indicate better outcomes.'}, {'measure': 'Kapandji Score', 'timeFrame': 'Post-op 6 months', 'description': 'Assessment of Range of Motion. Higher scores indicate better outcomes.'}, {'measure': 'Kapandji Score', 'timeFrame': 'Post-op 12 months', 'description': 'Assessment of Range of Motion. Higher scores indicate better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thumb carpometacarpal joint (CMCJ) arthritis', 'InDx Implant System'], 'conditions': ['Osteoarthritis Thumb Base Joint']}, 'referencesModule': {'references': [{'pmid': '28666676', 'type': 'BACKGROUND', 'citation': 'Cootjans K, Vanhaecke J, Dezillie M, Barth J, Pottel H, Stockmans F. Joint Survival Analysis and Clinical Outcome of Total Joint Arthroplasties With the ARPE Implant in the Treatment of Trapeziometacarpal Osteoarthritis With a Minimal Follow-Up of 5 Years. J Hand Surg Am. 2017 Aug;42(8):630-638. doi: 10.1016/j.jhsa.2017.05.007. Epub 2017 Jun 28.'}, {'pmid': '29117844', 'type': 'BACKGROUND', 'citation': 'Craik JD, Glasgow S, Andren J, Sims M, Mansouri R, Sharma R, Ellahee N. Early Results of the ARPE Arthroplasty Versus Trapeziectomy for the Treatment of Thumb Carpometacarpal Joint Osteoarthritis. J Hand Surg Asian Pac Vol. 2017 Dec;22(4):472-478. doi: 10.1142/S0218810417500526.'}, {'pmid': '25542440', 'type': 'BACKGROUND', 'citation': 'Crisco JJ, Halilaj E, Moore DC, Patel T, Weiss AP, Ladd AL. In Vivo kinematics of the trapeziometacarpal joint during thumb extension-flexion and abduction-adduction. J Hand Surg Am. 2015 Feb;40(2):289-96. doi: 10.1016/j.jhsa.2014.10.062. Epub 2014 Dec 24.'}, {'pmid': '15374852', 'type': 'BACKGROUND', 'citation': 'Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.'}, {'pmid': '23409567', 'type': 'BACKGROUND', 'citation': 'Eecken SV, Vanhove W, Hollevoet N. Trapeziometacarpal joint replacement with the Arpe prosthesis. Acta Orthop Belg. 2012 Dec;78(6):724-9.'}, {'pmid': '18675718', 'type': 'BACKGROUND', 'citation': 'Fitzgerald BT, Hofmeister EP. Treatment of advanced carpometacarpal joint disease: trapeziectomy and hematoma arthroplasty. Hand Clin. 2008 Aug;24(3):271-6, vi. doi: 10.1016/j.hcl.2008.03.003.'}, {'pmid': '34003322', 'type': 'BACKGROUND', 'citation': 'Borgers A, Verstreken A, Vanhees M, Verstreken F. Primary endoprosthetic replacement of the arthritic CMC-1 joint. Oper Orthop Traumatol. 2021 Jun;33(3):228-244. doi: 10.1007/s00064-021-00713-y. Epub 2021 May 18.'}, {'pmid': '35638603', 'type': 'BACKGROUND', 'citation': 'Duerinckx J, Verstreken F. Total joint replacement for osteoarthritis of the carpometacarpal joint of the thumb: why and how? EFORT Open Rev. 2022 May 31;7(6):349-355. doi: 10.1530/EOR-22-0027.'}, {'pmid': '38202128', 'type': 'BACKGROUND', 'citation': 'Farkash U, Sakhnini M, Dreyfuss D, Tordjman D, Rotem G, Luria S. Failure Rate and Early Complications of Thumb Carpometacarpal Joint Replacement-A Multicenter Retrospective Study of Two Modern Implant Designs. J Clin Med. 2023 Dec 25;13(1):121. doi: 10.3390/jcm13010121.'}, {'pmid': '34575201', 'type': 'BACKGROUND', 'citation': 'Froschauer SM, Holzbauer M, Mihalic JA, Kwasny O. TOUCH(R) Prosthesis for Thumb Carpometacarpal Joint Osteoarthritis: A Prospective Case Series. J Clin Med. 2021 Sep 10;10(18):4090. doi: 10.3390/jcm10184090.'}, {'pmid': '16651933', 'type': 'BACKGROUND', 'citation': 'Ghavami A, Oishi SN. Thumb trapeziometacarpal arthritis: treatment with ligament reconstruction tendon interposition arthroplasty. Plast Reconstr Surg. 2006 May;117(6):116e-128e. doi: 10.1097/01.prs.0000214652.31293.23.'}, {'pmid': '18991176', 'type': 'BACKGROUND', 'citation': 'Hansen TB, Snerum L. Elektra trapeziometacarpal prosthesis for treatment of osteoarthrosis of the basal joint of the thumb. Scand J Plast Reconstr Surg Hand Surg. 2008;42(6):316-9. doi: 10.1080/02844310802393974.'}, {'pmid': '21622766', 'type': 'BACKGROUND', 'citation': 'Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.'}, {'pmid': '21768213', 'type': 'BACKGROUND', 'citation': 'Hernandez-Cortes P, Pajares-Lopez M, Robles-Molina MJ, Gomez-Sanchez R, Toledo-Romero MA, De Torres-Urrea J. Two-year outcomes of Elektra prosthesis for trapeziometacarpal osteoarthritis: a longitudinal cohort study. J Hand Surg Eur Vol. 2012 Feb;37(2):130-7. doi: 10.1177/1753193411414505. Epub 2011 Jul 18.'}, {'pmid': '8773720', 'type': 'BACKGROUND', 'citation': 'Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.'}, {'pmid': '19683881', 'type': 'BACKGROUND', 'citation': 'Jorheim M, Isaxon I, Flondell M, Kalen P, Atroshi I. Short-term outcomes of trapeziometacarpal artelon implant compared with tendon suspension interposition arthroplasty for osteoarthritis: a matched cohort study. J Hand Surg Am. 2009 Oct;34(8):1381-7. doi: 10.1016/j.jhsa.2009.04.016. Epub 2009 Aug 15.'}, {'pmid': '3963909', 'type': 'BACKGROUND', 'citation': 'Kapandji A. [Clinical test of apposition and counter-apposition of the thumb]. Ann Chir Main. 1986;5(1):67-73. doi: 10.1016/s0753-9053(86)80053-9. French.'}, {'pmid': '22491000', 'type': 'BACKGROUND', 'citation': 'Klahn A, Nygaard M, Gvozdenovic R, Boeckstyns ME. Elektra prosthesis for trapeziometacarpal osteoarthritis: a follow-up of 39 consecutive cases. J Hand Surg Eur Vol. 2012 Sep;37(7):605-9. doi: 10.1177/1753193412443501. Epub 2012 Apr 4.'}, {'pmid': '34244850', 'type': 'BACKGROUND', 'citation': 'Raj S, Clay R, Ramji S, Shaunak R, Dadrewalla A, Sinha V, Shaunak S. Trapeziectomy versus joint replacement for first carpometacarpal (CMC 1) joint osteoarthritis: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol. 2022 Aug;32(6):1001-1021. doi: 10.1007/s00590-021-03070-5. Epub 2021 Jul 9.'}, {'pmid': '12015732', 'type': 'BACKGROUND', 'citation': 'SooHoo NF, McDonald AP, Seiler JG 3rd, McGillivary GR. Evaluation of the construct validity of the DASH questionnaire by correlation to the SF-36. J Hand Surg Am. 2002 May;27(3):537-41. doi: 10.1053/jhsu.2002.32964.'}, {'pmid': '24880607', 'type': 'BACKGROUND', 'citation': 'Taleb C, Berner S, Mantovani Ruggiero G. First metacarpal resurfacing with polyvinyl alcohol implant in osteoarthritis: preliminary study. Chir Main. 2014 Jun;33(3):189-95. doi: 10.1016/j.main.2014.03.001. Epub 2014 Mar 20.'}, {'pmid': '20185250', 'type': 'BACKGROUND', 'citation': 'van Rijn J, Gosens T. A cemented surface replacement prosthesis in the basal thumb joint. J Hand Surg Am. 2010 Apr;35(4):572-9. doi: 10.1016/j.jhsa.2009.12.026. Epub 2010 Feb 24.'}, {'pmid': '32257609', 'type': 'BACKGROUND', 'citation': 'Berkhout MJ, Yin Q, Ritt MJPF. Current Trends in Operative Treatment of Scaphotrapeziotrapezoid Osteoarthritis: A Survey among European Hand Surgeons. J Wrist Surg. 2020 Apr;9(2):94-99. doi: 10.1055/s-0039-3402796. Epub 2020 Feb 12.'}, {'pmid': '12687546', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Xu L, Nevitt MC, Niu J, Goggins JP, Aliabadi P, Yu W, Lui LY, Felson DT. Lower prevalence of hand osteoarthritis among Chinese subjects in Beijing compared with white subjects in the United States: the Beijing Osteoarthritis Study. Arthritis Rheum. 2003 Apr;48(4):1034-40. doi: 10.1002/art.10928.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to evaluate the safety and effectiveness of the lnDx Implant in the treatment of thumb base joint arthritis.\n\nThis clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.\n\nParticipants will undergo the following measures to assess their clinical performance:\n\n* Hand X-Ray\n* Range of Motion - Kapandji opposition score\n* Grip strength, lateral pinch and tip pinch\n* Visual Analogue Scale (VAS) for Pain\n* Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is at least 18 years of age;\n* The patient has a confirmed Grade 1-111 osteoarthritis of the CMG joint on clinical examination and X-ray;\n* The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;\n* The patient is able to understand the aims and objectives of the trial and is willing to consent;\n* Be willing and able to return for all study-related follow-up procedures;\n* If female, is either using contraception or is postmenopausal, or male partner is using contraception; and\n* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the institutional review board/ethics committee.\n\nExclusion Criteria:\n\n* The patient is \\<18 years of age;\n* The patient is suffering from Rheumatoid Arthritis;\n* The patient is suffering from Grade IV osteoarthritis of the CMG joint;\n* The patient is suffering post-traumatic arthritis of the CMG joint;\n* The patient is a pregnant/lactating female (tested as per institutional requirements);\n* Active or latent infection, or sepsis;\n* Insufficient quantity or quality of bone and/or soft tissue;\n* Metal or polymer material sensitivity;\n* Patients who are unwilling or incapable of following postoperative care instructions or protocol requirements;\n* Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;\n* Patient with previous thumb surgery;\n* In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to, subjects with a diagnosis of concomitant injury that may interfere with healing; subjects with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult; subjects who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents;\n* Comorbidity that reduces life expectancy to less than 36 months.'}, 'identificationModule': {'nctId': 'NCT05644132', 'acronym': 'THANKS', 'briefTitle': 'Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Loci Orthopaedics'}, 'officialTitle': 'Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial', 'orgStudyIdInfo': {'id': 'lnDx01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thumb base joint prosthesis', 'interventionNames': ['Device: InDx Implant for the carpometacarpal joint']}], 'interventions': [{'name': 'InDx Implant for the carpometacarpal joint', 'type': 'DEVICE', 'description': 'Treatment of thumb base joint arthritis with the InDx Implant', 'armGroupLabels': ['Thumb base joint prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loci Orthopaedics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'North American Science Associates Ltd.', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-04', 'type': 'RELEASE'}, {'date': '2025-06-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Loci Orthopaedics'}}}}