Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy
NCT ID: NCT03558204
Last Updated: 2023-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2018-08-01
2023-01-30
Brief Summary
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Detailed Description
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Pre-operative and peri-operative care will be unchanged from standard patient care. Both procedures are outpatient procedures, usually performed under regional anesthesia and patients go home the same day. Patients are discharged with a standard thumb spica splint which is removed on their first clinic appointment which is generally post-operative day 7.
Patients enrolled in the study will have additional follow up at the 3, 6, 12 and 24 month time points. At the 3, 6, 12 and 24 month time points patients will be asked to come to clinic for evaluation with 1) a standard hand questionnaire the Michigan Hand Questionnaire, 2) lateral pinch strength, grip strength and range of motion testing, 3) Kapandji score, 4) visual analog pain scale. Each visit will take approximately 15 minutes. Patients who are unable to follow up in clinic will be given a phone questionnaire with the Michigan Hand Questionnaire, visual analog pain scale and opiate usage. There is no monetary compensation for participation in the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CMC denervation
Patients will undergo denervation of the thumb CMC joint
Denervation of the thumb CMC joint
Removal/disconnection of the nerve branches to the joint from their attachments to the joint
trapeziectomy with ligament reconstruction (LRTI)
Patients will undergo excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon
trapeziectomy with ligament reconstruction (LRTI)
excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon
Interventions
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Denervation of the thumb CMC joint
Removal/disconnection of the nerve branches to the joint from their attachments to the joint
trapeziectomy with ligament reconstruction (LRTI)
excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Scott D Lifchez, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Countries
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References
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Haase SC, Chung KC. An evidence-based approach to treating thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2011 Feb;127(2):918-925. doi: 10.1097/PRS.0b013e3182046901.
Aliu O, Davis MM, DeMonner S, Chung KC. The influence of evidence in the surgical treatment of thumb basilar joint arthritis. Plast Reconstr Surg. 2013 Apr;131(4):816-828. doi: 10.1097/PRS.0b013e3182818d08.
Giesen T, Klein HJ, Franchi A, Medina JA, Elliot D. Thumb carpometacarpal joint denervation for primary osteoarthritis: A prospective study of 31 thumbs. Hand Surg Rehabil. 2017 Jun;36(3):192-197. doi: 10.1016/j.hansur.2017.01.007. Epub 2017 Apr 25.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Leamy DJ, Kocijan J, Domijan K, Duffin J, Roche RA, Commins S, Collins R, Ward TE. An exploration of EEG features during recovery following stroke - implications for BCI-mediated neurorehabilitation therapy. J Neuroeng Rehabil. 2014 Jan 28;11:9. doi: 10.1186/1743-0003-11-9.
Chung KC, Hamill JB, Walters MR, Hayward RA. The Michigan Hand Outcomes Questionnaire (MHQ): assessment of responsiveness to clinical change. Ann Plast Surg. 1999 Jun;42(6):619-22. doi: 10.1097/00000637-199906000-00006.
Wolf JM, Delaronde S. Current trends in nonoperative and operative treatment of trapeziometacarpal osteoarthritis: a survey of US hand surgeons. J Hand Surg Am. 2012 Jan;37(1):77-82. doi: 10.1016/j.jhsa.2011.10.010. Epub 2011 Nov 25.
Yuan F, Aliu O, Chung KC, Mahmoudi E. Evidence-Based Practice in the Surgical Treatment of Thumb Carpometacarpal Joint Arthritis. J Hand Surg Am. 2017 Feb;42(2):104-112.e1. doi: 10.1016/j.jhsa.2016.11.029.
Waljee JF, Chung KC. Outcomes research in rheumatoid arthritis. Hand Clin. 2011 Feb;27(1):115-26. doi: 10.1016/j.hcl.2010.10.005.
Other Identifiers
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IRB00154490
Identifier Type: -
Identifier Source: org_study_id
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