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Clinical Trial Summary

This is a prospective study tracking the outcomes of patients who undergo either of two treatments for thumb carpo-metacarpal joint arthritis: trapeziectomy with ligament reconstruction (LRTI) or denervation.


Clinical Trial Description

A total of 100 patients with carpo-metacarpal (CMC) arthritis will be enrolled in the study. The design of the study is a prospective non-blinded, non-randomized control study. Enrollment will occur at the time of initial clinic visit. All patients presenting with CMC arthritis and deemed appropriate for surgery will be considered for screened for inclusion. As a part of routine workup for CMC arthritis patients receive a hand xray. Specific attendings will perform their preferred technique for CMC arthritis: two perform denervation of the CMC joint, and two perform trapeziectomy with ligament reconstruction tendon-interposition (LRTI) only per their normal clinical practice. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03558204
Study type Observational
Source Johns Hopkins University
Contact
Status Completed
Phase
Start date August 1, 2018
Completion date January 30, 2023

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