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Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy

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Johns Hopkins University

Status

Completed

Conditions

Thumb Osteoarthritis

Treatments

Procedure: Denervation of the thumb CMC joint
Procedure: trapeziectomy with ligament reconstruction (LRTI)

Study type

Observational

Funder types

Other

Identifiers

NCT03558204
IRB00154490

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult men and women (>18 years of age) No prior traumatic thumb injuries (fractures, dislocation) No concurrent thumb procedures scheduled Eaton/Littler stage 2-4 osteoarthritis9 Minimal CMC joint subluxation on x-ray

Exclusion criteria

  • Traumatic thumb injury (fracture, dislocation) Prior thumb surgery proximal to the interphalangeal joint. Non-fluent English Speaking Planned concurrent procedures on the thumb eg ganglion removal, trigger thumb release

Trial design

53 participants in 2 patient groups

CMC denervation
Description:
Patients will undergo denervation of the thumb CMC joint
Treatment:
Procedure: Denervation of the thumb CMC joint
trapeziectomy with ligament reconstruction (LRTI)
Description:
Patients will undergo excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon
Treatment:
Procedure: trapeziectomy with ligament reconstruction (LRTI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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