Skip to main content
OpenTrials
Completed

NCT Number: NCT03558204

Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thumb Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denervation of the thumb CMC joint

Procedure

Removal/disconnection of the nerve branches to the joint from their attachments to the joint

trapeziectomy with ligament reconstruction (LRTI)

Procedure

excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon

Primary outcomes

  1. Change in Hand Function

    Time frame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6, months, 12 months, and 2 years.

    brief Michigan Hand Questionnaire (MHQ). (score ranges from 0 to 100, lower score indicates better function)

  2. Change in grip and lateral pinch strength

    Time frame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.

    position 2 on dynamometer (grip) and pinch meter (both are measured in kg of force, higher value indicates more strength)

  3. Change in pain level

    Time frame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.

    Likert scale (score ranges from 0-10, lower score indicates less pain)

  4. narcotic pain medication usage

    Time frame: Up to 3 months.

    number of oxycodone 5 mg tablets (or equivalent) used after surgery (lower value indicates fewer narcotic tablets used)

Secondary outcomes

  1. Time to release to unrestricted activity

    Time frame: Up to 6 months.

    Number of days between surgery day and when patient is released to unrestricted activity (lower value indicates fewer days between day of surgery and when the patient was released to unrestricted activity).

  2. Operative duration

    Time frame: Up to 1 day

    Tourniquet time and surgery start to surgery end time (both measured in minutes, lower values indicate the surgery took less time to complete)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Surgical Management of Thumb Carpometacarpal Arthritis With Selective Joint Denervation Versus Trapeziectomy

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2018
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.