Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Procedure: Denervation of the thumb CMC joint
* Procedure: trapeziectomy with ligament reconstruction (LRTI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CMC denervation<br>Patients will undergo denervation of the thumb CMC joint | Procedure: Denervation of the thumb CMC joint<br>* Removal/disconnection of the nerve branches to the joint from their attachments to the joint<br>|
| trapeziectomy with ligament reconstruction (LRTI)<br>Patients will undergo excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon | Procedure: trapeziectomy with ligament reconstruction (LRTI)<br>* excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hand Function | brief Michigan Hand Questionnaire (MHQ). (score ranges from 0 to 100, lower score indicates better function) | Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6, months, 12 months, and 2 years. | 
| Change in grip and lateral pinch strength | position 2 on dynamometer (grip) and pinch meter (both are measured in kg of force, higher value indicates more strength) | Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years. | 
| Change in pain level | Likert scale (score ranges from 0-10, lower score indicates less pain) | Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years. | 
| narcotic pain medication usage | number of oxycodone 5 mg tablets (or equivalent) used after surgery (lower value indicates fewer narcotic tablets used) | Up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to release to unrestricted activity | 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). | Up to 6 months. | 
| Operative duration | Tourniquet time and surgery start to surgery end time (both measured in minutes, lower values indicate the surgery took less time to complete) | Up to 1 day |