Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation

June 14, 2024 updated by: University of Calgary

Background: The thumb (or first) carpometacarpal (CMC) joint is commonly affected by osteoarthritis. Literature has reported a prevalence of 15% in women and 7% in men. First CMC joint osteoarthritis can present with decreased grip strength, pain, instability and inability to engage in routine daily activities. Definitive management is with surgery, however these are associated with known risks and increased weight times for the patient. First CMC joint denervation surgery is supported in the literature as a safe and effective approach to treat pain, strength, and thumb opposition which still allows for definitive surgery to be performed later if the arthritis progressed or if the pain returned later after the surgery.

Objectives: (1) evaluate the effectiveness of the neurectomy in patients with with CMC arthritis with respect to pain relief, functional parameters, and Quick disabilities of the arm, shoulder and hand (QuickDASH) scores; (2) to determine whether pain relief with selective nerve blocks are predictive of the outcome of the combined neurectomy; and (3) to determine whether improvement in grip strength following selective blocks is predictive of final grip strength and outcome following neurectomy.

Methods: Patients referred to the plastic surgery clinic for assessment of symptomatic first CMC joint osteoarthritis will be provided options for standard treatment or denervation procedure. Patients who agree to denervation will undergo local anesthetic block at their initial consult. At their initial consultation as well as at the 2-week, 3-month, 6-month, 12-month and 24-month post-surgical follow-up, patients will complete a QuickDASH, Kapandji score, pain scores, 2-point discrimination and grip/key/3-point strength measurements. The total patient population included in this study will be 60 patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Radiographic Eaton stage 2 or 3 1st carpometacarpal joint arthritis
  • Failed medical management, requesting surgical intervention

Exclusion Criteria:

  • Pediatric population
  • Eaton stage 1 or 4
  • Medically unfit for procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants
Patients with 1st CMC arthritis with Eaton stage 2 or 3 disease
Other: Wrist denervation procedure
To summarize, a Wagner incision is made starting over the junction of the glabrous and non-glabrous skin overlying the thumb CMC joint extending toward the distal wrist crease. The branches of the superficial radial nerve are identified as lying perpendicular to the plane overlying the fascia of the thenar muscles. The branches of the lateral antebrachial cutaneous nerve are identified and resected within the anatomic snuffbox deep to the first compartment. Finally, the thenar muscle fibers are divided at their proximal origin to identify the articular branches of the posterior cutaneous branch of the median nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain outcomes from neurectomy
Time Frame: 2 years
Participants will have their pre-operative pain scores compared to their post-operative denervation procedure evaluated with a QuickDASH questionnaire. This form will be completed at pre-operative visits and each follow-up appointment.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selective nerve block pain predictions
Time Frame: 2 years
Number of participants with changes in pain with pre-operative selective nerve blocks evaluated on the Quick DASH questionnaire will be compared to the scores on the same questionnaire following the denervation procedure at each follow-up visit.
2 years
Selective nerve block grip strength predictions
Time Frame: 2 years
Participants will have grip strength measurements with pre-operative selective nerve blocks evaluated by the key-pinch and 3-point strength tests will be compared to the grip strength measurements at each follow-up visit following the denervation procedure on the same scale.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Aaron Knox, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB24-0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Depending on interest from other Institutions across Canada who wish to participate and make this a nationwide study, we may make a plan for this data to be available to other research teams.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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