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Clinical Trials/NCT06467669
NCT06467669Not yet recruitingNot Applicable

Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation

University of Calgary0 sites60 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Pain outcomes from neurectomy

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Participants

Experimental

Patients with 1st CMC arthritis with Eaton stage 2 or 3 disease

Intervention: Wrist denervation procedure (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Selective nerve block grip strength predictions(2 years)
  • Selective nerve block pain predictions(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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